Coronavirus Disease (COVID-19)
Conditions
Brief 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
Interventions
DRUGMolnupiravir
Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
DRUGPlacebo
Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis) | Up to 29 days | 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. |
| Number of Participants With an Adverse Event (AE) | Up to 318 days | 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. |
| Number of Participants Who Discontinued Study Intervention Due to an AE | Up to 5 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Cough | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Chills | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Headache | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | Up to 29 days | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | Up to 29 days | 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. |
| Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 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. |
| Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 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. |
| Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 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. |
| Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 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. |
| Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 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 to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat | Up to 29 days | 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 to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | Up to 29 days | 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. |
Countries
Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at 123 study centers in 21 countries.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Molnupiravir 200 mg 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 75 |
| Part 1: Molnupiravir 400 mg 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 77 |
| Part 1: Molnupiravir 800 mg 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 76 |
| Part 1: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 74 |
| Part 2: Molnupiravir 800 mg 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 716 |
| Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 717 |
| Total | 1,735 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 1 | 3 | 14 |
| Overall Study | Lost to Follow-up | 2 | 1 | 1 | 2 | 10 | 8 |
| Overall Study | Not Recorded | 0 | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Randomized By Mistake Without Study Treatment | 0 | 0 | 0 | 0 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 4 | 2 | 25 | 28 |
Baseline characteristics
| Characteristic | Part 1: Molnupiravir 400 mg | Total | Part 2: Placebo | Part 2: Molnupiravir 800 mg | Part 1: Placebo | Part 1: Molnupiravir 200 mg | Part 1: Molnupiravir 800 mg |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 14.2 | 45.6 years STANDARD_DEVIATION 14.9 | 45.3 years STANDARD_DEVIATION 15 | 44.4 years STANDARD_DEVIATION 14.6 | 47.3 years STANDARD_DEVIATION 15.2 | 49.5 years STANDARD_DEVIATION 14.6 | 51.0 years STANDARD_DEVIATION 15.8 |
| At Increased Risk of Severe Illness from Coronavirus Disease (COVID-19) (Part 1) No | 19 Participants | 75 Participants | — | — | 18 Participants | 19 Participants | 19 Participants |
| At Increased Risk of Severe Illness from Coronavirus Disease (COVID-19) (Part 1) Yes | 58 Participants | 227 Participants | — | — | 56 Participants | 56 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 826 Participants | 356 Participants | 355 Participants | 33 Participants | 29 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 895 Participants | 358 Participants | 355 Participants | 39 Participants | 46 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 14 Participants | 3 Participants | 6 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 115 Participants | 44 Participants | 60 Participants | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 50 Participants | 23 Participants | 26 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 97 Participants | 35 Participants | 40 Participants | 3 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 443 Participants | 202 Participants | 190 Participants | 13 Participants | 13 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 52 Participants | 1029 Participants | 413 Participants | 400 Participants | 52 Participants | 54 Participants | 58 Participants |
| Sex: Female, Male Female | 32 Participants | 878 Participants | 351 Participants | 384 Participants | 30 Participants | 40 Participants | 41 Participants |
| Sex: Female, Male Male | 45 Participants | 857 Participants | 366 Participants | 332 Participants | 44 Participants | 35 Participants | 35 Participants |
| Time from Symptom Onset to Randomization (Part 1) ≤5 Days | 52 Participants | 205 Participants | — | — | 50 Participants | 51 Participants | 52 Participants |
| Time from Symptom Onset to Randomization (Part 1) >5 Days | 25 Participants | 97 Participants | — | — | 24 Participants | 24 Participants | 24 Participants |
| Time from Symptom Onset to Randomization (Part 2) ≤ 3 days | — | 684 Participants | 342 Participants | 342 Participants | — | — | — |
| Time from Symptom Onset to Randomization (Part 2) > 3 days | — | 749 Participants | 375 Participants | 374 Participants | — | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 77 | 0 / 76 | 1 / 74 | 4 / 716 | 16 / 717 |
| other Total, other adverse events | 6 / 74 | 4 / 77 | 5 / 74 | 9 / 74 | 38 / 710 | 38 / 701 |
| serious Total, serious adverse events | 1 / 74 | 3 / 77 | 4 / 74 | 5 / 74 | 51 / 710 | 67 / 701 |
Outcome results
Primary
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
Population: All randomized participants who received at least one dose of study treatment were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Number of Participants Who Discontinued Study Intervention Due to an AE | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants Who Discontinued Study Intervention Due to an AE | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants Who Discontinued Study Intervention Due to an AE | 3 Participants |
| Part 1: Placebo | Number of Participants Who Discontinued Study Intervention Due to an AE | 1 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants Who Discontinued Study Intervention Due to an AE | 10 Participants |
| Part 2: Placebo | Number of Participants Who Discontinued Study Intervention Due to an AE | 20 Participants |
Primary
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
Population: All randomized participants who received at least one dose of study treatment were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Number of Participants With an Adverse Event (AE) | 29 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With an Adverse Event (AE) | 24 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With an Adverse Event (AE) | 29 Participants |
| Part 1: Placebo | Number of Participants With an Adverse Event (AE) | 28 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With an Adverse Event (AE) | 230 Participants |
| Part 2: Placebo | Number of Participants With an Adverse Event (AE) | 239 Participants |
Primary
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
Population: All randomized participants in Part 1 who received at least one dose of study intervention and were not hospitalized prior to the administration of the first dose of study intervention, and all randomized participants in Part 2 who had reached Day 29 by the pre-specified futility/early efficacy analysis who received at least one dose of study intervention and were not hospitalized prior to the administration of the first dose of study intervention, were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis) | 1.4 Percentage of Participants |
| Part 1: Molnupiravir 400 mg | Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis) | 3.9 Percentage of Participants |
| Part 1: Molnupiravir 800 mg | Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis) | 4.1 Percentage of Participants |
| Part 1: Placebo | Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis) | 5.4 Percentage of Participants |
| Part 2: Molnupiravir 800 mg | Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis) | 7.3 Percentage of Participants |
| Part 2: Placebo | Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis) | 14.1 Percentage of Participants |
95% CI: [-12.2, 2.5]
95% CI: [-9.9, 6.2]
95% CI: [-9.6, 6.4]
p-value: 0.001295% CI: [-11.3, -2.4]Miettinen & Nurminen
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study treatment and had non-missing ordinal scale data at the time point assessed were analyzed. 80 participants with missing ordinal scale data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 6 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 4 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 10 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 8 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 5 | 1 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 1 | 15 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 0 | 9 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 2 | 45 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 3 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 6 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 3 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 4 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 2 | 52 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 10 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 8 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 0 | 11 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 5 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 1 | 8 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 5 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 6 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 1 | 7 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 0 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 2 | 56 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 9 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 3 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 10 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 8 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 4 | 1 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 9 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 0 | 4 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 1 | 13 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 2 | 49 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 3 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 4 | 2 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 5 | 1 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 6 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 7 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 8 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 10 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 7 | 1 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 2 | 519 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 10 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 9 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 8 | 2 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 1 | 68 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 4 | 16 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 0 | 40 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 3 | 12 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 6 | 4 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 5 | 11 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 5 | 21 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 10 | 0 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 7 | 2 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 4 | 23 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 3 | 6 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 8 | 3 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 2 | 493 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 1 | 81 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 9 | 1 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 0 | 32 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 6 | 11 Participants |
95% CI: [0.82, 3.45]
95% CI: [0.55, 2.33]
95% CI: [0.27, 1.29]
95% CI: [1.14, 2.2]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study treatment and had non-missing ordinal scale data at the time point assessed were analyzed. 87 participants with missing ordinal scale data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 6 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 4 | 1 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 10 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 8 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 5 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 1 | 15 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 0 | 20 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 2 | 36 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 3 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 6 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 3 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 4 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 2 | 43 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 10 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 8 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 0 | 21 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 5 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 1 | 8 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 5 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 6 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 1 | 9 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 0 | 13 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 2 | 45 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 9 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 3 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 10 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 8 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 4 | 1 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 9 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 0 | 11 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 1 | 17 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 2 | 39 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 3 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 4 | 2 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 5 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 6 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 7 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 8 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 10 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 7 | 1 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 2 | 433 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 10 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 9 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 8 | 2 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 1 | 110 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 4 | 11 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 0 | 102 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 3 | 5 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 6 | 1 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 5 | 4 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 5 | 12 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 10 | 5 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 7 | 2 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 4 | 21 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 3 | 6 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 8 | 2 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 2 | 427 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 1 | 92 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 9 | 0 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 0 | 94 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 6 | 6 Participants |
95% CI: [0.73, 2.73]
95% CI: [0.52, 1.94]
95% CI: [0.34, 1.32]
95% CI: [1.03, 1.78]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study treatment and had non-missing ordinal scale data at the time point assessed were analyzed. 139 participants with missing ordinal scale data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 6 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 4 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 8 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 10 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 5 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 1 | 14 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 0 | 35 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 2 | 19 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 3 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 8 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 3 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 4 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 10 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 2 | 19 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 0 | 40 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 5 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 1 | 13 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 5 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 6 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 1 | 10 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 0 | 39 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 2 | 15 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 9 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 3 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 10 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 4 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 8 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 9 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 0 | 36 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 1 | 16 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 2 | 14 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 3 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 4 | 1 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 5 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 6 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 7 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 8 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 10 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 7 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 2 | 197 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 10 | 1 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 9 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 8 | 2 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 1 | 126 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 4 | 4 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 0 | 312 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 3 | 1 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 6 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 5 | 2 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 5 | 2 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 10 | 9 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 4 | 10 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 7 | 1 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 3 | 1 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 8 | 0 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 2 | 198 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 1 | 115 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 9 | 0 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 0 | 314 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 6 | 0 Participants |
95% CI: [0.37, 1.81]
95% CI: [0.35, 1.66]
95% CI: [0.38, 1.79]
95% CI: [0.84, 1.29]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study treatment and had non-missing ordinal scale data at the time point assessed were analyzed. 38 participants with missing ordinal scale data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 6 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 4 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 10 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 8 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 5 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 1 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 0 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 2 | 68 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 3 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 3 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 4 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 2 | 72 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 10 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 8 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 0 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 5 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 1 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 5 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 6 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 1 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 0 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 2 | 66 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 9 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 3 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 10 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 8 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 4 | 3 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 9 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 0 | 1 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 1 | 1 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 2 | 66 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 3 | 2 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 4 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 5 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 6 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 7 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 8 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 10 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 7 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 2 | 655 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 10 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 9 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 8 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 1 | 11 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 4 | 7 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 0 | 2 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 3 | 13 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 6 | 3 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 5 | 4 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 5 | 13 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 10 | 0 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 7 | 0 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 4 | 4 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 3 | 10 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 8 | 0 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 2 | 640 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 1 | 13 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 9 | 0 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 0 | 3 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 6 | 1 Participants |
95% CI: [0.59, 15.59]
95% CI: [0.29, 6.16]
95% CI: [0.09, 1.44]
95% CI: [0.62, 2.3]
Secondary
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)
Population: Per protocol, all randomized participants who received at least one dose of study treatment and had non-missing ordinal scale data at the time point assessed were analyzed. 40 participants with missing ordinal scale data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 6 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 4 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 10 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 8 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 5 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 1 | 9 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 0 | 3 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 2 | 58 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 3 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 3 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 4 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 2 | 69 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 10 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 8 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 0 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 5 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 1 | 5 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 5 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 6 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 1 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 0 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 2 | 63 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 9 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 3 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 10 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 8 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 4 | 1 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 9 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 0 | 1 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 1 | 3 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 2 | 65 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 3 | 1 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 4 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 5 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 6 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 7 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 8 | 0 Participants |
| Part 1: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 10 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 7 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 2 | 613 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 10 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 9 | 1 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 8 | 0 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 1 | 36 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 4 | 10 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 0 | 11 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 3 | 14 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 6 | 5 Participants |
| Part 2: Molnupiravir 800 mg | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 5 | 7 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 5 | 21 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 10 | 0 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 7 | 1 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 4 | 13 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 3 | 9 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 8 | 1 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 2 | 593 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 1 | 34 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 9 | 0 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 0 | 10 Participants |
| Part 2: Placebo | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | 6 | 2 Participants |
95% CI: [1.14, 11.88]
95% CI: [0.34, 3.98]
95% CI: [0.27, 2.68]
95% CI: [0.96, 2.39]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (chills) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills | NA Days |
95% CI: [0.3, 2.27]
95% CI: [0.04, 1]
95% CI: [0.23, 1.91]
95% CI: [0.62, 1.23]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (cough) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough | NA Days |
95% CI: [0.29, 2.19]
95% CI: [0.34, 2.44]
95% CI: [0.74, 4.23]
95% CI: [0.67, 1.04]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (diarrhea) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea | NA Days |
95% CI: [0.58, 3.83]
95% CI: [0.42, 3.05]
95% CI: [0.57, 3.93]
95% CI: [0.61, 1.1]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (fatigue) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue | NA Days |
95% CI: [0.26, 1.34]
95% CI: [0.28, 1.37]
95% CI: [0.38, 1.74]
95% CI: [0.79, 1.21]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (feeling hot or feverish) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | NA Days |
95% CI: [0.47, 3.02]
95% CI: [0.29, 2.2]
95% CI: [0.32, 2.45]
95% CI: [0.62, 1.11]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (headache) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache | NA Days |
95% CI: [0.28, 1.2]
95% CI: [0.2, 0.95]
95% CI: [0.43, 1.59]
95% CI: [0.73, 1.19]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (loss of smell) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | NA Days |
95% CI: [0.09, 1.33]
95% CI: [0.3, 2.15]
95% CI: [0.18, 1.48]
95% CI: [0.62, 1.04]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (loss of taste) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | NA Days |
95% CI: [0.11, 1.21]
95% CI: [0.2, 1.36]
95% CI: [0.29, 1.89]
95% CI: [0.68, 1.2]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (muscle or body aches) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches | NA Days |
95% CI: [0.25, 1.39]
95% CI: [0.38, 1.78]
95% CI: [0.25, 1.39]
95% CI: [0.91, 1.48]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (nasal congestion) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | NA Days |
95% CI: [0.46, 3.32]
95% CI: [0.54, 3.74]
95% CI: [0.34, 2.76]
95% CI: [0.66, 1.1]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (nausea) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea | NA Days |
95% CI: [0.35, 2.11]
95% CI: [0.16, 1.34]
95% CI: [0.5, 2.79]
95% CI: [0.74, 1.32]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (rhinorrhea) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | NA Days |
95% CI: [0.41, 2.52]
95% CI: [0.26, 1.9]
95% CI: [0.51, 3]
95% CI: [0.69, 1.17]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (shortness of breath or difficulty breathing) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | NA Days |
95% CI: [0.36, 1.75]
95% CI: [0.33, 1.64]
95% CI: [0.31, 1.62]
95% CI: [0.76, 1.16]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (sore throat) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat | NA Days |
95% CI: [0.98, 6.53]
95% CI: [0.23, 2.52]
95% CI: [0.11, 1.84]
95% CI: [0.66, 1.16]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (vomiting) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting | NA Days |
| Part 1: Molnupiravir 400 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting | NA Days |
| Part 1: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting | NA Days |
| Part 1: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting | NA Days |
| Part 2: Molnupiravir 800 mg | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting | NA Days |
| Part 2: Placebo | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting | NA Days |
95% CI: [0.06, 15.54]
95% CI: [0.06, 15.99]
95% CI: [0.46, 1.25]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (chills) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills | 2.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills | 2.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills | 3.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills | 4.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills | 3.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills | NA Days |
95% CI: [0.77, 2.76]
95% CI: [0.92, 3.38]
95% CI: [0.81, 2.86]
95% CI: [0.89, 1.24]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (cough) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough | 7.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough | 6.5 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough | 8.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough | 6.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough | 10.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough | 10.0 Days |
95% CI: [0.48, 1.13]
95% CI: [0.46, 1.08]
95% CI: [0.47, 1.11]
95% CI: [0.92, 1.18]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (diarrhea) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea | 6.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea | 4.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea | 3.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea | 2.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea | 3.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea | 3.0 Days |
95% CI: [0.06, 0.67]
95% CI: [0.13, 0.83]
95% CI: [0.09, 0.79]
95% CI: [0.87, 1.36]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (fatigue) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue | 7.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue | 5.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue | 6.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue | 6.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue | 6.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue | 7.0 Days |
95% CI: [0.62, 1.41]
95% CI: [0.7, 1.69]
95% CI: [0.66, 1.51]
95% CI: [1.01, 1.31]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (feeling hot or feverish) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | 4.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | 2.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | 4.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | 3.5 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | 3.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | 4.0 Days |
95% CI: [0.54, 1.69]
95% CI: [0.61, 2]
95% CI: [0.5, 1.38]
95% CI: [0.9, 1.21]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (headache) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache | 4.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache | 4.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache | 4.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache | 6.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache | 5.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache | 5.0 Days |
95% CI: [0.81, 2.2]
95% CI: [0.85, 2.31]
95% CI: [0.57, 1.65]
95% CI: [0.89, 1.18]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (loss of smell) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | 7.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | 10.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | 12.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | 12.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | 10.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | 11.0 Days |
95% CI: [0.5, 1.48]
95% CI: [0.83, 2.33]
95% CI: [0.56, 1.72]
95% CI: [1.01, 1.43]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (loss of taste) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | 6.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | 6.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | 10.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | 9.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | 9.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | 10.0 Days |
95% CI: [0.74, 2.23]
95% CI: [0.45, 1.8]
95% CI: [0.55, 1.89]
95% CI: [0.94, 1.37]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (muscles or body aches) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches | 5.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches | 4.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches | 4.5 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches | 4.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches | 4.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches | 5.0 Days |
95% CI: [0.66, 1.61]
95% CI: [0.83, 2.09]
95% CI: [0.47, 1.23]
95% CI: [0.88, 1.16]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (nasal congestion) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | 4.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | 4.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | 8.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | 5.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | 5.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | 6.0 Days |
95% CI: [0.62, 1.46]
95% CI: [0.75, 1.79]
95% CI: [0.45, 1.07]
95% CI: [0.93, 1.23]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (nausea) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea | 5.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea | 3.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea | 6.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea | 5.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea | 4.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea | 4.0 Days |
95% CI: [0.36, 1.91]
95% CI: [0.64, 2.97]
95% CI: [0.37, 2.02]
95% CI: [0.74, 1.14]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (rhinorrhea) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | 4.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | 8.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | 9.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | 5.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | 5.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | 5.0 Days |
95% CI: [0.62, 1.83]
95% CI: [0.4, 1.26]
95% CI: [0.2, 0.85]
95% CI: [0.86, 1.18]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (shortness of breath or difficulty breathing) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | 7.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | 4.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | 9.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | 5.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | 6.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | 9.0 Days |
95% CI: [0.32, 1.34]
95% CI: [0.76, 2.71]
95% CI: [0.39, 1.42]
95% CI: [0.94, 1.37]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (sore throat) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat | 3.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat | 3.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat | 4.5 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat | 5.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat | 4.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat | 5.0 Days |
95% CI: [0.8, 2.76]
95% CI: [0.69, 2.09]
95% CI: [0.54, 1.62]
95% CI: [0.95, 1.33]
Secondary
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
Population: Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (vomiting) at the time of randomization were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting | 4.0 Days |
| Part 1: Molnupiravir 400 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting | 8.0 Days |
| Part 1: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting | 5.0 Days |
| Part 1: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting | 2.0 Days |
| Part 2: Molnupiravir 800 mg | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting | 3.0 Days |
| Part 2: Placebo | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting | NA Days |
95% CI: [0.44, 1.06]
Post Hoc
Percentage 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
Population: All randomized participants in Part 2 who received at least one dose of study intervention and were not hospitalized prior to the administration of the first dose of study intervention were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 | 6.8 Percentage of Participants |
| Part 1: Molnupiravir 400 mg | Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 | 9.7 Percentage of Participants |
95% CI: [-5.9, -0.1]