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Trial record 5 of 17 for:    molnupiravir

Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04575584
Recruitment Status : Terminated (Business reasons)
First Posted : October 5, 2020
Results First Posted : August 16, 2022
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Coronavirus Disease (COVID-19)
Interventions Drug: Molnupiravir
Drug: Placebo
Enrollment 304
Recruitment Details Participants were enrolled at 86 study centers in 15 countries.
Pre-assignment Details  
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total) Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Period Title: Overall Study
Started 75 75 76 78 0 [1] 0 [1]
Treated 73 73 72 75 0 0
Completed 61 60 63 70 0 0
Not Completed 14 15 13 8 0 0
Reason Not Completed
Death             6             4             6             2             0             0
Lost to Follow-up             1             1             1             1             0             0
Physician Decision             0             1             1             1             0             0
Withdrawal by Subject             7             9             5             3             0             0
Not recorded             0             0             0             1             0             0
[1]
Study terminated prior to initiating Part 2
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo Total
Hide Arm/Group Description 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total) Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) Total of all reporting groups
Overall Number of Baseline Participants 75 75 76 78 0 0 304
Hide Baseline Analysis Population Description
No participants were enrolled in Part 2 arms due to early study termination.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 75 participants 76 participants 78 participants 0 participants 0 participants 304 participants
56.9  (14.2) 57.0  (14.0) 56.8  (13.7) 57.1  (14.2) 57.0  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 76 participants 78 participants 0 participants 0 participants 304 participants
Female
32
  42.7%
34
  45.3%
32
  42.1%
34
  43.6%
0 0
132
  43.4%
Male
43
  57.3%
41
  54.7%
44
  57.9%
44
  56.4%
0 0
172
  56.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 76 participants 78 participants 0 participants 0 participants 304 participants
Hispanic or Latino
27
  36.0%
32
  42.7%
28
  36.8%
27
  34.6%
0 0
114
  37.5%
Not Hispanic or Latino
47
  62.7%
42
  56.0%
46
  60.5%
49
  62.8%
0 0
184
  60.5%
Unknown or Not Reported
1
   1.3%
1
   1.3%
2
   2.6%
2
   2.6%
0 0
6
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 76 participants 78 participants 0 participants 0 participants 304 participants
American Indian or Alaska Native
0
   0.0%
3
   4.0%
1
   1.3%
2
   2.6%
0 0
6
   2.0%
Asian
10
  13.3%
8
  10.7%
4
   5.3%
1
   1.3%
0 0
23
   7.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   1.3%
0
   0.0%
0 0
1
   0.3%
Black or African American
1
   1.3%
4
   5.3%
6
   7.9%
7
   9.0%
0 0
18
   5.9%
White
58
  77.3%
52
  69.3%
54
  71.1%
63
  80.8%
0 0
227
  74.7%
More than one race
6
   8.0%
7
   9.3%
9
  11.8%
5
   6.4%
0 0
27
   8.9%
Unknown or Not Reported
0
   0.0%
1
   1.3%
1
   1.3%
0
   0.0%
0 0
2
   0.7%
1.Primary Outcome
Title Time-to-sustained Recovery
Hide Description The median time to sustained recovery is reported. Sustained recovery is defined as 1) the participant is alive and not hospitalized; or 2) the participant is alive and medically ready for discharge as determined by the investigator.
Time Frame Up to 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Median (95% Confidence Interval)
Unit of Measure: days
9.0
(7.0 to 10.0)
9.0
(8.0 to 10.0)
9.0
(8.0 to 11.0)
9.0
(8.0 to 11.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5620
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.68 to 1.45
Estimation Comments Based on Cox regression model with Efron's method of tie handling
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3145
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.78 to 1.65
Estimation Comments Based on Cox regression model with Efron's method of tie handling
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4894
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.69 to 1.47
Estimation Comments Based on Cox regression model with Efron's method of tie handling
2.Primary Outcome
Title Number of Participants With an Adverse Event (AE)
Hide Description The number of participants with at least 1 AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame Up to 19 days (during treatment and 14-day follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
40
  54.8%
36
  49.3%
45
  62.5%
46
  61.3%
3.Primary Outcome
Title Number of Participants Who Discontinued Study Intervention Due to an AE
Hide Description The number of participants discontinuing from study treatment due to an AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame Up to 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   1.4%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Participants With All-cause Mortality
Hide Description The number of participants with all-cause mortality through Day 29 is presented. All-cause mortality is defined as death due to any cause. Any participants with an unknown survival status at Day 29 were imputed as deceased.
Time Frame Up to 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
4
   5.5%
5
   6.8%
4
   5.6%
1
   1.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1642
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-2.3 to 12.1
Estimation Comments Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0900
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.5
Confidence Interval (2-Sided) 95%
-1.1 to 13.9
Estimation Comments Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1594
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
-2.3 to 12.3
Estimation Comments Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.
5.Secondary Outcome
Title Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3
Hide Description Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
25
  34.7%
20
  27.8%
21
  29.2%
16
  21.9%
2 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
2
   2.8%
7
   9.7%
0
   0.0%
7
   9.6%
3 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
21
  29.2%
20
  27.8%
23
  31.9%
25
  34.2%
4 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
16
  22.2%
16
  22.2%
19
  26.4%
14
  19.2%
5 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
7
   9.7%
9
  12.5%
6
   8.3%
10
  13.7%
6 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
1
   1.4%
0
   0.0%
3
   4.2%
1
   1.4%
7 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
1
   1.4%
1
   1.4%
0
   0.0%
2
   2.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3623
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.73 to 2.35
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. Confidence intervals (CIs) are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5714
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.66 to 2.12
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9313
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.54 to 1.75
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
6.Secondary Outcome
Title Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5])
Hide Description Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.
Time Frame EOT (Day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
30
  42.3%
22
  32.4%
26
  37.1%
27
  38.6%
2 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
6
   8.5%
5
   7.4%
4
   5.7%
4
   5.7%
3 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
17
  23.9%
18
  26.5%
15
  21.4%
16
  22.9%
4 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
10
  14.1%
14
  20.6%
14
  20.0%
14
  20.0%
5 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
7
   9.9%
8
  11.8%
8
  11.4%
8
  11.4%
6 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
1
   1.4%
1
   1.5%
3
   4.3%
1
   1.4%
7 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
2
   2.7%
5
   6.8%
2
   2.8%
5
   6.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4398
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.70 to 2.30
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6277
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.47 to 1.57
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7069
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.49 to 1.62
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
7.Secondary Outcome
Title Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10
Hide Description Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
44
  64.7%
39
  60.9%
33
  49.3%
38
  54.3%
2 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
4
   5.9%
4
   6.3%
4
   6.0%
5
   7.1%
3 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
8
  11.8%
8
  12.5%
14
  20.9%
10
  14.3%
4 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
5
   7.4%
7
  10.9%
8
  11.9%
10
  14.3%
5 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
4
   5.9%
3
   4.7%
5
   7.5%
4
   5.7%
6 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
3
   4.4%
0
   0.0%
3
   4.5%
3
   4.3%
7 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
0
   0.0%
3
   4.7%
0
   0.0%
0
   0.0%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
5
   6.8%
9
  12.3%
5
   6.9%
5
   6.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2422
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
0.77 to 2.85
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4789
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.66 to 2.44
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6052
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.45 to 1.59
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
8.Secondary Outcome
Title Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15
Hide Description Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
45
  67.2%
44
  71.0%
41
  60.3%
42
  59.2%
2 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
7
  10.4%
2
   3.2%
2
   2.9%
5
   7.0%
3 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
6
   9.0%
6
   9.7%
14
  20.6%
10
  14.1%
4 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
3
   4.5%
5
   8.1%
3
   4.4%
6
   8.5%
5 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
2
   3.0%
1
   1.6%
0
   0.0%
4
   5.6%
6 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
4
   6.0%
1
   1.6%
7
  10.3%
3
   4.2%
7 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
0
   0.0%
3
   4.8%
1
   1.5%
1
   1.4%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
6
   8.2%
11
  15.1%
4
   5.6%
4
   5.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2644
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
0.75 to 2.88
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2184
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
0.77 to 3.14
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9771
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.53 to 1.94
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
9.Secondary Outcome
Title Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29
Hide Description Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
46
  73.0%
47
  79.7%
47
  68.1%
49
  71.0%
2 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
2
   3.2%
2
   3.4%
2
   2.9%
5
   7.2%
3 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
4
   6.3%
5
   8.5%
9
  13.0%
7
  10.1%
4 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
5
   7.9%
1
   1.7%
3
   4.3%
5
   7.2%
5 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
2
   3.2%
0
   0.0%
5
   7.2%
2
   2.9%
7 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
4
   6.3%
4
   6.8%
3
   4.3%
1
   1.4%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
10
  13.7%
14
  19.2%
3
   4.2%
6
   8.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9945
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.46 to 2.06
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3227
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
0.67 to 3.37
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5200
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.39 to 1.61
Estimation Comments Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
10.Secondary Outcome
Title Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3
Hide Description Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
25
  34.7%
20
  27.8%
21
  29.2%
16
  21.9%
2 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
2
   2.8%
7
   9.7%
0
   0.0%
7
   9.6%
3 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
20
  27.8%
20
  27.8%
23
  31.9%
25
  34.2%
4 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
16
  22.2%
16
  22.2%
19
  26.4%
14
  19.2%
5 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
7
   9.7%
9
  12.5%
6
   8.3%
10
  13.7%
6 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
2
   2.8%
0
   0.0%
3
   4.2%
1
   1.4%
7 Number Analyzed 72 participants 72 participants 72 participants 73 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
1
   1.4%
1
   1.4%
0
   0.0%
2
   2.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4472
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.70 to 2.25
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5714
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.66 to 2.12
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9313
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.54 to 1.75
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
11.Secondary Outcome
Title Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5)
Hide Description Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.
Time Frame EOT (Day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
30
  42.3%
22
  32.4%
26
  37.1%
27
  38.6%
2 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
6
   8.5%
5
   7.4%
4
   5.7%
4
   5.7%
3 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
16
  22.5%
18
  26.5%
15
  21.4%
16
  22.9%
4 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
10
  14.1%
14
  20.6%
14
  20.0%
14
  20.0%
5 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
7
   9.9%
8
  11.8%
8
  11.4%
8
  11.4%
6 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
2
   2.8%
1
   1.5%
3
   4.3%
1
   1.4%
7 Number Analyzed 71 participants 68 participants 70 participants 70 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
2
   2.7%
5
   6.8%
2
   2.8%
5
   6.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5222
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.67 to 2.21
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6277
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.47 to 1.57
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7069
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.49 to 1.62
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
12.Secondary Outcome
Title Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10
Hide Description Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
44
  64.7%
39
  60.9%
33
  49.3%
38
  54.3%
2 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
4
   5.9%
4
   6.3%
4
   6.0%
5
   7.1%
3 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
8
  11.8%
8
  12.5%
14
  20.9%
10
  14.3%
4 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
4
   5.9%
7
  10.9%
8
  11.9%
10
  14.3%
5 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
4
   5.9%
3
   4.7%
4
   6.0%
4
   5.7%
6 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
4
   5.9%
0
   0.0%
4
   6.0%
3
   4.3%
7 Number Analyzed 68 participants 64 participants 67 participants 70 participants 0 participants 0 participants
0
   0.0%
3
   4.7%
0
   0.0%
0
   0.0%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
5
   6.8%
9
  12.3%
5
   6.9%
5
   6.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2627
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.46
Confidence Interval (2-Sided) 95%
0.75 to 2.80
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4789
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.66 to 2.44
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5938
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.45 to 1.58
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
13.Secondary Outcome
Title Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15
Hide Description Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
45
  67.2%
44
  71.0%
41
  60.3%
42
  59.2%
2 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
7
  10.4%
2
   3.2%
2
   2.9%
5
   7.0%
3 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
6
   9.0%
6
   9.7%
14
  20.6%
10
  14.1%
4 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
3
   4.5%
5
   8.1%
3
   4.4%
6
   8.5%
5 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
2
   3.0%
1
   1.6%
0
   0.0%
4
   5.6%
6 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
4
   6.0%
1
   1.6%
7
  10.3%
3
   4.2%
7 Number Analyzed 67 participants 62 participants 68 participants 71 participants 0 participants 0 participants
0
   0.0%
3
   4.8%
1
   1.5%
1
   1.4%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
6
   8.2%
11
  15.1%
4
   5.6%
4
   5.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2644
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
0.75 to 2.88
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2184
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
0.77 to 3.14
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9771
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.53 to 1.94
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
14.Secondary Outcome
Title Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29
Hide Description Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity in hospitalized participants, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 ("can independently undertake personal usual activities with minimal or no symptoms") to 7 ("death") with a higher score indicating more severe respiratory sequalae. The number of participants at each score category is presented.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data available at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
46
  73.0%
47
  79.7%
47
  68.1%
49
  71.0%
2 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
2
   3.2%
2
   3.4%
2
   2.9%
5
   7.2%
3 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
4
   6.3%
5
   8.5%
9
  13.0%
7
  10.1%
4 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
5
   7.9%
1
   1.7%
3
   4.3%
5
   7.2%
5 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
2
   3.2%
0
   0.0%
5
   7.2%
2
   2.9%
7 Number Analyzed 63 participants 59 participants 69 participants 69 participants 0 participants 0 participants
4
   6.3%
4
   6.8%
3
   4.3%
1
   1.4%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
10
  13.7%
14
  19.2%
3
   4.2%
6
   8.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9445
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.46 to 2.06
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3227
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
0.67 to 3.37
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5200
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.39 to 1.61
Estimation Comments Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
15.Secondary Outcome
Title Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score
Hide Description The National Early Warning Score (Royal College of Physicians, 2012) assesses a participant's degree of illness as assessed by clinical risk prediction categories based on a set of vital sign measurements. There are 7 physiological parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0 to 3 was allocated to each parameter except supplemental oxygen use (score of 0 [no] or 1 [yes]) and level of consciousness (score of 0 or 3 with 0 = normal health condition and 3 = worst health condition). All scores were summed to get an aggregate score. Aggregate NEWS score ranged from 0 to 19, with higher scores meaning more severity/higher risk: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19). The number of participants at each aggregate risk category is presented.
Time Frame EOT (Day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Low Number Analyzed 70 participants 64 participants 69 participants 69 participants 0 participants 0 participants
57
  81.4%
45
  70.3%
52
  75.4%
55
  79.7%
Medium Number Analyzed 70 participants 64 participants 69 participants 69 participants 0 participants 0 participants
8
  11.4%
8
  12.5%
9
  13.0%
11
  15.9%
High Number Analyzed 70 participants 64 participants 69 participants 69 participants 0 participants 0 participants
5
   7.1%
11
  17.2%
8
  11.6%
3
   4.3%
Missing Number Analyzed 70 participants 64 participants 69 participants 69 participants 0 participants 0 participants
3
   4.3%
9
  14.1%
3
   4.3%
6
   8.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8732
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.46 to 2.47
Estimation Comments Proportional odds model with National Early Warning Score (NEWS) categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1277
Comments [Not Specified]
Method Wald Chi-square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.25 to 1.19
Estimation Comments Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4326
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.33 to 1.61
Estimation Comments Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
16.Secondary Outcome
Title Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3
Hide Description The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
1
   1.4%
1
   1.4%
0
   0.0%
2
   2.7%
3
1
   1.4%
0
   0.0%
0
   0.0%
1
   1.3%
4
27
  37.0%
27
  37.0%
21
  29.2%
24
  32.0%
5
36
  49.3%
36
  49.3%
42
  58.3%
37
  49.3%
6
7
   9.6%
9
  12.3%
6
   8.3%
10
  13.3%
7
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8
0
   0.0%
0
   0.0%
2
   2.8%
0
   0.0%
9
1
   1.4%
0
   0.0%
1
   1.4%
1
   1.3%
10
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6830
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
0.50 to 2.88
Estimation Comments Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.42 to 2.39
Estimation Comments Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8244
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.37 to 2.20
Estimation Comments Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
17.Secondary Outcome
Title Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5)
Hide Description The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.
Time Frame EOT (Day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0 Number Analyzed 71 participants 68 participants 70 participants 72 participants 0 participants 0 participants
2
   2.8%
0
   0.0%
1
   1.4%
0
   0.0%
1 Number Analyzed 71 participants 68 participants 70 participants 72 participants 0 participants 0 participants
2
   2.8%
1
   1.5%
1
   1.4%
2
   2.8%
2 Number Analyzed 71 participants 68 participants 70 participants 72 participants 0 participants 0 participants
3
   4.2%
5
   7.4%
0
   0.0%
9
  12.5%
3 Number Analyzed 71 participants 68 participants 70 participants 72 participants 0 participants 0 participants
0
   0.0%
2
   2.9%
2
   2.9%
1
   1.4%
4 Number Analyzed 71 participants 68 participants 70 participants 72 participants 0 participants 0 participants
29
  40.8%
20
  29.4%
27
  38.6%
25
  34.7%
5 Number Analyzed 71 participants 68 participants 70 participants 72 participants 0 participants 0 participants
27
  38.0%
31
  45.6%
28
  40.0%
26
  36.1%
6 Number Analyzed 71 participants 68 participants 70 participants 72 participants 0 participants 0 participants
7
   9.9%
8
  11.8%
8
  11.4%
8
  11.1%
7 Number Analyzed 71 participants 68 participants 70 participants 72 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8 Number Analyzed 71 participants 68 participants 70 participants 72 participants 0 participants 0 participants
1
   1.4%
1
   1.5%
1
   1.4%
0
   0.0%
9 Number Analyzed 71 participants 68 participants 70 participants 72 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
2
   2.9%
1
   1.4%
10 Number Analyzed 71 participants 68 participants 70 participants 72 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
2
   2.7%
5
   6.8%
2
   2.8%
3
   4.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5022
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.36 to 1.64
Estimation Comments Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5204
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.37 to 1.64
Estimation Comments Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0991
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.24 to 1.13
Estimation Comments Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
18.Secondary Outcome
Title Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10
Hide Description The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0 Number Analyzed 68 participants 64 participants 67 participants 69 participants 0 participants 0 participants
3
   4.4%
4
   6.3%
2
   3.0%
3
   4.3%
1 Number Analyzed 68 participants 64 participants 67 participants 69 participants 0 participants 0 participants
10
  14.7%
7
  10.9%
7
  10.4%
7
  10.1%
2 Number Analyzed 68 participants 64 participants 67 participants 69 participants 0 participants 0 participants
26
  38.2%
19
  29.7%
22
  32.8%
21
  30.4%
3 Number Analyzed 68 participants 64 participants 67 participants 69 participants 0 participants 0 participants
3
   4.4%
4
   6.3%
7
  10.4%
8
  11.6%
4 Number Analyzed 68 participants 64 participants 67 participants 69 participants 0 participants 0 participants
8
  11.8%
16
  25.0%
7
  10.4%
13
  18.8%
5 Number Analyzed 68 participants 64 participants 67 participants 69 participants 0 participants 0 participants
11
  16.2%
9
  14.1%
14
  20.9%
11
  15.9%
6 Number Analyzed 68 participants 64 participants 67 participants 69 participants 0 participants 0 participants
4
   5.9%
2
   3.1%
5
   7.5%
3
   4.3%
7 Number Analyzed 68 participants 64 participants 67 participants 69 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
1
   1.5%
0
   0.0%
8 Number Analyzed 68 participants 64 participants 67 participants 69 participants 0 participants 0 participants
2
   2.9%
0
   0.0%
0
   0.0%
3
   4.3%
9 Number Analyzed 68 participants 64 participants 67 participants 69 participants 0 participants 0 participants
1
   1.5%
0
   0.0%
2
   3.0%
0
   0.0%
10 Number Analyzed 68 participants 64 participants 67 participants 69 participants 0 participants 0 participants
0
   0.0%
3
   4.7%
0
   0.0%
0
   0.0%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
5
   6.8%
9
  12.3%
5
   6.9%
6
   8.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6346
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.60 to 2.29
Estimation Comments Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7596
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.46 to 1.75
Estimation Comments Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8879
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.49 to 1.84
Estimation Comments Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
19.Secondary Outcome
Title Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15
Hide Description The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
Arm/Group Title Part 1: Molnupiravir 200 mg Part 1: Molnupiravir 400 mg Part 1: Molnupiravir 800 mg Part 1: Placebo Part 2: Molnupiravir Part 2: Placebo
Hide Arm/Group Description:
200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Overall Number of Participants Analyzed 73 73 72 75 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0 Number Analyzed 67 participants 61 participants 68 participants 70 participants 0 participants 0 participants
10
  14.9%
8
  13.1%
10
  14.7%
8
  11.4%
1 Number Analyzed 67 participants 61 participants 68 participants 70 participants 0 participants 0 participants
12
  17.9%
12
  19.7%
9
  13.2%
11
  15.7%
2 Number Analyzed 67 participants 61 participants 68 participants 70 participants 0 participants 0 participants
25
  37.3%
25
  41.0%
27
  39.7%
27
  38.6%
3 Number Analyzed 67 participants 61 participants 68 participants 70 participants 0 participants 0 participants
7
  10.4%
5
   8.2%
4
   5.9%
8
  11.4%
4 Number Analyzed 67 participants 61 participants 68 participants 70 participants 0 participants 0 participants
4
   6.0%
3
   4.9%
3
   4.4%
5
   7.1%
5 Number Analyzed 67 participants 61 participants 68 participants 70 participants 0 participants 0 participants
4
   6.0%
4
   6.6%
7
  10.3%
4
   5.7%
6 Number Analyzed 67 participants 61 participants 68 participants 70 participants 0 participants 0 participants
2
   3.0%
0
   0.0%
0
   0.0%
3
   4.3%
7 Number Analyzed 67 participants 61 participants 68 participants 70 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
2
   2.9%
1
   1.4%
8 Number Analyzed 67 participants 61 participants 68 participants 70 participants 0 participants 0 participants
3
   4.5%
0
   0.0%
1
   1.5%
0
   0.0%
9 Number Analyzed 67 participants 61 participants 68 participants 70 participants 0 participants 0 participants
0
   0.0%
1
   1.6%
4
   5.9%
2
   2.9%
10 Number Analyzed 67 participants 61 participants 68 participants 70 participants 0 participants 0 participants
0
   0.0%
3
   4.9%
1
   1.5%
1
   1.4%
Missing Number Analyzed 73 participants 73 participants 72 participants 75 participants 0 participants 0 participants
6
   8.2%
12
  16.4%
4
   5.6%
5
   6.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6002
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
0.55 to 2.82
Estimation Comments Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 400 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4733
Comments [Not Specified]
Method Wald Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
0.58 to 3.21
Estimation Comments Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.
Hide Statistical Analysis 3 <
Statistical Analysis Overview Comparison Group Selection Part 1: Molnupiravir 800 mg, Part 1: Placebo
Comments [Not Specified]