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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 Hospitalized Adults with COVID-19

    Summary
    EudraCT number
    		 2020-003367-26
    Trial protocol
    		 FR   GB   SE   PL   IT  
    Global end of trial date
    11 Aug 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    16 Dec 2022
    First version publication date
    10 Aug 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-4482-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04575584
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 PHRR: PHRR201210-003189, jRCT: jRCT2031200404
    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
    11 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 2021
    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 rate of sustained recovery through Day 29. This study was intended to include two parts: Part 1 was a dose-ranging phase 2 study, and Part 2 was a phase 3 study to evaluate the dose selected in Part 1. However, this study was terminated due to business reasons prior to conducting Part 2. Participants in Part 1 were followed until Month 7.
    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
    Brazil: 32
    Country: Number of subjects enrolled
    Chile: 8
    Country: Number of subjects enrolled
    Colombia: 23
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    Israel: 15
    Country: Number of subjects enrolled
    Korea, Republic of: 12
    Country: Number of subjects enrolled
    Mexico: 23
    Country: Number of subjects enrolled
    Philippines: 1
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Russian Federation: 42
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    Ukraine: 25
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    United States: 46
    Country: Number of subjects enrolled
    Spain: 34
    Worldwide total number of subjects
    304
    EEA total number of subjects
    55
    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)
    205
    From 65 to 84 years
    93
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were enrolled at 86 study centers in 15 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
    Molnupiravir capsule taken by mouth every 12 hours for 5 days

    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
    Molnupiravir capsule taken by mouth every 12 hours for 5 days

    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
    Molnupiravir capsule taken by mouth every 12 hours for 5 days

    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 capsule matched to molnupiravir taken by mouth every 12 hours for 5 days

    Number of subjects in period 1
    		Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo
    Started
    75
    75
    76
    78
    Treated
    73
    73
    72
    75
    Completed
    61
    60
    63
    70
    Not completed
    14
    15
    13
    8
         Not recorded
    -
    -
    -
    1
         Consent withdrawn by subject
    7
    9
    5
    3
         Physician decision
    -
    1
    1
    1
         Death
    6
    4
    6
    2
         Lost to follow-up
    1
    1
    1
    1

    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 values
    		 Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Total
    Number of subjects
    		 75 75 76 78 304
    Age categorical
    Units: participants
        Adults (18-64 years)
    		 51 50 53 51 205
        From 65-84 years
    		 22 23 23 25 93
        85 years and over
    		 2 2 0 2 6
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.9 ± 14.2 57.0 ± 14.0 56.8 ± 13.7 57.1 ± 14.2 -
    Sex: Female, Male
    Units: participants
        Female
    		 32 34 32 34 132
        Male
    		 43 41 44 44 172
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 3 1 2 6
        Asian
    		 10 8 4 1 23
        Native Hawaiian or Other Pacific Islander
    		 0 0 1 0 1
        Black or African American
    		 1 4 6 7 18
        White
    		 58 52 54 63 227
        More than one race
    		 6 7 9 5 27
        Unknown or Not Reported
    		 0 1 1 0 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 27 32 28 27 114
        Not Hispanic or Latino
    		 47 42 46 49 184
        Unknown or Not Reported
    		 1 1 2 2 6

    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)

    Primary: Time-to-sustained recovery

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    End point title
    		 Time-to-sustained recovery
    End point description
    The median time to sustained recovery is reported. Sustained recovery is defined as 1) the participant is alive and not hospitalized; or 2) the participant is alive and medically ready for discharge as determined by the investigator. All randomized participants in Part 1 who received ≥1 dose of study drug are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: days
        median (confidence interval 95%)
    9.0 (7.0 to 10.0)
    9.0 (8.0 to 10.0)
    9.0 (8.0 to 11.0)
    9.0 (8.0 to 11.0)
    Statistical analysis title
    		 Time to Recovery: Molnupiravir 200 mg vs. Placebo
    Statistical analysis description
    Based on Cox regression model with Efron’s method of tie handling.
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.562
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.45
    Statistical analysis title
    		 Time to Recovery: Molnupiravir 800 mg vs. Placebo
    Statistical analysis description
    Based on Cox regression model with Efron’s method of tie handling.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4894
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.47
    Statistical analysis title
    		 Time to Recovery: Molnupiravir 400 mg vs. Placebo
    Statistical analysis description
    Based on Cox regression model with Efron’s method of tie handling.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3145
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.65

    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 in Part 1 who received ≥1 dose of study drug are included.
    End point type
    Primary
    End point timeframe
    Up to 19 days (during treatment and 14-day follow-up)
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
    40
    36
    45
    46
    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 discontinuing from study treatment 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 in Part 1 who received ≥1 dose of study drug are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with all-cause mortality

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    End point title
    		 Number of participants with all-cause mortality
    End point description
    The number of participants with all-cause mortality (ACM) through Day 29 is presented. All-cause mortality is defined as death due to any cause. Any participants with an unknown survival status at Day 29 were imputed as deceased. All randomized participants in Part 1 who received ≥1 dose of study drug are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
    4
    5
    4
    1
    Statistical analysis title
    		 ACM: Molnupiravir 200 mg vs. Placebo
    Statistical analysis description
    Unknown Day 29 survival status 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
    		 superiority
    P-value
    		 = 0.1642
    Method
    		 Miettinen and Nurminen method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 12.1
    Statistical analysis title
    		 ACM: Molnupiravir 400 mg vs. Placebo
    Statistical analysis description
    Unknown Day 29 survival status was treated as failure.
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.09
    Method
    		 Miettinen and Nurminen method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 13.9
    Statistical analysis title
    		 ACM: Molnupiravir 800 mg vs. Placebo
    Statistical analysis description
    Unknown Day 29 survival status was treated as failure.
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1594
    Method
    		 Miettinen and Nurminen method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 12.3

    Secondary: Odds of a more favorable response on Pulmonary ordinal outcome score on Day 3

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    End point title
    		 Odds of a more favorable response on Pulmonary ordinal outcome score on Day 3
    End point description
    Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented. All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        1 (n=72,72,72,73)
    25
    20
    21
    16
        2 (n=72,72,72,73)
    2
    7
    0
    7
        3 (n=72,72,72,73)
    21
    20
    23
    25
        4 (n=72,72,72,73)
    16
    16
    19
    14
        5 (n=72,72,72,73)
    7
    9
    6
    10
        6 (n=72,72,72,73)
    1
    0
    3
    1
        7 (n=72,72,72,73)
    0
    0
    0
    0
        Missing (n=73,73,72,75)
    1
    1
    0
    2
    Statistical analysis title
    		 Pulmonary Day 3: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3623
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 2.35
    Statistical analysis title
    		 Pulmonary Day 3: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9313
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.75
    Statistical analysis title
    		 Pulmonary Day 3: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5714
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 2.12

    Secondary: Odds of a more favorable response on Pulmonary ordinal outcome score on End of Treatment (EOT [Day 5])

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    End point title
    		 Odds of a more favorable response on Pulmonary ordinal outcome score on End of Treatment (EOT [Day 5])
    End point description
    Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented. All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        1 (n=71,68,70,70)
    30
    22
    26
    27
        2 (n=71,68,70,70)
    6
    5
    4
    4
        3 (n=71,68,70,70)
    17
    18
    15
    16
        4 (n=71,68,70,70)
    10
    14
    14
    14
        5 (n=71,68,70,70)
    7
    8
    8
    8
        6 (n=71,68,70,70)
    1
    1
    3
    1
        7 (n=71,68,70,70)
    0
    0
    0
    0
        Missing (n=73,73,72,75)
    2
    5
    2
    5
    Statistical analysis title
    		 Pulmonary Day 5: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4398
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.3
    Statistical analysis title
    		 Pulmonary Day 5: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7069
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.62
    Statistical analysis title
    		 Pulmonary Day 5: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6277
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 1.57

    Secondary: Odds of a more favorable response on Pulmonary ordinal outcome score on Day 10

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    End point title
    		 Odds of a more favorable response on Pulmonary ordinal outcome score on Day 10
    End point description
    Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented. All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        1 (n=68,64,67,70)
    44
    39
    33
    38
        2 (n=68,64,67,70)
    4
    4
    4
    5
        3 (n=68,64,67,70)
    8
    8
    14
    10
        4 (n=68,64,67,70)
    5
    7
    8
    10
        5 (n=68,64,67,70)
    4
    3
    5
    4
        6 (n=68,64,67,70)
    3
    0
    3
    3
        7 (n=68,64,67,70)
    0
    3
    0
    0
        Missing (n=73,73,72,75)
    5
    9
    5
    5
    Statistical analysis title
    		 Pulmonary Day 10: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2422
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 2.85
    Statistical analysis title
    		 Pulmonary Day 10: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4789
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 2.44
    Statistical analysis title
    		 Pulmonary Day 10: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6052
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.59

    Secondary: Odds of a more favorable response on Pulmonary ordinal outcome score on Day 15

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    End point title
    		 Odds of a more favorable response on Pulmonary ordinal outcome score on Day 15
    End point description
    Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented. All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        1 (n=67,62,68,71)
    45
    44
    41
    42
        2 (n=67,62,68,71)
    7
    2
    2
    5
        3 (n=67,62,68,71)
    6
    6
    14
    10
        4 (n=67,62,68,71)
    3
    5
    3
    6
        5 (n=67,62,68,71)
    2
    1
    0
    4
        6 (n=67,62,68,71)
    4
    1
    7
    3
        7 (n=67,62,68,71)
    0
    3
    1
    1
        Missing (n=73,73,72,75)
    6
    11
    4
    4
    Statistical analysis title
    		 Pulmonary Day 15: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2644
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 2.88
    Statistical analysis title
    		 Pulmonary Day 15: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2184
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 3.14
    Statistical analysis title
    		 Pulmonary Day 15: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9771
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.94

    Secondary: Odds of a more favorable response on Pulmonary ordinal outcome score on Day 29

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    End point title
    		 Odds of a more favorable response on Pulmonary ordinal outcome score on Day 29
    End point description
    Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented. All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        1 (n=63,59,69,69)
    46
    47
    47
    49
        2 (n=63,59,69,69)
    2
    2
    2
    5
        3 (n=63,59,69,69)
    4
    5
    9
    7
        4 (n=63,59,69,69)
    5
    1
    3
    5
        5 (n=63,59,69,69)
    0
    0
    0
    0
        6 (n=63,59,69,69)
    2
    0
    5
    2
        7 (n=63,59,69,69)
    4
    4
    3
    1
        Missing (n=73,73,72,75)
    10
    14
    3
    6
    Statistical analysis title
    		 Pulmonary Day 29: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9945
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 2.06
    Statistical analysis title
    		 Pulmonary Day 15: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3227
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 3.37
    Statistical analysis title
    		 Pulmonary Day 15: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.52
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 1.61

    Secondary: Odds of a more favorable response on Pulmonary+ ordinal outcome score on Day 3

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    End point title
    		 Odds of a more favorable response on Pulmonary+ ordinal outcome score on Day 3
    End point description
    Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented. All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        1 (n=72,72,72,73)
    25
    20
    21
    16
        2 (n=72,72,72,73)
    2
    7
    0
    7
        3 (n=72,72,72,73)
    20
    20
    23
    25
        4 (n=72,72,72,73)
    16
    16
    19
    14
        5 (n=72,72,72,73)
    7
    9
    6
    10
        6 (n=72,72,72,73)
    2
    0
    3
    1
        7 (n=72,72,72,73)
    0
    0
    0
    0
        Missing (n=73,73,72,75)
    1
    1
    0
    2
    Statistical analysis title
    		 Pulmonary+ Day 3: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4472
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.25
    Statistical analysis title
    		 Pulmonary+ Day 3: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9313
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.75
    Statistical analysis title
    		 Pulmonary+ Day 3: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5714
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 2.12

    Secondary: Odds of a more favorable response on Pulmonary+ ordinal outcome score on EOT (Day 5)

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    End point title
    		 Odds of a more favorable response on Pulmonary+ ordinal outcome score on EOT (Day 5)
    End point description
    Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented. All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        1 (n=71,68,70,70)
    30
    22
    26
    27
        2 (n=71,68,70,70)
    6
    5
    4
    4
        3 (n=71,68,70,70)
    16
    18
    15
    16
        4 (n=71,68,70,70)
    10
    14
    14
    14
        5 (n=71,68,70,70)
    7
    8
    8
    8
        6 (n=71,68,70,70)
    2
    1
    3
    1
        7 (n=71,68,70,70)
    0
    0
    0
    0
        Missing (n=73,73,72,75)
    2
    5
    2
    5
    Statistical analysis title
    		 Pulmonary+ Day 5: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5222
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 2.21
    Statistical analysis title
    		 Pulmonary+ Day 5: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6277
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 1.57
    Statistical analysis title
    		 Pulmonary+ Day 5: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7069
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.62

    Secondary: Odds of a more favorable response on Pulmonary+ ordinal outcome score on Day 10

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    End point title
    		 Odds of a more favorable response on Pulmonary+ ordinal outcome score on Day 10
    End point description
    Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented. All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        1 (n=68,64,67,70)
    44
    39
    33
    38
        2 (n=68,64,67,70)
    4
    4
    4
    5
        3 (n=68,64,67,70)
    8
    8
    14
    10
        4 (n=68,64,67,70)
    4
    7
    8
    10
        5 (n=68,64,67,70)
    4
    3
    4
    4
        6 (n=68,64,67,70)
    4
    0
    4
    3
        7 (n=68,64,67,70)
    0
    3
    0
    0
        Missing (n=73,73,72,75)
    5
    9
    5
    5
    Statistical analysis title
    		 Pulmonary+ Day 10: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2627
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 2.8
    Statistical analysis title
    		 Pulmonary+ Day 10: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5938
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.58
    Statistical analysis title
    		 Pulmonary+ Day 10: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4789
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 2.44

    Secondary: Odds of a more favorable response on Pulmonary+ ordinal outcome score on Day 15

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    End point title
    		 Odds of a more favorable response on Pulmonary+ ordinal outcome score on Day 15
    End point description
    Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented. All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        1 (n=67,62,68,71)
    45
    44
    41
    42
        2 (n=67,62,68,71)
    7
    2
    2
    5
        3 (n=67,62,68,71)
    6
    6
    14
    10
        4 (n=67,62,68,71)
    3
    5
    3
    6
        5 (n=67,62,68,71)
    2
    1
    0
    4
        6 (n=67,62,68,71)
    4
    1
    7
    3
        7 (n=67,62,68,71)
    0
    3
    1
    1
        Missing (n=73,73,72,75)
    6
    11
    4
    4
    Statistical analysis title
    		 Pulmonary+ Day 15: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2644
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 2.88
    Statistical analysis title
    		 Pulmonary+ Day 15: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2184
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 3.14
    Statistical analysis title
    		 Pulmonary+ Day 15: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9771
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.94

    Secondary: Odds of a more favorable response on Pulmonary+ ordinal outcome score on Day 29

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    End point title
    		 Odds of a more favorable response on Pulmonary+ ordinal outcome score on Day 29
    End point description
    Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented. All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        1 (n=63,59,69,69)
    46
    47
    47
    49
        2 (n=63,59,69,69)
    2
    2
    2
    5
        3 (n=63,59,69,69)
    4
    5
    9
    7
        4 (n=63,59,69,69)
    5
    1
    3
    5
        5 (n=63,59,69,69)
    0
    0
    0
    0
        6 (n=63,59,69,69)
    2
    0
    5
    2
        7 (n=63,59,69,69)
    4
    4
    3
    1
        Missing (n=63,59,69,69)
    10
    14
    3
    6
    Statistical analysis title
    		 Pulmonary+ Day 29: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9445
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 2.06
    Statistical analysis title
    		 Pulmonary+ Day 29: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3227
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 3.37
    Statistical analysis title
    		 Pulmonary+ Day 29: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.52
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 1.61

    Secondary: Odds of a more favorable response in the clinical risk of mortality category from the National Early Warning Score (NEWS)

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    End point title
    		 Odds of a more favorable response in the clinical risk of mortality category from the National Early Warning Score (NEWS)
    End point description
    NEWS (Royal College of Physicians, 2012) assesses a participant’s degree of illness as assessed by clinical risk prediction categories based on a set of vital sign measurements. There are 7 physiological parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0 to 3 was allocated to each parameter except supplemental oxygen use (score of 0 [no] or 2 [yes]) and level of consciousness (score of 0 or 3 with 0 = normal health condition and 3 = worst health condition). All scores were summed to get an aggregate score. Aggregate NEWS score ranged from 0 to 19, with higher scores meaning more severity/higher risk: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19). All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        Low (n=70,64,69,69)
    57
    45
    52
    55
        Medium (n=70,64,69,69)
    8
    8
    9
    11
        High (n=70,64,69,69)
    5
    11
    8
    3
        Missing (n=70,64,69,69)
    3
    9
    3
    6
    Statistical analysis title
    		 NEWS: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8732
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 2.47
    Statistical analysis title
    		 NEWS: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1277
    Method
    		 Wald Chi-square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 1.19
    Statistical analysis title
    		 NEWS: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4326
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 1.61

    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 in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        0 (n=73,73,72,75)
    0
    0
    0
    0
        1 (n=73,73,72,75)
    0
    0
    0
    0
        2 (n=73,73,72,75)
    1
    1
    0
    2
        3 (n=73,73,72,75)
    1
    0
    0
    1
        4 (n=73,73,72,75)
    27
    27
    21
    24
        5 (n=73,73,72,75)
    36
    36
    42
    37
        6 (n=73,73,72,75)
    7
    9
    6
    10
        7 (n=73,73,72,75)
    0
    0
    0
    0
        8 (n=73,73,72,75)
    0
    0
    2
    0
        9 (n=73,73,72,75)
    1
    0
    1
    1
        10 (n=73,73,72,75)
    0
    0
    0
    0
        Missing (n=73,73,72,75)
    0
    0
    0
    0
    Statistical analysis title
    		 WHO Day 3: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.683
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 2.88
    Statistical analysis title
    		 WHO Day 3: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8244
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 2.2
    Statistical analysis title
    		 WHO Day 3: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 2.39

    Secondary: Odds of a more favorable response on WHO 11-point ordinal outcomes score on a scale on 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 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 in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        0 (n=71,68,70,72)
    2
    0
    1
    0
        1 (n=71,68,70,72)
    2
    1
    1
    2
        2 (n=71,68,70,72)
    3
    5
    0
    9
        3 (n=71,68,70,72)
    0
    2
    2
    1
        4 (n=71,68,70,72)
    29
    20
    27
    25
        5 (n=71,68,70,72)
    27
    31
    28
    26
        6 (n=71,68,70,72)
    7
    8
    8
    8
        7 (n=71,68,70,72)
    0
    0
    0
    0
        8 (n=71,68,70,72)
    1
    1
    1
    0
        9 (n=71,68,70,72)
    0
    0
    2
    1
        10 (n=71,68,70,72)
    0
    0
    0
    0
        Missing (n=71,68,70,72)
    2
    5
    2
    3
    Statistical analysis title
    		 WHO Day 5: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5022
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 1.64
    Statistical analysis title
    		 WHO Day 5: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0991
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 1.13
    Statistical analysis title
    		 WHO Day 5: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5204
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.64

    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 in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        0 (n=68,64,67,69)
    3
    4
    2
    3
        1 (n=68,64,67,69)
    10
    7
    7
    7
        2 (n=68,64,67,69)
    26
    19
    22
    21
        3 (n=68,64,67,69)
    3
    4
    7
    8
        4 (n=68,64,67,69)
    8
    16
    7
    13
        5 (n=68,64,67,69)
    11
    9
    14
    11
        6 (n=68,64,67,69)
    4
    2
    5
    3
        7 (n=68,64,67,69)
    0
    0
    1
    0
        8 (n=68,64,67,69)
    2
    0
    0
    3
        9 (n=68,64,67,69)
    1
    0
    2
    0
        10 (n=68,64,67,69)
    0
    3
    0
    0
        Missing (n=68,64,67,69)
    5
    9
    5
    6
    Statistical analysis title
    		 WHO Day 10: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6346
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 2.29
    Statistical analysis title
    		 WHO Day 10: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8879
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.84
    Statistical analysis title
    		 WHO Day 10: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7596
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 1.75

    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 in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        0 (n=67,61,68,70)
    10
    8
    10
    8
        1 (n=67,61,68,70)
    12
    12
    9
    11
        2 (n=67,61,68,70)
    25
    25
    27
    27
        3 (n=67,61,68,70)
    7
    5
    4
    8
        4 (n=67,61,68,70)
    4
    3
    3
    5
        5 (n=67,61,68,70)
    4
    4
    7
    4
        6 (n=67,61,68,70)
    2
    0
    0
    3
        7 (n=67,61,68,70)
    0
    0
    2
    1
        8 (n=67,61,68,70)
    3
    0
    1
    0
        9 (n=67,61,68,70)
    0
    1
    4
    2
        10 (n=67,61,68,70)
    0
    3
    1
    1
        Missing (n=67,61,68,70)
    6
    12
    4
    5
    Statistical analysis title
    		 WHO Day 15: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6002
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 2.82
    Statistical analysis title
    		 WHO Day 15: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.622
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 1.78
    Statistical analysis title
    		 WHO Day 15: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4733
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 3.21

    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 in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
    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
    Number of subjects analysed
    73
    73
    72
    75
    Units: participants
        0 (n=63,59,68,69)
    25
    17
    29
    22
        1 (n=63,59,68,69)
    4
    13
    7
    9
        2 (n=63,59,68,69)
    24
    21
    17
    24
        3 (n=63,59,68,69)
    3
    2
    7
    7
        4 (n=63,59,68,69)
    0
    2
    0
    0
        5 (n=63,59,68,69)
    1
    0
    0
    4
        6 (n=63,59,68,69)
    0
    0
    0
    0
        7 (n=63,59,68,69)
    0
    0
    2
    0
        8 (n=63,59,68,69)
    2
    0
    2
    2
        9 (n=63,59,68,69)
    0
    0
    1
    0
        10 (n=63,59,68,69)
    4
    4
    3
    1
        Missing (n=63,59,68,69)
    10
    14
    4
    6
    Statistical analysis title
    		 WHO Day 29: Molnupiravir 200 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 200 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7871
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 2.6
    Statistical analysis title
    		 WHO Day 29: Molnupiravir 400 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 400 mg v Part 1: Placebo
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9598
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 3.06
    Statistical analysis title
    		 WHO Day 29: Molnupiravir 800 mg vs. Placebo
    Comparison groups
    Part 1: Molnupiravir 800 mg v Part 1: Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.667
    Method
    		 Wald Chi-Square
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 2.31

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 7 months
    Adverse event reporting additional description
    All randomized participants are included in the all-cause mortality assessment; only confirmed (no imputed) deaths are reported. All participants who received ≥1 dose of study treatment are included in the assessment of serious adverse events (SAEs) and nonserious AEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    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: Placebo
    Reporting group description
    		 Placebo matching 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: Molnupiravir 400 mg
    Reporting group description
    		 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

    Serious adverse events
    		 Part 1: Molnupiravir 200 mg Part 1: Placebo Part 1: Molnupiravir 800 mg Part 1: Molnupiravir 400 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 73 (15.07%)
    12 / 75 (16.00%)
    13 / 72 (18.06%)
    9 / 73 (12.33%)
         number of deaths (all causes)
    6
    2
    7
    4
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Hypotension
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Physical deconditioning
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    3 / 73 (4.11%)
    2 / 75 (2.67%)
    2 / 72 (2.78%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 73 (4.11%)
    3 / 75 (4.00%)
    3 / 72 (4.17%)
    4 / 73 (5.48%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Gouty arthritis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    2 / 73 (2.74%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    7 / 73 (9.59%)
    6 / 75 (8.00%)
    5 / 72 (6.94%)
    4 / 73 (5.48%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    0 / 2
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 73 (0.00%)
    5 / 75 (6.67%)
    3 / 72 (4.17%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Peritonitis bacterial
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    2 / 72 (2.78%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    2 / 72 (2.78%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    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: Placebo Part 1: Molnupiravir 800 mg Part 1: Molnupiravir 400 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 73 (15.07%)
    13 / 75 (17.33%)
    7 / 72 (9.72%)
    11 / 73 (15.07%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 73 (4.11%)
    3 / 75 (4.00%)
    5 / 72 (6.94%)
    5 / 73 (6.85%)
         occurrences all number
    3
    3
    6
    5
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 73 (5.48%)
    8 / 75 (10.67%)
    7 / 72 (9.72%)
    5 / 73 (6.85%)
         occurrences all number
    4
    8
    7
    5
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    5 / 73 (6.85%)
    5 / 75 (6.67%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    5
    5
    0
    2
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    4 / 73 (5.48%)
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    5 / 73 (6.85%)
         occurrences all number
    4
    1
    0
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2020
    AM1: To revise the dose selection process before initiation of Part 2 (Phase 3), update the benefit/risk assessment, clarify the primary efficacy endpoint definition, and add a new inclusion criterion and discontinuation criterion.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    11 Aug 2021
    This study was terminated early for business reasons.
    -

    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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