CompletedNCT04575597Updated Jun 28, 2023Results posted

Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)

A Phase 2/3 interventional study of Molnupiravir and Placebo in Coronavirus Disease (COVID-19), sponsored by Merck Sharp & Dohme LLC. Completed at 173 sites in 23 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-28.

Sponsored by Merck Sharp & Dohme LLC · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 1,735
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29

Conditions studied

Coronavirus Disease (COVID-19)

Browse trials for

COVID-19 7,640

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 1,735 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Has documentation of laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤5 days prior to the day of randomization. PCR is the preferred method; however with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (RNA) or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed.
Had initial onset of signs/symptoms attributable to COVID-19 for ≤5 days prior to the day of randomization and at least 1 of the following sign/symptom attributable to COVID-19 on the day of randomization.
Has mild or moderate COVID-19.
Has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19.
Males agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: Either abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception.
Females are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for at least 4 days after the last dose of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

Exclusion criteria

Exclusion Criteria:

Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization.
Is on dialysis or has reduced estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2 by the Modification of Diet in Renal Disease (MDRD) equation.
Has any of the following conditions: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL (regardless of CD4 count) or an AIDS-defining illness in the past 6 months, participants with HIV may only be enrolled if on a stable antiretroviral therapy regimen; a neutrophilic granulocyte absolute count \<500/mm\^3.
Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening.
Has a platelet count \<100,000/μL or received a platelet transfusion in the 5 days prior to randomization.
Is taking or is anticipated to require any prohibited therapies.
Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics.
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 1,735 participants (actual)

Study arms

Experimental
Part 1: Molnupiravir 200 mg
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Drug: Molnupiravir
Experimental
Part 1: Molnupiravir 400 mg
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Drug: Molnupiravir
Experimental
Part 1: Molnupiravir 800 mg
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Drug: Molnupiravir
Placebo comparator
Part 1: Placebo
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Drug: Placebo
Experimental
Part 2: Molnupiravir 800 mg
800 mg Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Drug: Molnupiravir
Placebo comparator
Part 2: Placebo
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Drug: Placebo

Interventions

DrugMolnupiravir
Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Also known as: MK-4482
DrugPlacebo
Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)

What researchers measure

Primary outcomes

Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis)
The percentage of participants who were hospitalized and/or died through Day 29 is presented. Hospitalization (all cause) is defined as at least 24 hours of acute care in a hospital or similar acute care facility. Death was due to any cause. Any participants with an unknown survival status at Day 29 were treated as failure. The analysis in Part 2 was based on all participants enrolled by the pre-specified futility/early efficacy analysis and was used for demonstration of superiority to placebo for the primary efficacy outcome measure.
Time frame: Up to 29 days
Number of Participants With an Adverse Event (AE)
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.
Time frame: Up to 318 days
Number of Participants Who Discontinued Study Intervention Due to an AE
The number of participants who discontinued study intervention due to an AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 5 days

Secondary outcomes

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell
Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell
Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.
Time frame: Up to 29 days
Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3
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.
Time frame: Day 3
Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5])
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.
Time frame: EOT (Day 5)
Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10
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.
Time frame: Day 10
Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15
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.
Time frame: Day 15
Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29
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.
Time frame: Day 29

Results

Posted Jun 28, 2023

Participant flow

Participants were enrolled at 123 study centers in 21 countries.

Participant flow — Overall Study
Milestone	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Started	75	77	76	74	716	717
Treated	74	77	74	74	710	701
Completed	71	74	71	69	675	663
Not completed	4	3	5	5	41	54
Withdrew: Death	0	0	0	1	3	14
Withdrew: Lost to follow-up	2	1	1	2	10	8
Withdrew: Withdrawal by subject	2	2	4	2	25	28
Withdrew: Not recorded	0	0	0	0	0	2
Withdrew: Randomized by mistake without study treatment	0	0	0	0	3	2

Outcome measures

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

The percentage of participants who were hospitalized and/or died through Day 29 is presented. Hospitalization (all cause) is defined as at least 24 hours of acute care in a hospital or similar acute care facility. Death was due to any cause. Any participants with an unknown survival status at Day 29 were treated as failure. The analysis in Part 2 was based on all participants enrolled by the pre-specified futility/early efficacy analysis and was used for demonstration of superiority to placebo for the primary efficacy outcome measure.

Time frame:: Up to 29 days
Reported as:: Number · Percentage of Participants

Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis)
Percentage of Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis)	1.4	3.9	4.1	5.4	7.3	14.1

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Difference in rates %: -4.1 · 95% CI -12.2 to 2.5
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Difference in rates %: -1.5 · 95% CI -9.9 to 6.2
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Differences in rates %: -1.3 · 95% CI -9.6 to 6.4
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Miettinen & Nurminen · p = 0.0012 · Difference in rates %: -6.8 · 95% CI -11.3 to -2.4

PrimaryNumber of Participants With an Adverse Event (AE)

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.

Time frame:: Up to 318 days
Reported as:: Count of participants · Participants

Number of Participants With an Adverse Event (AE)
Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Number of Participants With an Adverse Event (AE)	29	24	29	28	230	239

PrimaryNumber of Participants Who Discontinued Study Intervention Due to an AE

The number of participants who discontinued study intervention due to an AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame:: Up to 5 days
Reported as:: Count of participants · Participants

Number of Participants Who Discontinued Study Intervention Due to an AE
Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Number of Participants Who Discontinued Study Intervention Due to an AE	0	0	3	1	10	20

SecondaryTime to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough

Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough	7.0 (5.0 to 10.0)	6.5 (4.0 to 10.0)	8.0 (6.0 to 11.0)	6.0 (4.0 to 7.0)	10.0 (9.0 to 11.0)	10.0 (8.0 to 11.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.74 · 95% CI 0.48 to 1.13
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.70 · 95% CI 0.46 to 1.08
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.72 · 95% CI 0.47 to 1.11
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.04 · 95% CI 0.92 to 1.18

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

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat	3.0 (2.0 to 4.0)	3.0 (2.0 to 5.0)	4.5 (3.0 to 8.0)	5.0 (3.0 to 7.0)	4.0 (4.0 to 5.0)	5.0 (5.0 to 6.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 1.49 · 95% CI 0.80 to 2.76
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 1.20 · 95% CI 0.69 to 2.09
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.93 · 95% CI 0.54 to 1.62
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.12 · 95% CI 0.95 to 1.33

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

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion	4.0 (3.0 to 6.0)	4.0 (3.0 to 7.0)	8.0 (5.0 to 10.0)	5.0 (4.0 to 6.0)	5.0 (4.0 to 6.0)	6.0 (5.0 to 7.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.95 · 95% CI 0.62 to 1.46
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 1.16 · 95% CI 0.75 to 1.79
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.69 · 95% CI 0.45 to 1.07
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.07 · 95% CI 0.93 to 1.23

SecondaryTime to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea	4.0 (2.0 to 6.0)	8.0 (5.0 to 10.0)	9.0 (5.0 to 21.0)	5.0 (3.0 to 6.0)	5.0 (4.0 to 6.0)	5.0 (5.0 to 6.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 1.06 · 95% CI 0.62 to 1.83
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.71 · 95% CI 0.40 to 1.26
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.41 · 95% CI 0.20 to 0.85
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.01 · 95% CI 0.86 to 1.18

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

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing	7.0 (4.0 to 22.0)	4.0 (3.0 to 6.0)	9.0 (4.0 to 17.0)	5.0 (4.0 to 12.0)	6.0 (6.0 to 8.0)	9.0 (6.0 to 10.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.66 · 95% CI 0.32 to 1.34
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 1.44 · 95% CI 0.76 to 2.71
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.75 · 95% CI 0.39 to 1.42
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.14 · 95% CI 0.94 to 1.37

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

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches	5.0 (3.0 to 7.0)	4.0 (3.0 to 4.0)	4.5 (3.0 to 15.0)	4.0 (3.0 to 7.0)	4.0 (4.0 to 5.0)	5.0 (4.0 to 5.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 1.03 · 95% CI 0.66 to 1.61
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 1.32 · 95% CI 0.83 to 2.09
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.76 · 95% CI 0.47 to 1.23
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.01 · 95% CI 0.88 to 1.16

SecondaryTime to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue	7.0 (4.0 to 11.0)	5.0 (3.0 to 7.0)	6.0 (4.0 to 11.0)	6.0 (4.0 to 10.0)	6.0 (6.0 to 7.0)	7.0 (6.0 to 8.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.93 · 95% CI 0.62 to 1.41
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 1.09 · 95% CI 0.70 to 1.69
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 1.00 · 95% CI 0.66 to 1.51
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.15 · 95% CI 1.01 to 1.31

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

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish	4.0 (3.0 to 6.0)	2.0 (2.0 to 3.0)	4.0 (3.0 to 5.0)	3.5 (2.0 to 4.0)	3.0 (3.0 to 4.0)	4.0 (3.0 to 4.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.96 · 95% CI 0.54 to 1.69
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 1.10 · 95% CI 0.61 to 2.00
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.83 · 95% CI 0.50 to 1.38
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.04 · 95% CI 0.90 to 1.21

SecondaryTime to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills	2.0 (2.0 to 5.0)	2.0 (2.0 to 4.0)	3.0 (2.0 to 3.0)	4.0 (2.0 to 5.0)	3.0 (2.0 to 3.0)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 1.46 · 95% CI 0.77 to 2.76
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 1.76 · 95% CI 0.92 to 3.38
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 1.52 · 95% CI 0.81 to 2.86
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.05 · 95% CI 0.89 to 1.24

SecondaryTime to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache	4.0 (3.0 to 6.0)	4.0 (3.0 to 7.0)	4.0 (3.0 to 10.0)	6.0 (3.0 to 10.0)	5.0 (4.0 to 5.0)	5.0 (5.0 to 6.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 1.33 · 95% CI 0.81 to 2.20
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 1.40 · 95% CI 0.85 to 2.31
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.97 · 95% CI 0.57 to 1.65
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.02 · 95% CI 0.89 to 1.18

SecondaryTime to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea	5.0 (2.0 to 8.0)	3.0 (2.0 to 4.0)	6.0 (2.0 to 9.0)	5.0 (2.0 to 9.0)	4.0 (3.0 to 5.0)	4.0 (3.0 to 4.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.83 · 95% CI 0.36 to 1.91
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 1.37 · 95% CI 0.64 to 2.97
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.86 · 95% CI 0.37 to 2.02
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.92 · 95% CI 0.74 to 1.14

SecondaryTime to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting	4.0 (2.0 to 6.0)	8.0 (2.0 to 14.0)	5.0 (2.0 to 8.0)	2.0 (2.0 to 4.0)	3.0 (2.0 to 4.0)	NA (NA to NA)

Statistical analysis

Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.68 · 95% CI 0.44 to 1.06

SecondaryTime to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea	6.0 (2.0 to 13.0)	4.0 (2.0 to 4.0)	3.0 (2.0 to 6.0)	2.0 (2.0 to 3.0)	3.0 (3.0 to 4.0)	3.0 (3.0 to 4.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.21 · 95% CI 0.06 to 0.67
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.33 · 95% CI 0.13 to 0.83
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.27 · 95% CI 0.09 to 0.79
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.09 · 95% CI 0.87 to 1.36

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

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste	6.0 (4.0 to 9.0)	6.0 (4.0 to 11.0)	10.0 (4.0 to 19.0)	9.0 (5.0 to 16.0)	9.0 (8.0 to 10.0)	10.0 (8.0 to 12.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 1.29 · 95% CI 0.74 to 2.23
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.90 · 95% CI 0.45 to 1.80
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 1.02 · 95% CI 0.55 to 1.89
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.13 · 95% CI 0.94 to 1.37

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

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell	7.0 (6.0 to 9.0)	10.0 (6.0 to 18.0)	12.0 (6.0 to 19.0)	12.0 (7.0 to 16.0)	10.0 (9.0 to 11.0)	11.0 (9.0 to 14.0)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 1.39 · 95% CI 0.83 to 2.33
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.86 · 95% CI 0.50 to 1.48
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.98 · 95% CI 0.56 to 1.72
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.20 · 95% CI 1.01 to 1.43

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Cough

Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.79 · 95% CI 0.29 to 2.19
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.91 · 95% CI 0.34 to 2.44
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 1.77 · 95% CI 0.74 to 4.23
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.83 · 95% CI 0.67 to 1.04

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 2.52 · 95% CI 0.98 to 6.53
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.77 · 95% CI 0.23 to 2.52
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.46 · 95% CI 0.11 to 1.84
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.88 · 95% CI 0.66 to 1.16

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 1.23 · 95% CI 0.46 to 3.32
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 1.42 · 95% CI 0.54 to 3.74
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.97 · 95% CI 0.34 to 2.76
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.85 · 95% CI 0.66 to 1.10

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 1.02 · 95% CI 0.41 to 2.52
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.71 · 95% CI 0.26 to 1.90
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 1.24 · 95% CI 0.51 to 3.00
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.90 · 95% CI 0.69 to 1.17

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

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.80 · 95% CI 0.36 to 1.75
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.73 · 95% CI 0.33 to 1.64
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.71 · 95% CI 0.31 to 1.62
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.94 · 95% CI 0.76 to 1.16

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.59 · 95% CI 0.25 to 1.39
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.83 · 95% CI 0.38 to 1.78
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.59 · 95% CI 0.25 to 1.39
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 1.16 · 95% CI 0.91 to 1.48

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.59 · 95% CI 0.26 to 1.34
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.62 · 95% CI 0.28 to 1.37
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.82 · 95% CI 0.38 to 1.74
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.96 · 95% CI 0.79 to 1.21

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 1.19 · 95% CI 0.47 to 3.02
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.80 · 95% CI 0.29 to 2.20
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.89 · 95% CI 0.32 to 2.45
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.83 · 95% CI 0.62 to 1.11

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Chills

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.82 · 95% CI 0.30 to 2.27
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.21 · 95% CI 0.04 to 1.00
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.66 · 95% CI 0.23 to 1.91
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.87 · 95% CI 0.62 to 1.23

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Headache

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.58 · 95% CI 0.28 to 1.20
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.44 · 95% CI 0.20 to 0.95
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.82 · 95% CI 0.43 to 1.59
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.93 · 95% CI 0.73 to 1.19

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.86 · 95% CI 0.35 to 2.11
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.46 · 95% CI 0.16 to 1.34
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 1.18 · 95% CI 0.50 to 2.79
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.99 · 95% CI 0.74 to 1.32

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.97 · 95% CI 0.06 to 15.54
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.00
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 1.00 · 95% CI 0.06 to 15.99
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.76 · 95% CI 0.46 to 1.25

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 1.49 · 95% CI 0.58 to 3.83
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 1.14 · 95% CI 0.42 to 3.05
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 1.49 · 95% CI 0.57 to 3.93
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.82 · 95% CI 0.61 to 1.10

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.36 · 95% CI 0.11 to 1.21
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.52 · 95% CI 0.20 to 1.36
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.74 · 95% CI 0.29 to 1.89
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.91 · 95% CI 0.68 to 1.20

SecondaryTime to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell

Time frame:: Up to 29 days
Reported as:: Median · Days

Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell
Days	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Hazard ratio (hr): 0.35 · 95% CI 0.09 to 1.33
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Hazard ratio (hr): 0.80 · 95% CI 0.30 to 2.15
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Hazard ratio (hr): 0.51 · 95% CI 0.18 to 1.48
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Hazard ratio (hr): 0.81 · 95% CI 0.62 to 1.04

SecondaryNumber of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3

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.

Time frame:: Day 3
Reported as:: Count of participants · Participants

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3
Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	2	0	0	1	2	3
1	2	2	1	1	11	13
2	68	72	66	66	655	640
3	0	0	2	2	13	10
4	0	1	3	0	7	4
5	0	0	1	0	4	13
6	0	0	0	0	3	1
7	0	0	0	0	0	0
8	0	0	0	0	0	0
9	0	0	0	0	0	0
10	0	0	0	0	0	0

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Odds ratio (or): 3.04 · 95% CI 0.59 to 15.59
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Odds ratio (or): 1.33 · 95% CI 0.29 to 6.16
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Odds ratio (or): 0.37 · 95% CI 0.09 to 1.44
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Odds ratio (or): 1.19 · 95% CI 0.62 to 2.30

SecondaryNumber of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5])

Time frame:: EOT (Day 5)
Reported as:: Count of participants · Participants

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5])
Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	3	0	2	1	11	10
1	9	5	3	3	36	34
2	58	69	63	65	613	593
3	0	0	0	1	14	9
4	0	0	1	0	10	13
5	0	1	1	0	7	21
6	0	0	0	0	5	2
7	0	0	0	0	0	1
8	0	0	1	0	0	1
9	0	0	0	0	1	0
10	0	0	0	0	0	0

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Odds ratio (or): 3.67 · 95% CI 1.14 to 11.88
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Odds ratio (or): 1.16 · 95% CI 0.34 to 3.98
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Odds ratio (or): 0.85 · 95% CI 0.27 to 2.68
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Odds ratio (or): 1.52 · 95% CI 0.96 to 2.39

SecondaryNumber of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10

Time frame:: Day 10
Reported as:: Count of participants · Participants

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10
Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	9	11	3	4	40	32
1	15	8	7	13	68	81
2	45	52	56	49	519	493
3	0	0	0	0	12	6
4	0	0	1	2	16	23
5	1	1	1	1	11	21
6	0	1	0	0	4	11
7	0	0	0	0	1	2
8	0	0	1	0	2	3
9	0	0	0	0	0	1
10	0	0	0	0	0	0

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Odds ratio (or): 1.68 · 95% CI 0.82 to 3.45
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Odds ratio (or): 1.13 · 95% CI 0.55 to 2.33
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Odds ratio (or): 0.59 · 95% CI 0.27 to 1.29
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Odds ratio (or): 1.58 · 95% CI 1.14 to 2.20

SecondaryNumber of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15

Time frame:: Day 15
Reported as:: Count of participants · Participants

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15
Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	20	21	13	11	102	94
1	15	8	9	17	110	92
2	36	43	45	39	433	427
3	0	0	0	0	5	6
4	1	0	1	2	11	21
5	0	0	1	0	4	12
6	0	1	0	0	1	6
7	0	0	0	0	1	2
8	0	0	1	0	2	2
9	0	0	0	0	0	0
10	0	0	0	0	0	5

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Odds ratio (or): 1.41 · 95% CI 0.73 to 2.73
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Odds ratio (or): 1.00 · 95% CI 0.52 to 1.94
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Odds ratio (or): 0.67 · 95% CI 0.34 to 1.32
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Odds ratio (or): 1.36 · 95% CI 1.03 to 1.78

SecondaryNumber of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29

Time frame:: Day 29
Reported as:: Count of participants · Participants

Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29
Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	35	40	39	36	312	314
1	14	13	10	16	126	115
2	19	19	15	14	197	198
3	0	0	0	0	1	1
4	0	0	2	1	4	10
5	0	0	0	0	2	2
6	0	0	0	0	0	0
7	0	0	0	0	0	1
8	0	0	0	0	2	0
9	0	0	0	0	0	0
10	0	0	0	0	1	9

Statistical analysis

Part 1: Molnupiravir 200 mg vs Part 1: Placebo · Odds ratio (or): 0.76 · 95% CI 0.35 to 1.66
Part 1: Molnupiravir 400 mg vs Part 1: Placebo · Odds ratio (or): 0.82 · 95% CI 0.38 to 1.79
Part 1: Molnupiravir 800 mg vs Part 1: Placebo · Odds ratio (or): 0.82 · 95% CI 0.37 to 1.81
Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Odds ratio (or): 1.04 · 95% CI 0.84 to 1.29

Post-hocPercentage of Participants Who Were Hospitalized and/or Died Through Day 29

The percentage of participants who were hospitalized and/or died through Day 29 is presented. Hospitalization (all cause) is defined as at least 24 hours of acute care in a hospital or similar acute care facility. Death was due to any cause. Any participants with an unknown survival status at Day 29 were treated as failure. This analysis was based on all randomized participants in Part 2 who received at least one dose of study treatment, were not hospitalized prior to the administration of the first dose of study intervention, and had reached Day 29 post treatment.

Time frame:: Up to 29 days
Reported as:: Number · Percentage of Participants

Percentage of Participants Who Were Hospitalized and/or Died Through Day 29
Percentage of Participants	Part 2: Molnupiravir 800 mg	Part 2: Placebo
Percentage of Participants Who Were Hospitalized and/or Died Through Day 29	6.8	9.7

Statistical analysis

Part 2: Molnupiravir 800 mg vs Part 2: Placebo · Difference in rates %: -3.0 · 95% CI -5.9 to -0.1

Adverse events

Collected over Up to 318 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1: MK-4482 200 mg	0/75 (0%)	1/74 (1.4%)	6/74 (8.1%)
Part 1: MK-4482 400 mg	0/77 (0%)	3/77 (3.9%)	4/77 (5.2%)
Part 1: MK-4482 800 mg	0/76 (0%)	4/74 (5.4%)	5/74 (6.8%)
Part 1: Placebo	1/74 (1.4%)	5/74 (6.8%)	9/74 (12.2%)
Part 2: MK-4482 800 mg	4/716 (0.6%)	51/710 (7.2%)	38/710 (5.4%)
Part 2: Placebo	16/717 (2.2%)	67/701 (9.6%)	38/701 (5.4%)

Most frequent serious events

Showing 10 of 38

Most frequent serious events
Event	Part 1: MK-4482 200 mg	Part 1: MK-4482 400 mg	Part 1: MK-4482 800 mg	Part 1: Placebo	Part 2: MK-4482 800 mg	Part 2: Placebo
COVID-19Infections and infestations	0/74	1/77	2/74	1/74	37/710	53/701
COVID-19 pneumoniaInfections and infestations	1/74	2/77	2/74	2/74	29/710	43/701
PneumoniaInfections and infestations	0/74	0/77	1/74	0/74	2/710	0/701
Diabetic metabolic decompensationMetabolism and nutrition disorders	0/74	0/77	0/74	1/74	0/710	1/701
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	0/74	1/77	0/74	1/74	1/710	1/701
Peripheral vascular disorderVascular disorders	0/74	0/77	0/74	1/74	0/710	0/701
Thrombosis mesenteric vesselGastrointestinal disorders	0/74	0/77	0/74	1/74	0/710	0/701
Respiratory failureRespiratory, thoracic and mediastinal disorders	0/74	0/77	0/74	0/74	6/710	9/701
Pneumonia bacterialInfections and infestations	0/74	0/77	0/74	0/74	3/710	2/701
Acute respiratory failureRespiratory, thoracic and mediastinal disorders	0/74	0/77	0/74	0/74	0/710	2/701

Most frequent other events

Most frequent other events
Event	Part 1: MK-4482 200 mg	Part 1: MK-4482 400 mg	Part 1: MK-4482 800 mg	Part 1: Placebo	Part 2: MK-4482 800 mg	Part 2: Placebo
COVID-19Infections and infestations	3/74	2/77	3/74	5/74	23/710	17/701
DiarrhoeaGastrointestinal disorders	3/74	2/77	2/74	4/74	16/710	21/701

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo	Total
Mean	49.5 ± 14.6	49.2 ± 14.2	51.0 ± 15.8	47.3 ± 15.2	44.4 ± 14.6	45.3 ± 15.0	45.6 ± 14.9

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo	Total
Female	40	32	41	30	384	351	878
Male	35	45	35	44	332	366	857

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo	Total
Hispanic or Latino	29	30	23	33	355	356	826
Not Hispanic or Latino	46	46	51	39	355	358	895
Unknown or Not Reported	0	1	2	2	6	3	14

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo	Total
American Indian or Alaska Native	3	1	2	5	60	44	115
Asian	0	1	0	0	26	23	50
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Black or African American	5	8	6	3	40	35	97
White	54	52	58	52	400	413	1029
More than one race	13	15	10	13	190	202	443
Unknown or Not Reported	0	0	0	1	0	0	1

Time from Symptom Onset to Randomization (Part 1)
Time from Symptom Onset to Randomization (Part 1)(Participants)	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo	Total
≤5 Days	51	52	52	50	—	—	205
>5 Days	24	25	24	24	—	—	97

At Increased Risk of Severe Illness from Coronavirus Disease (COVID-19) (Part 1)
At Increased Risk of Severe Illness from Coronavirus Disease (COVID-19) (Part 1)(Participants)	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo	Total
Yes	56	58	57	56	—	—	227
No	19	19	19	18	—	—	75

Time from Symptom Onset to Randomization (Part 2)
Time from Symptom Onset to Randomization (Part 2)(Participants)	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo	Total
≤ 3 days	—	—	—	—	342	342	684
> 3 days	—	—	—	—	374	375	749

Study locations

173 sites

Phoenix Medical Group ( Site 1822)
Peoria, Arizona 85381, United States
Ruane Clinical Research Group, Inc. ( Site 2406)
Los Angeles, California 90036, United States
Men's Health Foundation ( Site 1820)
Los Angeles, California 90069, United States
Carbon Health Technologies Inc ( Site 2505)
North Hollywood, California 91606, United States
UC Davis Medical Center ( Site 1833)
Sacramento, California 95817, United States
Emerson Clinical Research Institute ( Site 1828)
Washington, District of Columbia 20011, United States
JEM Research Institute ( Site 2508)
Atlantis, Florida 33462, United States
Midway Immunology and Research Center ( Site 1837)
Fort Pierce, Florida 34982, United States
Indago Research & Health Center, Inc ( Site 1809)
Hialeah, Florida 33012, United States
Advanced Research For Health Improvement LLC ( Site 1816)
Immokalee, Florida 34142, United States
Advanced Medical Research, LLC ( Site 1864)
Miami, Florida 33174, United States
Advanced Research For Health Improvement LLC ( Site 1813)
Naples, Florida 34102, United States
Bliss Healthcare Services ( Site 1847)
Orlando, Florida 32806, United States
Javara Inc. ( Site 1869)
Albany, Georgia 31707, United States
IACT Health ( Site 1818)
Columbus, Georgia 31904, United States
Javara Inc. ( Site 1868)
Fayetteville, Georgia 30214, United States
Loretto Hospital ( Site 1886)
Chicago, Illinois 60644, United States
Jadestone Clinical Research, LLC ( Site 2502)
Laurel, Maryland 20708, United States
Michigan Center of Medical Research ( Site 2500)
Farmington Hills, Michigan 48334, United States
University of Nebraska Medical Center ( Site 2414)
Omaha, Nebraska 68198, United States
Amici Clinical Research LLC ( Site 2507)
Raritan, New Jersey 08869, United States
University of New Mexico, Health Sciences Center ( Site 1819)
Albuquerque, New Mexico 87131, United States
AXCES Research Group ( Site 2418)
Santa Fe, New Mexico 87505, United States
Saint Hope Foundation, Inc. ( Site 1830)
Bellaire, Texas 77401, United States
The Crofoot Research Center, Inc. ( Site 1812)
Houston, Texas 77098, United States
Javara Inc. ( Site 1866)
Sugar Land, Texas 77478, United States
Clinical Research Partners, LLC. ( Site 2503)
Richmond, Virginia 23226, United States
Swedish Medical Center First Hill ( Site 1807)
Seattle, Washington 98104, United States
Fred Hutchinson Cancer Center ( Site 1829)
Seattle, Washington 98109, United States
Multicare Health System ( Site 1811)
Spokane, Washington 99204, United States
Multicare Health System ( Site 1814)
University Place, Washington 98466, United States
Medical College Of Wisconsin ( Site 2510)
Milwaukee, Wisconsin 53226, United States
Clinica Independencia ( Site 3400)
Vicente Lopez, Buenos Aires B1605FRE, Argentina
Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)
Rosario, Santa Fe 2000, Argentina
Chronos Pesquisa Clínica ( Site 0155)
Brasilia, Distrito Federal 72145-424, Brazil
Santa Casa de Misericordia de Belo Horizonte ( Site 0150)
Belo Horizonte, Minas Gerais 30150-221, Brazil
Hospital de Clinicas da Universidade Federal do Parana ( Site 0154)
Curitiba, Parana 80060-900, Brazil
Hospital Tacchini ( Site 0157)
Bento Goncalves, Rio Grande Do Sul 95700-000, Brazil
FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151)
Sao Jose do Rio Preto, Sao Paulo 15090-000, Brazil
Instituto de Infectologia Emilio Ribas ( Site 0153)
Sao Paulo, 01246-900, Brazil
Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152)
Sao Paulo, 05403-010, Brazil
Hamilton Medical Research Group ( Site 0207)
Hamilton, Ontario L8M1K7, Canada
University Health Network - Toronto General Hospital ( Site 0201)
Toronto, Ontario M5G 2N2, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)
Montreal, Quebec H2X 3E4, Canada
McGill University Health Centre ( Site 0204)
Montreal, Quebec H4A 3J1, Canada
Servicios Medicos Urumed ( Site 0307)
Rancagua, Lbtdr Gen Bernardo O Higgins 2852424, Chile
Clinical Research Chile SpA ( Site 0308)
Valdivia, Los Rios 5110683, Chile
Clinica Universidad de los Andes ( Site 0302)
Santiago, Region M. De Santiago 2820945, Chile
Fundacion Arturo Lopez Perez ( Site 0305)
Santiago, Region M. De Santiago 7500921, Chile
Espacio EME ( Site 0304)
Santiago, Region M. De Santiago 7770086, Chile
Centro de Investigacion Clinica UC CICUC ( Site 0309)
Santiago, Region M. De Santiago 8330034, Chile
Clinica Bicentenario Spa ( Site 0306)
Santiago, Region M. De Santiago 9160000, Chile
Hospital Pablo Tobon Uribe ( Site 0405)
Medellin, Antioquia 050034, Colombia
Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)
Barranquilla, Atlantico 080020, Colombia
Clinica de la Costa Ltda. ( Site 0403)
Barranquilla, Atlantico 080020, Colombia
Oncomedica S.A. ( Site 0407)
Monteria, Cordoba 230002, Colombia
Caja de Compensación Familiar CAFAM. Sede Centro de Atención en Salud CAFAM Floresta ( Site 0406)
Bogota, Cundinamarca 111211, Colombia
Centro de Atencion e Investigacion Medica CAIMED ( Site 0413)
Bogota, Cundinamarca 111611, Colombia
Fundacion Santa Fe de Bogota ( Site 0412)
Bogota, Distrito Capital De Bogota 110111, Colombia
Fundacion Cardiovascular de Colombia ( Site 0402)
Bucaramanca, Santander 680003, Colombia
Fundacion Valle del Lili ( Site 0401)
Cali, Valle Del Cauca 760032, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0415)
Cali, Valle Del Cauca 760042, Colombia
National Center for allergies and chest ( Site 3320)
Giza, Al Jizah 12651, Egypt
National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300)
Cairo, Al Qahirah 11562, Egypt
Abbassia Chest Hospital ( Site 3340)
Cairo, Al Qahirah 11591, Egypt
Abbassia Fever Hospital ( Site 3330)
Cairo, Al Qahirah 11591, Egypt
Helwan Fever Hospital ( Site 3350)
Cairo, Al Qahirah 12899, Egypt
Hopital Bichat Claude Bernard ( Site 0503)
Paris, Ain 75018, France
Hopital Saint Joseph ( Site 0513)
Marseille, Bouches-du-Rhone 13285, France
Groupe Hospitalier Pellegrin ( Site 0511)
Bordeaux, Gironde 33000, France
CHU de la Reunion - Groupe Hospitalier Sud ( Site 0514)
Saint Pierre Cedex, La Reunion 97448, France
C.H.U. de Toulouse Hopital Purpan ( Site 0501)
Toulouse, Midi-Pyrenees 31059, France
Centre Hospitalier de Tourcoing ( Site 0502)
Tourcoing, Nord 59208, France
CHU Hopital Saint Antoine ( Site 0505)
Paris, 75012, France
Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)
Paris, 75013, France
Universitaetsklinikum Frankfurt ( Site 2302)
Frankfurt a main, Hessen 60590, Germany
Universitaetsklinikum Essen ( Site 2305)
Essen, Nordrhein-Westfalen 45147, Germany
ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301)
Berlin, 10439, Germany
ICH Study Center GmbH & Co.KG ( Site 2306)
Hamburg, 20146, Germany
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 2601)
Guatemala, 01009, Guatemala
Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2600)
Guatemala, 01015, Guatemala
Hadassah Medical Center. Ein Kerem ( Site 2100)
Jerusalem, 9112001, Israel
Asl Napoli 1 Centro ( Site 0610)
Napoles, Napoli 80145, Italy
Policlinico S. Orsola-Malpighi ( Site 0604)
Bologna, 40138, Italy
IRCCS Ospedale Policlinico San Martino ( Site 0603)
Genova, 16132, Italy
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606)
Milano, 20122, Italy
Ospedale San Raffaele ( Site 0605)
Milano, 20127, Italy
ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)
Milano, 20157, Italy
Ospedale Niguarda ( Site 0608)
Milano, 20162, Italy
AOU Policlinico Paolo Giaccone ( Site 0609)
Palermo, 90127, Italy
Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 0600)
Roma, 00149, Italy
Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602)
Torino, 10149, Italy
Azienda Sanitaria Universitaria Friuli Centrale -ASU FC ( Site 0607)
Udine, 33100, Italy
Chiba Aoba Municipal Hospital ( Site 0702)
Chiba, 260-0852, Japan
Den-en-chofu family clinic ( Site 0701)
Tokyo, 145-0071, Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 0700)
Tokyo, 162-8655, Japan
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)
Ciudad de mexico, Distrito Federal 14080, Mexico
CAIMED México ( Site 0814)
Mexico City, Distrito Federal 06760, Mexico
Hospital Regional de Alta Especialidad del Bajio ( Site 0807)
Leon, Guanajuato 37660, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)
Guadalajara, Jalisco 44280, Mexico

Showing the first 100 of 173 sites across 23 countries.

References and documents

Publications

Caraco Y, Crofoot GE, Moncada PA, Galustyan AN, Musungaie DB, Payne B, Kovalchuk E, Gonzalez A, Brown ML, Williams-Diaz A, Gao W, Strizki JM, Grobler J, Du J, Assaid CA, Paschke A, Butterton JR, Johnson MG, De Anda C. Phase 2/3 Trial of Molnupiravir for Treatment of Covid-19 in Nonhospitalized Adults. NEJM Evid. 2022 Feb;1(2):EVIDoa2100043. doi: 10.1056/EVIDoa2100043. Epub 2021 Dec 16. PubMed 38319179 ↗
Johnson MG, Puenpatom A, Moncada PA, Burgess L, Duke ER, Ohmagari N, Wolf T, Bassetti M, Bhagani S, Ghosn J, Zhang Y, Wan H, Williams-Diaz A, Brown ML, Paschke A, De Anda C. Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 : A Randomized, Placebo-Controlled Trial. Ann Intern Med. 2022 Aug;175(8):1126-1134. doi: 10.7326/M22-0729. Epub 2022 Jun 7. PubMed 35667065 ↗
Jayk Bernal A, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, Martin-Quiros A, Caraco Y, Williams-Diaz A, Brown ML, Du J, Pedley A, Assaid C, Strizki J, Grobler JA, Shamsuddin HH, Tipping R, Wan H, Paschke A, Butterton JR, Johnson MG, De Anda C; MOVe-OUT Study Group. Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med. 2022 Feb 10;386(6):509-520. doi: 10.1056/NEJMoa2116044. Epub 2021 Dec 16. PubMed 34914868 ↗

Study documents

Protocol and statistical analysis plan · Aug 15, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04575597
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Oct 5, 2020
Start date: Oct 19, 2020
Primary completion: May 5, 2022
Completion: May 5, 2022
Results posted: Jun 28, 2023
Last update: Jun 28, 2023

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	2	0	0	1	2	3
1	2	2	1	1	11	13
2	68	72	66	66	655	640
3	0	0	2	2	13	10
4	0	1	3	0	7	4
5	0	0	1	0	4	13
6	0	0	0	0	3	1
7	0	0	0	0	0	0
8	0	0	0	0	0	0
9	0	0	0	0	0	0
10	0	0	0	0	0	0

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	3	0	2	1	11	10
1	9	5	3	3	36	34
2	58	69	63	65	613	593
3	0	0	0	1	14	9
4	0	0	1	0	10	13
5	0	1	1	0	7	21
6	0	0	0	0	5	2
7	0	0	0	0	0	1
8	0	0	1	0	0	1
9	0	0	0	0	1	0
10	0	0	0	0	0	0

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	9	11	3	4	40	32
1	15	8	7	13	68	81
2	45	52	56	49	519	493
3	0	0	0	0	12	6
4	0	0	1	2	16	23
5	1	1	1	1	11	21
6	0	1	0	0	4	11
7	0	0	0	0	1	2
8	0	0	1	0	2	3
9	0	0	0	0	0	1
10	0	0	0	0	0	0

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	20	21	13	11	102	94
1	15	8	9	17	110	92
2	36	43	45	39	433	427
3	0	0	0	0	5	6
4	1	0	1	2	11	21
5	0	0	1	0	4	12
6	0	1	0	0	1	6
7	0	0	0	0	1	2
8	0	0	1	0	2	2
9	0	0	0	0	0	0
10	0	0	0	0	0	5

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	35	40	39	36	312	314
1	14	13	10	16	126	115
2	19	19	15	14	197	198
3	0	0	0	0	1	1
4	0	0	2	1	4	10
5	0	0	0	0	2	2
6	0	0	0	0	0	0
7	0	0	0	0	0	1
8	0	0	0	0	2	0
9	0	0	0	0	0	0
10	0	0	0	0	1	9

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	2	0	0	1	2	3
1	2	2	1	1	11	13
2	68	72	66	66	655	640
3	0	0	2	2	13	10
4	0	1	3	0	7	4
5	0	0	1	0	4	13
6	0	0	0	0	3	1
7	0	0	0	0	0	0
8	0	0	0	0	0	0
9	0	0	0	0	0	0
10	0	0	0	0	0	0

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	3	0	2	1	11	10
1	9	5	3	3	36	34
2	58	69	63	65	613	593
3	0	0	0	1	14	9
4	0	0	1	0	10	13
5	0	1	1	0	7	21
6	0	0	0	0	5	2
7	0	0	0	0	0	1
8	0	0	1	0	0	1
9	0	0	0	0	1	0
10	0	0	0	0	0	0

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	9	11	3	4	40	32
1	15	8	7	13	68	81
2	45	52	56	49	519	493
3	0	0	0	0	12	6
4	0	0	1	2	16	23
5	1	1	1	1	11	21
6	0	1	0	0	4	11
7	0	0	0	0	1	2
8	0	0	1	0	2	3
9	0	0	0	0	0	1
10	0	0	0	0	0	0

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	20	21	13	11	102	94
1	15	8	9	17	110	92
2	36	43	45	39	433	427
3	0	0	0	0	5	6
4	1	0	1	2	11	21
5	0	0	1	0	4	12
6	0	1	0	0	1	6
7	0	0	0	0	1	2
8	0	0	1	0	2	2
9	0	0	0	0	0	0
10	0	0	0	0	0	5

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	35	40	39	36	312	314
1	14	13	10	16	126	115
2	19	19	15	14	197	198
3	0	0	0	0	1	1
4	0	0	2	1	4	10
5	0	0	0	0	2	2
6	0	0	0	0	0	0
7	0	0	0	0	0	1
8	0	0	0	0	2	0
9	0	0	0	0	0	0
10	0	0	0	0	1	9

Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)

Study summary

Conditions studied

Browse trials for

In context

COVID-19

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	2	0	0	1	2	3
1	2	2	1	1	11	13
2	68	72	66	66	655	640
3	0	0	2	2	13	10
4	0	1	3	0	7	4
5	0	0	1	0	4	13
6	0	0	0	0	3	1
7	0	0	0	0	0	0
8	0	0	0	0	0	0
9	0	0	0	0	0	0
10	0	0	0	0	0	0

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	3	0	2	1	11	10
1	9	5	3	3	36	34
2	58	69	63	65	613	593
3	0	0	0	1	14	9
4	0	0	1	0	10	13
5	0	1	1	0	7	21
6	0	0	0	0	5	2
7	0	0	0	0	0	1
8	0	0	1	0	0	1
9	0	0	0	0	1	0
10	0	0	0	0	0	0

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	9	11	3	4	40	32
1	15	8	7	13	68	81
2	45	52	56	49	519	493
3	0	0	0	0	12	6
4	0	0	1	2	16	23
5	1	1	1	1	11	21
6	0	1	0	0	4	11
7	0	0	0	0	1	2
8	0	0	1	0	2	3
9	0	0	0	0	0	1
10	0	0	0	0	0	0

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	20	21	13	11	102	94
1	15	8	9	17	110	92
2	36	43	45	39	433	427
3	0	0	0	0	5	6
4	1	0	1	2	11	21
5	0	0	1	0	4	12
6	0	1	0	0	1	6
7	0	0	0	0	1	2
8	0	0	1	0	2	2
9	0	0	0	0	0	0
10	0	0	0	0	0	5

Participants	Part 1: Molnupiravir 200 mg	Part 1: Molnupiravir 400 mg	Part 1: Molnupiravir 800 mg	Part 1: Placebo	Part 2: Molnupiravir 800 mg	Part 2: Placebo
0	35	40	39	36	312	314
1	14	13	10	16	126	115
2	19	19	15	14	197	198
3	0	0	0	0	1	1
4	0	0	2	1	4	10
5	0	0	0	0	2	2
6	0	0	0	0	0	0
7	0	0	0	0	0	1
8	0	0	0	0	2	0
9	0	0	0	0	0	0
10	0	0	0	0	1	9