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    Clinical Trial Results:
    A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults with COVID-19.

    Summary
    EudraCT number
    		 2020-003368-24
    Trial protocol
    		 FR   GB   DE   IT   PL  
    Global end of trial date
    05 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2023
    First version publication date
    12 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-4482-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04575597
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 PHRR201209-003186: PHRR, jRCT2031210148: jRCT
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Brazil: 91
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Chile: 52
    Country: Number of subjects enrolled
    Colombia: 320
    Country: Number of subjects enrolled
    Egypt: 2
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Guatemala: 114
    Country: Number of subjects enrolled
    Israel: 12
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Japan: 8
    Country: Number of subjects enrolled
    Mexico: 150
    Country: Number of subjects enrolled
    Philippines: 27
    Country: Number of subjects enrolled
    Russian Federation: 388
    Country: Number of subjects enrolled
    South Africa: 184
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    Ukraine: 136
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    United States: 198
    Worldwide total number of subjects
    1735
    EEA total number of subjects
    37
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1526
    From 65 to 84 years
    201
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were enrolled at 123 study centers in 21 countries.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part 1: Molnupiravir 200 mg
    Arm description
    		 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Molnupiravir
    Investigational medicinal product code
    Other name
    MK-4482
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Arm title
    		 Part 1: Molnupiravir 400 mg
    Arm description
    		 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Molnupiravir
    Investigational medicinal product code
    Other name
    MK-4482
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Arm title
    		 Part 1: Molnupiravir 800 mg
    Arm description
    		 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Molnupiravir
    Investigational medicinal product code
    Other name
    MK-4482
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Arm title
    		 Part 1: Placebo
    Arm description
    		 Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Arm title
    		 Part 2: Molnupiravir 800 mg
    Arm description
    		 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Molnupiravir
    Investigational medicinal product code
    Other name
    MK-4482
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Arm title
    		 Part 2: Placebo
    Arm description
    		 Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Number of subjects in period 1
    		Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Started
    75
    77
    76
    74
    716
    717
    Treated
    74
    77
    74
    74
    710
    701
    Completed
    71
    74
    71
    69
    675
    663
    Not completed
    4
    3
    5
    5
    41
    54
         Consent withdrawn by subject
    2
    2
    4
    2
    25
    28
         Death
    -
    -
    -
    1
    3
    14
         Randomized By Mistake Without Study Treatment
    -
    -
    -
    -
    3
    2
         Not Recorded
    -
    -
    -
    -
    -
    2
         Lost to follow-up
    2
    1
    1
    2
    10
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: Molnupiravir 200 mg
    Reporting group description
    		 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 1: Molnupiravir 400 mg
    Reporting group description
    		 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 1: Molnupiravir 800 mg
    Reporting group description
    		 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 2: Molnupiravir 800 mg
    Reporting group description
    		 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 2: Placebo
    Reporting group description
    		 Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo Total
    Number of subjects
    		 75 77 76 74 716 717 1735
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 60 66 59 63 643 635 1526
        From 65-84 years
    		 15 11 17 11 71 76 201
        85 years and over
    		 0 0 0 0 2 6 8
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.5 ( 14.6 ) 49.2 ( 14.2 ) 51.0 ( 15.8 ) 47.3 ( 15.2 ) 44.4 ( 14.6 ) 45.3 ( 15.0 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 40 32 41 30 384 351 878
        Male
    		 35 45 35 44 332 366 857
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 3 1 2 5 60 44 115
        Asian
    		 0 1 0 0 26 23 50
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0
        Black or African American
    		 5 8 6 3 40 35 97
        White
    		 54 52 58 52 400 413 1029
        More than one race
    		 13 15 10 13 190 202 443
        Unknown or Not Reported
    		 0 0 0 1 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 29 30 23 33 355 356 826
        Not Hispanic or Latino
    		 46 46 51 39 355 358 895
        Unknown or Not Reported
    		 0 1 2 2 6 3 14
    Time from Symptom Onset to Randomization (Part 1)
    Randomization of participants in Part 1 of this study was stratified by the time from symptom onset prior to the day of randomization (≤5 days or >5 days). Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.
    Units: Subjects
        ≤5 Days
    		 51 52 52 50 0 0 205
        >5 Days
    		 24 25 24 24 0 0 97
        Not Applicable
    		 0 0 0 0 716 717 1433
    At Increased Risk of Severe Illness from Coronavirus Disease (COVID-19) (Part 1)
    Randomization of participants in Part 1 of this study was stratified by whether the participant was at an increased risk of severe illness from COVID-19 (At Increased Risk or Not At Increased Risk). Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.
    Units: Subjects
        At Increased Risk
    		 56 58 57 56 0 0 227
        Not At Increased Risk
    		 19 19 19 18 0 0 75
        Not Applicable
    		 0 0 0 0 716 717 1433
    Time from Symptom Onset to Randomization (Part 2)
    Randomization of participants in Part 2 of this study was stratified by the time from symptom onset prior to the day of randomization (≤3 days or >3 days). Analysis population consisted of all randomized participants in Part 2. Per protocol, this stratification factor was applicable to Part 2 of the study only.
    Units: Subjects
        ≤ 3 days
    		 0 0 0 0 342 342 684
        > 3 days
    		 0 0 0 0 374 375 749
        Not Applicable
    		 75 77 76 74 0 0 302

    End points

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    End points reporting groups
    Reporting group title
    Part 1: Molnupiravir 200 mg
    Reporting group description
    		 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 1: Molnupiravir 400 mg
    Reporting group description
    		 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 1: Molnupiravir 800 mg
    Reporting group description
    		 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 2: Molnupiravir 800 mg
    Reporting group description
    		 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 2: Placebo
    Reporting group description
    		 Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Primary: Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis)

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    End point title
    		 Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis)
    End point description
    The percentage of participants who were hospitalized and/or died through Day 29 is presented. Hospitalization (all cause) is defined as at least 24 hours of acute care in a hospital or similar acute care facility. Death was due to any cause. Any participants with an unknown survival status at Day 29 were treated as failure. The analysis in Part 2 was based on all participants enrolled by the pre-specified futility/early efficacy analysis and was used for demonstration of superiority to placebo for the primary efficacy outcome measure. All randomized participants who received at least one dose of study intervention and were not hospitalized prior to the administration of the first dose of study intervention, and, in Part 2, had reached Day 29 by the time of futility/early efficacy analysis, were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    74
    77
    74
    74
    385
    377
    Units: Percentage of Participants
        number (not applicable)
    1.4
    3.9
    4.1
    5.4
    7.3
    14.1
    Statistical analysis title
    		 Number of Participants Who Were Hospitalized/Died
    Statistical analysis description
    Difference in rates % and associated CIs were based on the Miettinen & Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Rates %
    Point estimate
    -4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.2
         upper limit
    		 2.5
    Statistical analysis title
    		 Number of Participants Who Were Hospitalized/Died
    Statistical analysis description
    Difference in rates % and associated CIs were based on the Miettinen & Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Differences in Rates %
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.6
         upper limit
    		 6.4
    Statistical analysis title
    		 Number of Participants Who Were Hospitalized/Died
    Statistical analysis description
    Difference in rates %, associated CIs, and p-value were based on the Miettinen & Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    762
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0012
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Difference in Rates %
    Point estimate
    -6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.3
         upper limit
    		 -2.4
    Statistical analysis title
    		 Number of Participants Who Were Hospitalized/Died
    Statistical analysis description
    Difference in rates % and associated CIs were based on the Miettinen & Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Rates %
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.9
         upper limit
    		 6.2

    Primary: Number of Participants With an Adverse Event (AE)

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    End point title
    		 Number of Participants With an Adverse Event (AE) [1]
    End point description
    The number of participants with at least 1 AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. All randomized participants who received at least one dose of study treatment were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 318 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics are presented.
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    74
    77
    74
    74
    710
    701
    Units: Participants
    29
    24
    29
    28
    230
    239
    No statistical analyses for this end point

    Primary: Number of Participants who Discontinued Study Intervention Due to an AE

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    End point title
    		 Number of Participants who Discontinued Study Intervention Due to an AE [2]
    End point description
    The number of participants who discontinued study intervention due to an AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. All randomized participants who received at least one dose of study treatment were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 5 days
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics are presented.
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    74
    77
    74
    74
    710
    701
    Units: Participants
    0
    0
    3
    1
    10
    20
    No statistical analyses for this end point

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough
    End point description
    Time to sustained resolution or improvement (TSRI) of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (cough) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    51
    50
    53
    48
    570
    574
    Units: Days
        median (confidence interval 95%)
    7.0 (5.0 to 10.0)
    6.5 (4.0 to 10.0)
    8.0 (6.0 to 11.0)
    6.0 (4.0 to 7.0)
    10.0 (9.0 to 11.0)
    10.0 (8.0 to 11.0)
    Statistical analysis title
    		 TSRI: Cough
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.13
    Statistical analysis title
    		 TSRI: Cough
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.18
    Statistical analysis title
    		 TSRI: Cough
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 1.11
    Statistical analysis title
    		 TSRI: Cough
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 1.08

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (sore throat) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    22
    31
    28
    30
    318
    296
    Units: Days
        median (confidence interval 95%)
    3.0 (2.0 to 4.0)
    3.0 (2.0 to 5.0)
    4.5 (3.0 to 8.0)
    5.0 (3.0 to 7.0)
    4.0 (4.0 to 5.0)
    5.0 (5.0 to 6.0)
    Statistical analysis title
    		 TSRI: Sore Throat
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 2.76
    Statistical analysis title
    		 TSRI: Sore Throat
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    614
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.33
    Statistical analysis title
    		 TSRI: Sore Throat
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.62
    Statistical analysis title
    		 TSRI: Sore Throat
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 2.09

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (nasal congestion) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    48
    41
    40
    54
    439
    429
    Units: Days
        median (confidence interval 95%)
    4.0 (3.0 to 6.0)
    4.0 (3.0 to 7.0)
    8.0 (5.0 to 10.0)
    5.0 (4.0 to 6.0)
    5.0 (4.0 to 6.0)
    6.0 (5.0 to 7.0)
    Statistical analysis title
    		 TSRI: Nasal Congestion
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.46
    Statistical analysis title
    		 TSRI: Nasal Congestion
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    868
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.23
    Statistical analysis title
    		 TSRI: Nasal Congestion
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.07
    Statistical analysis title
    		 TSRI: Nasal Congestion
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.79

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (rhinorrhea) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    31
    30
    17
    35
    348
    347
    Units: Days
        median (confidence interval 95%)
    4.0 (2.0 to 6.0)
    8.0 (5.0 to 10.0)
    9.0 (5.0 to 21.0)
    5.0 (3.0 to 6.0)
    5.0 (4.0 to 6.0)
    5.0 (5.0 to 6.0)
    Statistical analysis title
    		 TSRI: Rhinorrhoea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.83
    Statistical analysis title
    		 TSRI: Rhinorrhoea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.18
    Statistical analysis title
    		 TSRI: Rhinorrhoea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 0.85
    Statistical analysis title
    		 TSRI: Rhinorrhoea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.26

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (shortness of breath or difficulty breathing) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    20
    25
    30
    28
    258
    260
    Units: Days
        median (confidence interval 95%)
    7.0 (4.0 to 22.0)
    4.0 (3.0 to 6.0)
    9.0 (4.0 to 17.0)
    5.0 (4.0 to 12.0)
    6.0 (6.0 to 8.0)
    9.0 (6.0 to 10.0)
    Statistical analysis title
    		 TSRI: Shortness of Breath/Difficulty Breathing
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 1.34
    Statistical analysis title
    		 TSRI: Shortness of Breath/Difficulty Breathing
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    518
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.37
    Statistical analysis title
    		 TSRI: Shortness of Breath/Difficulty Breathing
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 1.42
    Statistical analysis title
    		 TSRI: Shortness of Breath/Difficulty Breathing
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 2.71

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (muscles or body aches) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    49
    42
    36
    47
    460
    454
    Units: Days
        median (confidence interval 95%)
    5.0 (3.0 to 7.0)
    4.0 (3.0 to 4.0)
    4.5 (3.0 to 15.0)
    4.0 (3.0 to 7.0)
    4.0 (4.0 to 5.0)
    5.0 (4.0 to 5.0)
    Statistical analysis title
    		 TSRI: Muscles or Body Aches
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.61
    Statistical analysis title
    		 TSRI: Muscles or Body Aches
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 1.23
    Statistical analysis title
    		 TSRI: Muscles or Body Aches
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    914
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.16
    Statistical analysis title
    		 TSRI: Muscles or Body Aches
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 2.09

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (fatigue) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    56
    51
    56
    52
    538
    528
    Units: Days
        median (confidence interval 95%)
    7.0 (4.0 to 11.0)
    5.0 (3.0 to 7.0)
    6.0 (4.0 to 11.0)
    6.0 (4.0 to 10.0)
    6.0 (6.0 to 7.0)
    7.0 (6.0 to 8.0)
    Statistical analysis title
    		 TSRI: Fatigue
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.41
    Statistical analysis title
    		 TSRI: Fatigue
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.69
    Statistical analysis title
    		 TSRI: Fatigue
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.51
    Statistical analysis title
    		 TSRI: Fatigue
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1066
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.31

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (feeling hot or feverish) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    27
    22
    38
    32
    386
    372
    Units: Days
        median (confidence interval 95%)
    4.0 (3.0 to 6.0)
    2.0 (2.0 to 3.0)
    4.0 (3.0 to 5.0)
    3.5 (2.0 to 4.0)
    3.0 (3.0 to 4.0)
    4.0 (3.0 to 4.0)
    Statistical analysis title
    		 TSRI: Feeling Hot or Feverish
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.69
    Statistical analysis title
    		 TSRI: Feeling Hot or Feverish
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    758
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.21
    Statistical analysis title
    		 TSRI: Feeling Hot or Feverish
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.38
    Statistical analysis title
    		 TSRI: Feeling Hot or Feverish
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 2

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (chills) at the time of randomization were analyzed. A value of "9999" indicates the median time to resolution/improvement and confidence interval limits were not reached due to an insufficient number of participants with sustained resolution or improvement after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    18
    18
    23
    27
    308
    279
    Units: Days
        median (confidence interval 95%)
    2.0 (2.0 to 5.0)
    2.0 (2.0 to 4.0)
    3.0 (2.0 to 3.0)
    4.0 (2.0 to 5.0)
    3.0 (2.0 to 3.0)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TSRI: Chills
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 2.76
    Statistical analysis title
    		 TSRI: Chills
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    587
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.24
    Statistical analysis title
    		 TSRI: Chills
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 2.86
    Statistical analysis title
    		 TSRI: Chills
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 3.38

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (headache) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    39
    42
    35
    37
    472
    429
    Units: Days
        median (confidence interval 95%)
    4.0 (3.0 to 6.0)
    4.0 (3.0 to 7.0)
    4.0 (3.0 to 10.0)
    6.0 (3.0 to 10.0)
    5.0 (4.0 to 5.0)
    5.0 (5.0 to 6.0)
    Statistical analysis title
    		 TSRI: Headache
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 2.2
    Statistical analysis title
    		 TSRI: Headache
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    901
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.18
    Statistical analysis title
    		 TSRI: Headache
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.65
    Statistical analysis title
    		 TSRI: Headache
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 2.31

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (nausea) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    16
    17
    10
    16
    176
    171
    Units: Days
        median (confidence interval 95%)
    5.0 (2.0 to 8.0)
    3.0 (2.0 to 4.0)
    6.0 (2.0 to 9.0)
    5.0 (2.0 to 9.0)
    4.0 (3.0 to 5.0)
    4.0 (3.0 to 4.0)
    Statistical analysis title
    		 TSRI: Nausea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 1.91
    Statistical analysis title
    		 TSRI: Nausea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    347
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.14
    Statistical analysis title
    		 TSRI: Nausea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 2.02
    Statistical analysis title
    		 TSRI: Nausea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 2.97

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (vomiting) at the time of randomization were analyzed. A value of "9999" indicates the median time to resolution/improvement and confidence interval limits were not reached due to an insufficient number of participants with sustained resolution or improvement after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    2
    2
    2
    5
    49
    38
    Units: Days
        median (confidence interval 95%)
    4.0 (2.0 to 6.0)
    8.0 (2.0 to 14.0)
    5.0 (2.0 to 8.0)
    2.0 (2.0 to 4.0)
    3.0 (2.0 to 4.0)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TSRI - Vomiting
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 1.06

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (diarrhea) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    13
    19
    15
    11
    158
    166
    Units: Days
        median (confidence interval 95%)
    6.0 (2.0 to 13.0)
    4.0 (2.0 to 4.0)
    3.0 (2.0 to 6.0)
    2.0 (2.0 to 3.0)
    3.0 (3.0 to 4.0)
    3.0 (3.0 to 4.0)
    Statistical analysis title
    		 TSRI: Diarrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.67
    Statistical analysis title
    		 TSRI: Diarrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    324
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.36
    Statistical analysis title
    		 TSRI: Diarrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.09
         upper limit
    		 0.79
    Statistical analysis title
    		 TSRI: Diarrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 0.83

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (loss of taste) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    33
    15
    18
    30
    242
    262
    Units: Days
        median (confidence interval 95%)
    6.0 (4.0 to 9.0)
    6.0 (4.0 to 11.0)
    10.0 (4.0 to 19.0)
    9.0 (5.0 to 16.0)
    9.0 (8.0 to 10.0)
    10.0 (8.0 to 12.0)
    Statistical analysis title
    		 TSRI: Loss of Taste
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 2.23
    Statistical analysis title
    		 TSRI: Loss of Taste
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.37
    Statistical analysis title
    		 TSRI: Loss of Taste
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.89
    Statistical analysis title
    		 TSRI: Loss of Taste
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.8

    Secondary: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell

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    End point title
    		 Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell
    End point description
    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (loss of smell) at the time of randomization were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    38
    29
    24
    36
    318
    323
    Units: Days
        median (confidence interval 95%)
    7.0 (6.0 to 9.0)
    10.0 (6.0 to 18.0)
    12.0 (6.0 to 19.0)
    12.0 (7.0 to 16.0)
    10.0 (9.0 to 11.0)
    11.0 (9.0 to 14.0)
    Statistical analysis title
    		 TSRI: Loss of Smell
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 2.33
    Statistical analysis title
    		 TSRI: Loss of Smell
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.72
    Statistical analysis title
    		 TSRI: Loss of Smell
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    641
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.43
    Statistical analysis title
    		 TSRI: Loss of Smell
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.48

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (cough) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    68
    70
    66
    67
    688
    672
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Cough
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 4.23
    Statistical analysis title
    		 TP: Cough
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 2.44
    Statistical analysis title
    		 TP: Cough
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 2.19
    Statistical analysis title
    		 TP: Cough
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1360
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.04

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (sore throat) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    71
    72
    70
    67
    695
    681
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Sore Throat
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 6.53
    Statistical analysis title
    		 TP: Sore Throat
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1376
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.16
    Statistical analysis title
    		 TP: Sore Throat
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 1.84
    Statistical analysis title
    		 TP: Sore Throat
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.23
         upper limit
    		 2.52

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (nasal congestion) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    71
    71
    69
    67
    682
    664
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Nasal Congestion
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 3.32
    Statistical analysis title
    		 TP: Nasal Congestion
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1346
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.1
    Statistical analysis title
    		 TP: Nasal Congestion
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 2.76
    Statistical analysis title
    		 TP: Nasal Congestion
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 3.74

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (rhinorrhea) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    71
    72
    65
    67
    694
    690
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Rhinorrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 2.52
    Statistical analysis title
    		 TP: Rhinorrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1384
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.17
    Statistical analysis title
    		 TP: Rhinorrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 3
    Statistical analysis title
    		 TP: Rhinorrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 1.9

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (shortness of breath or difficulty breathing) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    69
    73
    70
    68
    701
    681
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Shortness of Breath or Difficulty Breathing
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 1.75
    Statistical analysis title
    		 TP: Shortness of Breath or Difficulty Breathing
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1382
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.16
    Statistical analysis title
    		 TP: Shortness of Breath or Difficulty Breathing
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 1.62
    Statistical analysis title
    		 TP: Shortness of Breath or Difficulty Breathing
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 1.64

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (muscle or body aches) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    66
    71
    68
    62
    655
    640
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Muscle or Body Aches
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 1.39
    Statistical analysis title
    		 TP: Muscle or Body Aches
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 1.78
    Statistical analysis title
    		 TP: Muscle or Body Aches
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 1.39
    Statistical analysis title
    		 TP: Muscle or Body Aches
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1295
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.48

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (fatigue) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    64
    69
    62
    60
    659
    637
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Fatigue
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 1.34
    Statistical analysis title
    		 TP: Fatigue
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1296
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.21
    Statistical analysis title
    		 TP: Fatigue
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 1.74
    Statistical analysis title
    		 TP: Fatigue
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 1.37

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (feeling hot or feverish) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    68
    71
    65
    66
    676
    673
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Feeling Hot or Feverish
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 3.02
    Statistical analysis title
    		 TP: Feeling Hot or Feverish
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1349
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.11
    Statistical analysis title
    		 TP: Feeling Hot or Feverish
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 2.45
    Statistical analysis title
    		 TP: Feeling Hot or Feverish
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 2.2

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (chills) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    68
    72
    70
    66
    679
    676
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Chills
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 2.27
    Statistical analysis title
    		 TP: Chills
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1355
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.23
    Statistical analysis title
    		 TP: Chills
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.23
         upper limit
    		 1.91
    Statistical analysis title
    		 TP: Chills
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 1

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (headache) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    69
    72
    69
    67
    640
    640
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Headache
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 1.2
    Statistical analysis title
    		 TP: Headache
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1280
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.19
    Statistical analysis title
    		 TP: Headache
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.59
    Statistical analysis title
    		 TP: Headache
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 0.95

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (nausea) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    72
    73
    70
    69
    688
    686
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Nausea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 2.11
    Statistical analysis title
    		 TP: Nausea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 1.34
    Statistical analysis title
    		 TP: Nausea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 2.79
    Statistical analysis title
    		 TP: Nausea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1374
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.32

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (vomiting) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    72
    73
    71
    69
    702
    692
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Vomiting
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1394
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 1.25
    Statistical analysis title
    		 TP: Vomiting
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 15.99
    Statistical analysis title
    		 TP: Vomiting
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 9999
    Statistical analysis title
    		 TP: Vomiting
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates. A value of "999" indicates that the upper limit not reached as no events were recorded.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 15.54

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (diarrhea) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    72
    73
    68
    67
    695
    691
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Diarrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 3.83
    Statistical analysis title
    		 TP: Diarrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1386
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.1
    Statistical analysis title
    		 TP: Diarrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 3.93
    Statistical analysis title
    		 TP: Diarrhea
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 3.05

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (loss of taste) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    38
    56
    48
    37
    461
    433
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Loss of Taste
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 1.21
    Statistical analysis title
    		 TP: Loss of Taste
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    894
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.2
    Statistical analysis title
    		 TP: Loss of Taste
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 1.89
    Statistical analysis title
    		 TP: Loss of Taste
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 1.36

    Secondary: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell

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    End point title
    		 Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell
    End point description
    Time to progression (TP) of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (loss of smell) at the time of randomization were analyzed. A value of "9999" indicates that the median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.
    End point type
    Secondary
    End point timeframe
    Up to 29 days
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    33
    42
    42
    31
    385
    372
    Units: Days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Statistical analysis title
    		 TP: Loss of Smell
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.09
         upper limit
    		 1.33
    Statistical analysis title
    		 TP: Loss of Smell
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    757
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.04
    Statistical analysis title
    		 TP: Loss of Smell
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.18
         upper limit
    		 1.48
    Statistical analysis title
    		 TP: Loss of Smell
    Statistical analysis description
    Hazard ratio and associated CIs were based on Cox regression model with Efron’s method of tie handling with treatment and randomization stratification factors as covariates.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 2.15

    Secondary: Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3

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    End point title
    		 Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3
    End point description
    The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. All randomized participants who received at least one dose of study treatment and have data at the relevant time point were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 3
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    74
    77
    74
    74
    709
    699
    Units: Participants
        0 (n=72,75,73,70,695,684)
    2
    0
    0
    1
    2
    3
        1 (n=72,75,73,70,695,684)
    2
    2
    1
    1
    11
    13
        2 (n=72,75,73,70,695,684)
    68
    72
    66
    66
    655
    640
        3 (n=72,75,73,70,695,684)
    0
    0
    2
    2
    13
    10
        4 (n=72,75,73,70,695,684)
    0
    1
    3
    0
    7
    4
        5 (n=72,75,73,70,695,684)
    0
    0
    1
    0
    4
    13
        6 (n=72,75,73,70,695,684)
    0
    0
    0
    0
    3
    1
        7 (n=72,75,73,70,695,684)
    0
    0
    0
    0
    0
    0
        8 (n=72,75,73,70,695,684)
    0
    0
    0
    0
    0
    0
        9 (n=72,75,73,70,695,684)
    0
    0
    0
    0
    0
    0
        10 (n=72,75,73,70,695,684)
    0
    0
    0
    0
    0
    0
        Missing (n=74,77,74,74,709,699)
    2
    2
    1
    4
    14
    15
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 3
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 15.59
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 3
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1408
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 2.3
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 3
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.09
         upper limit
    		 1.44
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 3
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 6.16

    Secondary: Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5])

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    End point title
    		 Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5])
    End point description
    The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. All randomized participants who received at least one dose of study treatment and have data at the relevant time point were analyzed.
    End point type
    Secondary
    End point timeframe
    EOT (Day 5)
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    74
    77
    74
    74
    709
    699
    Units: Participants
        0 (n=70,75,71,70,697,684)
    3
    0
    2
    1
    11
    10
        1 (n=70,75,71,70,697,684)
    9
    5
    3
    3
    36
    34
        2 (n=70,75,71,70,697,684)
    58
    69
    63
    65
    613
    593
        3 (n=70,75,71,70,697,684)
    0
    0
    0
    1
    14
    9
        4 (n=70,75,71,70,697,684)
    0
    0
    1
    0
    10
    13
        5 (n=70,75,71,70,697,684)
    0
    1
    1
    0
    7
    21
        6 (n=70,75,71,70,697,684)
    0
    0
    0
    0
    5
    2
        7 (n=70,75,71,70,697,684)
    0
    0
    0
    0
    0
    1
        8 (n=70,75,71,70,697,684)
    0
    0
    1
    0
    0
    1
        9 (n=70,75,71,70,697,684)
    0
    0
    0
    0
    1
    0
        10 (n=70,75,71,70,697,684)
    0
    0
    0
    0
    0
    0
        Missing (n=74,77,74,74,709,699)
    4
    2
    3
    4
    12
    15
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 5
    Statistical analysis description
    Odds ratio was on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.14
         upper limit
    		 11.88
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 5
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1408
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 2.39
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 5
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 2.68
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 5
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 3.98

    Secondary: Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10

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    End point title
    		 Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10
    End point description
    The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. All randomized participants who received at least one dose of study treatment and have data at the relevant time point were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 10
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    74
    77
    74
    74
    709
    699
    Units: Participants
        0 (n=70,73,69,69,673,673)
    9
    11
    3
    4
    40
    32
        1 (n=70,73,69,69,673,673)
    15
    8
    7
    13
    68
    81
        2 (n=70,73,69,69,673,673)
    45
    52
    56
    49
    519
    493
        3 (n=70,73,69,69,673,673)
    0
    0
    0
    0
    12
    6
        4 (n=70,73,69,69,673,673)
    0
    0
    1
    2
    16
    23
        5 (n=70,73,69,69,673,673)
    1
    1
    1
    1
    11
    21
        6 (n=70,73,69,69,673,673)
    0
    1
    0
    0
    4
    11
        7 (n=70,73,69,69,673,673)
    0
    0
    0
    0
    1
    2
        8 (n=70,73,69,69,673,673)
    0
    0
    1
    0
    2
    3
        9 (n=70,73,69,69,673,673)
    0
    0
    0
    0
    0
    1
        10 (n=70,73,69,69,673,673)
    0
    0
    0
    0
    0
    0
        Missing (n=74,77,74,74,709,699)
    4
    4
    5
    5
    36
    26
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 10
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 3.45
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 10
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1408
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.14
         upper limit
    		 2.2
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 10
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 1.29
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 10
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 2.33

    Secondary: Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15

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    End point title
    		 Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15
    End point description
    The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. All randomized participants who received at least one dose of study treatment and have data at the relevant time point were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 15
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    74
    77
    74
    74
    709
    699
    Units: Participants
        0 (n=72,73,70,69,669,667)
    20
    21
    13
    11
    102
    94
        1 (n=72,73,70,69,669,667)
    15
    8
    9
    17
    110
    92
        2 (n=72,73,70,69,669,667)
    36
    43
    45
    39
    433
    427
        3 (n=72,73,70,69,669,667)
    0
    0
    0
    0
    5
    6
        4 (n=72,73,70,69,669,667)
    1
    0
    1
    2
    11
    21
        5 (n=72,73,70,69,669,667)
    0
    0
    1
    0
    4
    12
        6 (n=72,73,70,69,669,667)
    0
    1
    0
    0
    1
    6
        7 (n=72,73,70,69,669,667)
    0
    0
    0
    0
    1
    2
        8 (n=72,73,70,69,669,667)
    0
    0
    1
    0
    2
    2
        9 (n=72,73,70,69,669,667)
    0
    0
    0
    0
    0
    0
        10 (n=72,73,70,69,669,667)
    0
    0
    0
    0
    0
    5
        Missing (n=74,77,74,74,709,699)
    2
    4
    4
    5
    40
    32
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 15
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 2.73
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 15
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1408
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 1.78
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 15
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 1.32
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 15
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.94

    Secondary: Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29

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    End point title
    		 Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29
    End point description
    The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. All randomized participants who received at least one dose of study treatment and have data at the relevant time point were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    74
    77
    74
    74
    709
    699
    Units: Participants
        0 (n=68,72,66,67,645,650)
    35
    40
    39
    36
    312
    314
        1 (n=68,72,66,67,645,650)
    14
    13
    10
    16
    126
    115
        2 (n=68,72,66,67,645,650)
    19
    19
    15
    14
    197
    198
        3 (n=68,72,66,67,645,650)
    0
    0
    0
    0
    1
    1
        4 (n=68,72,66,67,645,650)
    0
    0
    2
    1
    4
    10
        5 (n=68,72,66,67,645,650)
    0
    0
    0
    0
    2
    2
        6 (n=68,72,66,67,645,650)
    0
    0
    0
    0
    0
    0
        7 (n=68,72,66,67,645,650)
    0
    0
    0
    0
    0
    1
        8 (n=68,72,66,67,645,650)
    0
    0
    0
    0
    2
    0
        9 (n=68,72,66,67,645,650)
    0
    0
    0
    0
    0
    0
        10 (n=68,72,66,67,645,650)
    0
    0
    0
    0
    1
    9
        Missing (n=74,77,74,74,709,699)
    6
    5
    8
    7
    64
    49
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 29
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 1.66
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 29
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1408
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.29
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 29
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.81
    Statistical analysis title
    		 WHO 11-point Ordinal Outcomes Score: Day 29
    Statistical analysis description
    Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 1.79

    Post-hoc: Percentage of Participants Who Were Hospitalized and/or Died Through Day 29

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    End point title
    		 Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 [3]
    End point description
    The percentage of participants who were hospitalized and/or died through Day 29 is presented. Hospitalization (all cause) is defined as at least 24 hours of acute care in a hospital or similar acute care facility. Death was due to any cause. Any participants with an unknown survival status at Day 29 were treated as failure. This analysis was based on all randomized participants in Part 2 who received at least one dose of study treatment, were not hospitalized prior to the administration of the first dose of study intervention, and had reached Day 29 post treatment. All randomized participants in Part 2 who received at least one dose of study intervention and were not hospitalized prior to the administration of the first dose of study intervention were analyzed.
    End point type
    Post-hoc
    End point timeframe
    Up to 29 days
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only applicable to Part 2 of the study.
    End point values
    		 Part 2: Molnupiravir 800 mg Part 2: Placebo
    Number of subjects analysed
    709
    699
    Units: Percentage of Participants
        number (not applicable)
    6.8
    9.7
    Statistical analysis title
    		 Number of Participants Who Were Hospitalized/Died
    Statistical analysis description
    Difference in rates % and associated CIs were based on the Miettinen & Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.
    Comparison groups
    Part 2: Molnupiravir 800 mg v Part 2: Placebo
    Number of subjects included in analysis
    1408
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Rates %
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.9
         upper limit
    		 -0.1

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 318 days
    Adverse event reporting additional description
    The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Part 1: Molnupiravir 200 mg
    Reporting group description
    		 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 1: Molnupiravir 400 mg
    Reporting group description
    		 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 1: Molnupiravir 800 mg
    Reporting group description
    		 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 2: Molnupiravir 800 mg
    Reporting group description
    		 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Reporting group title
    Part 2: Placebo
    Reporting group description
    		 Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Serious adverse events
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 74 (1.35%)
    3 / 77 (3.90%)
    4 / 74 (5.41%)
    5 / 74 (6.76%)
    51 / 710 (7.18%)
    67 / 701 (9.56%)
         number of deaths (all causes)
    0
    0
    0
    1
    4
    16
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lung
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Vascular disorders
    Shock
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    1 / 74 (1.35%)
    0 / 710 (0.00%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis mesenteric vessel
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    1 / 74 (1.35%)
    0 / 710 (0.00%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    2 / 701 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cough
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 77 (1.30%)
    0 / 74 (0.00%)
    1 / 74 (1.35%)
    1 / 710 (0.14%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    6 / 710 (0.85%)
    9 / 701 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 77 (1.30%)
    2 / 74 (2.70%)
    1 / 74 (1.35%)
    37 / 710 (5.21%)
    53 / 701 (7.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    0 / 37
    0 / 53
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 9
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 74 (1.35%)
    2 / 77 (2.60%)
    2 / 74 (2.70%)
    2 / 74 (2.70%)
    29 / 710 (4.08%)
    43 / 701 (6.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 2
    0 / 29
    0 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 5
    Lung abscess
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillitis
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    1 / 74 (1.35%)
    0 / 74 (0.00%)
    2 / 710 (0.28%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    0 / 701 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Septic shock
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    3 / 710 (0.42%)
    2 / 701 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 710 (0.14%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    1 / 74 (1.35%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 77 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 710 (0.00%)
    1 / 701 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir 800 mg Part 2: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 74 (8.11%)
    4 / 77 (5.19%)
    5 / 74 (6.76%)
    9 / 74 (12.16%)
    38 / 710 (5.35%)
    38 / 701 (5.42%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 74 (4.05%)
    2 / 77 (2.60%)
    2 / 74 (2.70%)
    4 / 74 (5.41%)
    16 / 710 (2.25%)
    21 / 701 (3.00%)
         occurrences all number
    3
    2
    2
    5
    17
    22
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 74 (4.05%)
    2 / 77 (2.60%)
    3 / 74 (4.05%)
    5 / 74 (6.76%)
    23 / 710 (3.24%)
    17 / 701 (2.43%)
         occurrences all number
    3
    2
    3
    5
    24
    17

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jan 2021
    AM1: To revise the dose selection process before initiation of Part 2 (Phase 3), update the benefit/risk assessment, clarify the key secondary efficacy objective regarding COVID-19 signs/symptoms, and add a discontinuation criterion.
    27 Apr 2021
    AM2: To provide the selected dose and the dose selection rationale for Part 2 (Phase 3) of the study, revise female and male contraception requirements, update the stratification factors, revise entry criteria, and increase the sample size for Part 2 (Phase 3).
    17 Jul 2021
    AM3: To clarify that participants can only enroll in this study if they have chosen not to receive a SARS-CoV-2 monoclonal antibody(ies) or SARS-CoV-2 monoclonal antibodies have not been authorized or approved in their country, update the benefit/risk assessment, add new subgroup analyses, and add a description of an unblinded team in the case of a positive efficacy finding noted by the eDMC at interim analysis (IA) 4.
    24 Aug 2021
    AM4: To remove the enrollment target of ~50% of Part 2 participants who are >60 years of age and to add a new exploratory objective for detection of infectious virus from nasopharyngeal (NP) swabs.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    02 Oct 2021
    At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study was stopped early at a planned IA.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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