Trial Outcomes & Findings for Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002) (NCT NCT04575597)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

1735 participants

Primary outcome timeframe

Up to 29 days

Results posted on

2023-06-28

Participant Flow

Participants were enrolled at 123 study centers in 21 countries.

Participant milestones

Participant milestones
Measure	Part 1: Molnupiravir 200 mg 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Study STARTED	75	77	76	74	716	717
Overall Study Treated	74	77	74	74	710	701
Overall Study COMPLETED	71	74	71	69	675	663
Overall Study NOT COMPLETED	4	3	5	5	41	54

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Molnupiravir 200 mg 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Study Death	0	0	0	1	3	14
Overall Study Lost to Follow-up	2	1	1	2	10	8
Overall Study Withdrawal by Subject	2	2	4	2	25	28
Overall Study Not Recorded	0	0	0	0	0	2
Overall Study Randomized By Mistake Without Study Treatment	0	0	0	0	3	2

Baseline Characteristics

Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Molnupiravir 200 mg n=75 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=77 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=76 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=74 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=716 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=717 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Total n=1735 Participants Total of all reporting groups
Age, Continuous	49.5 years STANDARD_DEVIATION 14.6 • n=75 Participants	49.2 years STANDARD_DEVIATION 14.2 • n=77 Participants	51.0 years STANDARD_DEVIATION 15.8 • n=76 Participants	47.3 years STANDARD_DEVIATION 15.2 • n=74 Participants	44.4 years STANDARD_DEVIATION 14.6 • n=716 Participants	45.3 years STANDARD_DEVIATION 15.0 • n=717 Participants	45.6 years STANDARD_DEVIATION 14.9 • n=1735 Participants
Sex: Female, Male Female	40 Participants n=75 Participants	32 Participants n=77 Participants	41 Participants n=76 Participants	30 Participants n=74 Participants	384 Participants n=716 Participants	351 Participants n=717 Participants	878 Participants n=1735 Participants
Sex: Female, Male Male	35 Participants n=75 Participants	45 Participants n=77 Participants	35 Participants n=76 Participants	44 Participants n=74 Participants	332 Participants n=716 Participants	366 Participants n=717 Participants	857 Participants n=1735 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=75 Participants	30 Participants n=77 Participants	23 Participants n=76 Participants	33 Participants n=74 Participants	355 Participants n=716 Participants	356 Participants n=717 Participants	826 Participants n=1735 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=75 Participants	46 Participants n=77 Participants	51 Participants n=76 Participants	39 Participants n=74 Participants	355 Participants n=716 Participants	358 Participants n=717 Participants	895 Participants n=1735 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=75 Participants	1 Participants n=77 Participants	2 Participants n=76 Participants	2 Participants n=74 Participants	6 Participants n=716 Participants	3 Participants n=717 Participants	14 Participants n=1735 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=75 Participants	1 Participants n=77 Participants	2 Participants n=76 Participants	5 Participants n=74 Participants	60 Participants n=716 Participants	44 Participants n=717 Participants	115 Participants n=1735 Participants
Race (NIH/OMB) Asian	0 Participants n=75 Participants	1 Participants n=77 Participants	0 Participants n=76 Participants	0 Participants n=74 Participants	26 Participants n=716 Participants	23 Participants n=717 Participants	50 Participants n=1735 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=75 Participants	0 Participants n=77 Participants	0 Participants n=76 Participants	0 Participants n=74 Participants	0 Participants n=716 Participants	0 Participants n=717 Participants	0 Participants n=1735 Participants
Race (NIH/OMB) Black or African American	5 Participants n=75 Participants	8 Participants n=77 Participants	6 Participants n=76 Participants	3 Participants n=74 Participants	40 Participants n=716 Participants	35 Participants n=717 Participants	97 Participants n=1735 Participants
Race (NIH/OMB) White	54 Participants n=75 Participants	52 Participants n=77 Participants	58 Participants n=76 Participants	52 Participants n=74 Participants	400 Participants n=716 Participants	413 Participants n=717 Participants	1029 Participants n=1735 Participants
Race (NIH/OMB) More than one race	13 Participants n=75 Participants	15 Participants n=77 Participants	10 Participants n=76 Participants	13 Participants n=74 Participants	190 Participants n=716 Participants	202 Participants n=717 Participants	443 Participants n=1735 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=75 Participants	0 Participants n=77 Participants	0 Participants n=76 Participants	1 Participants n=74 Participants	0 Participants n=716 Participants	0 Participants n=717 Participants	1 Participants n=1735 Participants
Time from Symptom Onset to Randomization (Part 1) ≤5 Days	51 Participants n=75 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	52 Participants n=77 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	52 Participants n=76 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	50 Participants n=74 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	—	—	205 Participants n=302 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.
Time from Symptom Onset to Randomization (Part 1) >5 Days	24 Participants n=75 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	25 Participants n=77 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	24 Participants n=76 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	24 Participants n=74 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	—	—	97 Participants n=302 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.
At Increased Risk of Severe Illness from Coronavirus Disease (COVID-19) (Part 1) Yes	56 Participants n=75 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	58 Participants n=77 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	57 Participants n=76 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	56 Participants n=74 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	—	—	227 Participants n=302 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.
At Increased Risk of Severe Illness from Coronavirus Disease (COVID-19) (Part 1) No	19 Participants n=75 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	19 Participants n=77 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	19 Participants n=76 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	18 Participants n=74 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.	—	—	75 Participants n=302 Participants • Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only.
Time from Symptom Onset to Randomization (Part 2) ≤ 3 days	—	—	—	—	342 Participants n=716 Participants • Analysis population consisted of all randomized participants in Part 2. Per protocol, this stratification factor was applicable to Part 2 of the study only.	342 Participants n=717 Participants • Analysis population consisted of all randomized participants in Part 2. Per protocol, this stratification factor was applicable to Part 2 of the study only.	684 Participants n=1433 Participants • Analysis population consisted of all randomized participants in Part 2. Per protocol, this stratification factor was applicable to Part 2 of the study only.
Time from Symptom Onset to Randomization (Part 2) > 3 days	—	—	—	—	374 Participants n=716 Participants • Analysis population consisted of all randomized participants in Part 2. Per protocol, this stratification factor was applicable to Part 2 of the study only.	375 Participants n=717 Participants • Analysis population consisted of all randomized participants in Part 2. Per protocol, this stratification factor was applicable to Part 2 of the study only.	749 Participants n=1433 Participants • Analysis population consisted of all randomized participants in Part 2. Per protocol, this stratification factor was applicable to Part 2 of the study only.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=74 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=77 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=74 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=74 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=385 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=377 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis)	1.4 Percentage of Participants	3.9 Percentage of Participants	4.1 Percentage of Participants	5.4 Percentage of Participants	7.3 Percentage of Participants	14.1 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 318 days

Population: All randomized participants who received at least one dose of study treatment were analyzed.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=74 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=77 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=74 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=74 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=710 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=701 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Number of Participants With an Adverse Event (AE)	29 Participants	24 Participants	29 Participants	28 Participants	230 Participants	239 Participants

PRIMARY outcome

Timeframe: Up to 5 days

Population: All randomized participants who received at least one dose of study treatment were analyzed.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=74 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=77 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=74 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=74 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=710 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=701 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Number of Participants Who Discontinued Study Intervention Due to an AE	0 Participants	0 Participants	3 Participants	1 Participants	10 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=51 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=50 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=53 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=48 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=570 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=574 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough	7.0 Days Interval 5.0 to 10.0	6.5 Days Interval 4.0 to 10.0	8.0 Days Interval 6.0 to 11.0	6.0 Days Interval 4.0 to 7.0	10.0 Days Interval 9.0 to 11.0	10.0 Days Interval 8.0 to 11.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=22 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=31 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=28 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=30 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=318 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=296 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 5.0	4.5 Days Interval 3.0 to 8.0	5.0 Days Interval 3.0 to 7.0	4.0 Days Interval 4.0 to 5.0	5.0 Days Interval 5.0 to 6.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=48 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=41 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=40 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=54 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=439 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=429 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion	4.0 Days Interval 3.0 to 6.0	4.0 Days Interval 3.0 to 7.0	8.0 Days Interval 5.0 to 10.0	5.0 Days Interval 4.0 to 6.0	5.0 Days Interval 4.0 to 6.0	6.0 Days Interval 5.0 to 7.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=31 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=30 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=17 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=35 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=348 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=347 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea	4.0 Days Interval 2.0 to 6.0	8.0 Days Interval 5.0 to 10.0	9.0 Days Interval 5.0 to 21.0	5.0 Days Interval 3.0 to 6.0	5.0 Days Interval 4.0 to 6.0	5.0 Days Interval 5.0 to 6.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=20 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=25 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=30 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=28 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=258 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=260 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing	7.0 Days Interval 4.0 to 22.0	4.0 Days Interval 3.0 to 6.0	9.0 Days Interval 4.0 to 17.0	5.0 Days Interval 4.0 to 12.0	6.0 Days Interval 6.0 to 8.0	9.0 Days Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=49 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=42 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=36 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=47 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=460 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=454 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches	5.0 Days Interval 3.0 to 7.0	4.0 Days Interval 3.0 to 4.0	4.5 Days Interval 3.0 to 15.0	4.0 Days Interval 3.0 to 7.0	4.0 Days Interval 4.0 to 5.0	5.0 Days Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=56 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=51 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=56 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=52 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=538 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=528 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue	7.0 Days Interval 4.0 to 11.0	5.0 Days Interval 3.0 to 7.0	6.0 Days Interval 4.0 to 11.0	6.0 Days Interval 4.0 to 10.0	6.0 Days Interval 6.0 to 7.0	7.0 Days Interval 6.0 to 8.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=27 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=22 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=38 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=32 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=386 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=372 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish	4.0 Days Interval 3.0 to 6.0	2.0 Days Interval 2.0 to 3.0	4.0 Days Interval 3.0 to 5.0	3.5 Days Interval 2.0 to 4.0	3.0 Days Interval 3.0 to 4.0	4.0 Days Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=18 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=18 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=23 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=27 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=308 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=279 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills	2.0 Days Interval 2.0 to 5.0	2.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 3.0	4.0 Days Interval 2.0 to 5.0	3.0 Days Interval 2.0 to 3.0	NA Days NA = Median time to resolution/improvement and upper and lower limits not reached due to insufficient number of participants with sustained resolution or improvement after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=39 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=42 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=35 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=37 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=472 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=429 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache	4.0 Days Interval 3.0 to 6.0	4.0 Days Interval 3.0 to 7.0	4.0 Days Interval 3.0 to 10.0	6.0 Days Interval 3.0 to 10.0	5.0 Days Interval 4.0 to 5.0	5.0 Days Interval 5.0 to 6.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=16 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=17 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=10 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=16 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=176 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=171 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea	5.0 Days Interval 2.0 to 8.0	3.0 Days Interval 2.0 to 4.0	6.0 Days Interval 2.0 to 9.0	5.0 Days Interval 2.0 to 9.0	4.0 Days Interval 3.0 to 5.0	4.0 Days Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=2 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=2 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=2 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=5 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=49 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=38 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting	4.0 Days Interval 2.0 to 6.0	8.0 Days Interval 2.0 to 14.0	5.0 Days Interval 2.0 to 8.0	2.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0	NA Days NA = Median time to resolution/improvement and upper and lower limits not reached due to insufficient number of participants with sustained resolution or improvement after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=13 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=19 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=15 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=11 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=158 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=166 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea	6.0 Days Interval 2.0 to 13.0	4.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 6.0	2.0 Days Interval 2.0 to 3.0	3.0 Days Interval 3.0 to 4.0	3.0 Days Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=33 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=15 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=18 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=30 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=242 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=262 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste	6.0 Days Interval 4.0 to 9.0	6.0 Days Interval 4.0 to 11.0	10.0 Days Interval 4.0 to 19.0	9.0 Days Interval 5.0 to 16.0	9.0 Days Interval 8.0 to 10.0	10.0 Days Interval 8.0 to 12.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=38 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=29 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=24 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=36 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=318 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=323 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell	7.0 Days Interval 6.0 to 9.0	10.0 Days Interval 6.0 to 18.0	12.0 Days Interval 6.0 to 19.0	12.0 Days Interval 7.0 to 16.0	10.0 Days Interval 9.0 to 11.0	11.0 Days Interval 9.0 to 14.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=68 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=70 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=66 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=67 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=688 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=672 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=71 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=72 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=70 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=67 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=695 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=681 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=71 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=71 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=69 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=67 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=682 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=664 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants experiencing progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants experiencing progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants experiencing progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants experiencing progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants experiencing progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants experiencing progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=71 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=72 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=65 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=67 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=694 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=690 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=69 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=70 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=68 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=701 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=681 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=66 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=71 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=68 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=62 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=655 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=640 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=64 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=69 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=62 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=60 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=659 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=637 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=68 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=71 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=65 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=66 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=676 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=673 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=68 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=72 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=70 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=66 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=679 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=676 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=69 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=72 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=69 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=67 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=640 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=640 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=72 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=70 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=69 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=688 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=686 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=72 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=71 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=69 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=702 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=692 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=72 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=73 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=68 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=67 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=695 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=691 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=38 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=56 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=48 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=37 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=461 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=433 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1: Molnupiravir 200 mg n=33 Participants 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 400 mg n=42 Participants 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Molnupiravir 800 mg n=42 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 1: Placebo n=31 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Molnupiravir 800 mg n=385 Participants 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Part 2: Placebo n=372 Participants Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.	NA Days NA = Median time to progression and upper and lower limits not reached due to an insufficient number of participants with progression after randomization.

SECONDARY outcome

Timeframe: 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.