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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19

    Summary
    EudraCT number
    		 2021-000904-39
    Trial protocol
    		 ES   HU   BG   RO  
    Global end of trial date
    16 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Nov 2023
    First version publication date
    22 Nov 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    4482-013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04939428
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 jRCT (Japan Registry of Clinical Trials): jRCT2031210281, EudraCT: 2021-000904-39, PHRR: PHRR211007-003980
    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
    16 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study was to assess if the study medication (molnupiravir, MK-4482) would prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who lived with someone with confirmed COVID-19 infection. This was a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants received molnupiravir twice daily by mouth and the other half received a placebo. The primary objectives of the study were to determine if molnupiravir prevented symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who developed COVID-19 during the study were still eligible for any COVID-19 treatment recommended by their doctor.
    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
    11 Aug 2021
    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: 10
    Country: Number of subjects enrolled
    Brazil: 8
    Country: Number of subjects enrolled
    Bulgaria: 73
    Country: Number of subjects enrolled
    Colombia: 214
    Country: Number of subjects enrolled
    Egypt: 74
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Guatemala: 22
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Japan: 22
    Country: Number of subjects enrolled
    Kenya: 5
    Country: Number of subjects enrolled
    Mexico: 161
    Country: Number of subjects enrolled
    Philippines: 21
    Country: Number of subjects enrolled
    Romania: 37
    Country: Number of subjects enrolled
    Russian Federation: 175
    Country: Number of subjects enrolled
    South Africa: 119
    Country: Number of subjects enrolled
    Thailand: 9
    Country: Number of subjects enrolled
    Turkey: 5
    Country: Number of subjects enrolled
    Ukraine: 164
    Country: Number of subjects enrolled
    United States: 409
    Worldwide total number of subjects
    1539
    EEA total number of subjects
    121
    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)
    1416
    From 65 to 84 years
    116
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 Only eligible participants without confirmed or suspected COVID-19 were enrolled within a 5-day period of the index case's first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test result and COVID-19 symptoms onset.

    Pre-assignment
    Screening details
    		 Index cases did not receive study intervention, and only had an optional swab collected at screening for viral testing and SARS-COV2 genetic lineage identification. Baseline characteristics were collected, but no outcome data was gathered.

    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, Assessor
    Blinding implementation details
    Double-blind

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Molnupiravir
    Arm description
    		 Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Molnupiravir
    Investigational medicinal product code
    Other name
    MK-4482-013
    Pharmaceutical forms
    Capsule, Capsule
    Routes of administration
    Oral use, Oral use
    Dosage and administration details
    Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5

    Arm title
    		 Placebo
    Arm description
    		 Participants were given placebo Q12H on Days 1 to 5.
    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
    Participants were given placebo Q12H on Days 1 to 5.

    Number of subjects in period 1
    		Molnupiravir Placebo
    Started
    768
    771
    Treated
    763
    765
    Completed
    750
    751
    Not completed
    18
    20
         Physician decision
    1
    -
         Consent withdrawn by subject
    10
    11
         Randomized By Mistake Without Study Treatment
    1
    -
         Death
    -
    1
         Lost to follow-up
    -
    5
         Unkown
    6
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Molnupiravir
    Reporting group description
    		 Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were given placebo Q12H on Days 1 to 5.

    Reporting group values
    		 Molnupiravir Placebo Total
    Number of subjects
    		 768 771 1539
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 707 709 1416
        From 65-84 years
    		 57 59 116
        85 years and over
    		 4 3 7
    Age Continuous
    Units: years
        median (standard deviation)
    		 37.0 ± 15.6 37.0 ± 15.5 -
    Gender Categorical
    Units: Subjects
        Female
    		 366 342 708
        Male
    		 402 429 831
    Race
    Units: Subjects
        American Indian Or Alaska Native
    		 85 90 175
        Asian
    		 48 40 88
        Black Or African American
    		 62 60 122
        Native Hawaiian Or Other Pacific Islander
    		 1 4 5
        White
    		 453 446 899
        Multiple
    		 119 129 248
        Missing
    		 0 2 2
    Ethnicity
    Units: Subjects
        Hispanic Or Latino
    		 323 340 663
        Not Hispanic Or Latino
    		 445 430 875
        Not Reported
    		 0 1 1
    Stratification Factor at Randomization Collected via IRT: Household Size
    Units: Subjects
        <=3
    		 269 271 540
        >=3
    		 499 500 999
    Stratification Factor at Randomization Collected via IRT: Age Group
    Units: Subjects
        <=60
    		 680 680 1360
        >=60
    		 88 91 179

    End points

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    End points reporting groups
    Reporting group title
    Molnupiravir
    Reporting group description
    		 Participants were treated with molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were given placebo Q12H on Days 1 to 5.

    Primary: Percentage of Participants who Had Undetectable SARS-CoV-2 in Baseline Nasopharyngeal (NP) Swabs and Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14

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    End point title
    		 Percentage of Participants who Had Undetectable SARS-CoV-2 in Baseline Nasopharyngeal (NP) Swabs and Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14
    End point description
    Percentage of participants who had undetectable SARS-CoV-2 in baseline NP swabs and developed COVID-19 (laboratory-confirmed SARS-CoV-2) infection with symptoms) through Day 14. Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Day 14
    End point values
    		 Molnupiravir Placebo
    Number of subjects analysed
    630
    634
    Units: Percentage of Participants
        number (not applicable)
    41
    54
    Statistical analysis title
    		 COVID-19 at Day 14 With no SARS-CoV-2 at Baseline
    Statistical analysis description
    Adjusted differences and the corresponding confidence intervals are based on Miettinen & Nurminen method stratified by age and household size.
    Comparison groups
    Molnupiravir v Placebo
    Number of subjects included in analysis
    1264
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0848
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Confidence Interval
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 0.9

    Primary: Percentage of Participants Discontinuing From Study Therapy due to AE

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    End point title
    		 Percentage of Participants Discontinuing From Study Therapy due to AE
    End point description
    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. Safety Analyses was conducted in the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to 5 days
    End point values
    		 Molnupiravir Placebo
    Number of subjects analysed
    763
    765
    Units: Participants
    3
    1
    Statistical analysis title
    		 Percentage of Participants Discontinued due to AE
    Statistical analysis description
    95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.
    Comparison groups
    Molnupiravir v Placebo
    Number of subjects included in analysis
    1528
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    		 Miettinen & Nurminen method.
    Parameter type
    		 Confidence Interval
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 1
    Notes
    [1] - Estimated differences and confidence intervals are provided

    Primary: Percentage of Participants With ≥1 Adverse Event

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    End point title
    		 Percentage of Participants With ≥1 Adverse Event
    End point description
    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. Safety Analyses was conducted in the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    29 days
    End point values
    		 Molnupiravir Placebo
    Number of subjects analysed
    763
    765
    Units: Participants
    94
    105
    Statistical analysis title
    		 Percentage of Participants with Adverse Events
    Statistical analysis description
    95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.
    Comparison groups
    Molnupiravir v Placebo
    Number of subjects included in analysis
    1528
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Confidence Interval
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 2
    Notes
    [2] - Estimated differences and confidence intervals are provided.

    Secondary: Percentage of Participants (Regardless of SARS-CoV-2 in Baseline NP Swabs) who Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection with Symptoms) Through Day 14

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    End point title
    		 Percentage of Participants (Regardless of SARS-CoV-2 in Baseline NP Swabs) who Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection with Symptoms) Through Day 14
    End point description
    Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Up to Day 14
    End point values
    		 Molnupiravir Placebo
    Number of subjects analysed
    763
    764
    Units: Participants
    78
    103
    Statistical analysis title
    		 COVID-19 Day 14: Regardless Baseline
    Statistical analysis description
    Adjusted differences and the corresponding confidence intervals are based on Miettinen & Nurminen method stratified by age and household size.
    Comparison groups
    Molnupiravir v Placebo
    Number of subjects included in analysis
    1527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0205
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Confidence Interval
    Point estimate
    -3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 -0.1

    Secondary: Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline NP Swabs and Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 29

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    End point title
    		 Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline NP Swabs and Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 29
    End point description
    Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using RT-PCR. The efficacy analysis population was the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 Molnupiravir Placebo
    Number of subjects analysed
    630
    634
    Units: Participants
    51
    65
    Statistical analysis title
    		 COVID-19 at Day 29 With no SARS-CoV-2 at Baseline
    Statistical analysis description
    Adjusted differences and the corresponding confidence intervals are based on Miettinen & Nurminen method stratified by age and household size.
    Comparison groups
    Molnupiravir v Placebo
    Number of subjects included in analysis
    1264
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Confidence Interval
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 1
    Notes
    [3] - Adjusted differences and the corresponding confidence intervals.

    Secondary: Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline NP Swabs and Developed Detectable SARS-CoV-2 in NP Swabs on or Before Day 14

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    End point title
    		 Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline NP Swabs and Developed Detectable SARS-CoV-2 in NP Swabs on or Before Day 14
    End point description
    All participants had NP swabs collected at screening and through Day 14 to test for SARS-CoV-2 using RT-PCR. Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Up to Day 14
    End point values
    		 Molnupiravir Placebo
    Number of subjects analysed
    572
    589
    Units: Participants
    65
    85
    Statistical analysis title
    		 SARS-CoV-2 RNA at Day 14: No Baseline SARS-CoV-2.
    Statistical analysis description
    Adjusted differences and the corresponding confidence intervals are based on Miettinen & Nurminen method stratified by age and household size.
    Comparison groups
    Molnupiravir v Placebo
    Number of subjects included in analysis
    1161
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    Parameter type
    		 Confidence Interval
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 0.8
    Notes
    [4] - Adjusted differences and the corresponding confidence intervals

    Secondary: Percentage of Participants who had Detectable SARS-CoV-2 in Baseline NP Swabs and Developed COVID-19 (laboratory-confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14

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    End point title
    		 Percentage of Participants who had Detectable SARS-CoV-2 in Baseline NP Swabs and Developed COVID-19 (laboratory-confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14
    End point description
    Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using RT-PCR. Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Up to Day 14
    End point values
    		 Molnupiravir Placebo
    Number of subjects analysed
    114
    114
    Units: Participants
    35
    47
    Statistical analysis title
    		 COVID-19 at Day 14 With SARS-CoV-2 in Baseline.
    Statistical analysis description
    Adjusted differences and the corresponding confidence intervals are based on Miettinen & Nurminen method stratified by age and household size.
    Comparison groups
    Molnupiravir v Placebo
    Number of subjects included in analysis
    228
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.7
         upper limit
    		 2
    Notes
    [5] - Adjusted differences and the corresponding confidence intervals.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to Day 29
    Adverse event reporting additional description
    Safety Analyses was conducted in all-participants-as-treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    MK-4482
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events were reported
    Serious adverse events
    		 Placebo MK-4482
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 765 (0.26%)
    3 / 763 (0.39%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 765 (0.00%)
    1 / 763 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 763 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 765 (0.13%)
    2 / 763 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo MK-4482
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 765 (0.00%)
    0 / 763 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Sep 2021
    The key reasons for this amendment were to 1) make the evaluation of laboratory-confirmed COVID-19 through Day 14 in participants with undetectable SARS-CoV-2 in baseline nasopharyngeal (NP) swabs a key secondary endpoint; 2) align the windows (5-days) for COVID-19 symptoms and SARS-CoV-2 testing in the index; and 3) to collect symptom diaries in all participants through Day 29.
    28 Jan 2022
    The primary rationale for this amendment was to revise the primary efficacy objective to include only those participants with undetectable SARS-CoV-2 in baseline nasopharyngeal swabs, and to update the interim analysis to include an assessment of early efficacy. These changes required an increase in the sample size (from 1332 to 1500) and an update of the timing of the interim analysis.
    09 May 2022
    The rationale for this amendment is 1) to add as a secondary objective and associated hypothesis for the prevention of laboratory-confirmed COVID-19 through Day 14 in participants regardless of SARS-CoV-2 results (detectable or undetectable) in baseline NP swabs, and 2) to align male contraception requirements across the study with the requirements in the US EUA Fact Sheet for MOV even if not required locally.
    21 Jun 2022
    The rationale for this amendment is 1) to update the interim analysis to remove the assessment of early efficacy; only safety and futility will be assessed at the interim analysis 2) to revise the power calculation and sample size as a result of removing the assessment of early efficacy at the interim analysis and 3) to correct errors mistakenly introduced in the prior amendment in the third secondary objective and second exploratory objective.
    16 Nov 2022
    The rationale for this amendment is 1) to update the anti-SARS-CoV-2 neutralizing antibody testing method and 2) to allow use of qualitative OP swab data, under extenuating circumstances where NP swab data are not available, for baseline viral status categorization (ie, to establish whether they are in the primary analysis population, mITT-VN) and for clinical outcome assessment.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37690669
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