Coronavirus Disease (COVID-19)
Conditions
Brief summary
This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the rate of sustained recovery through Day 29.
Detailed description
This study was intended to include two parts: Part 1 was a dose-ranging phase 2 study, and Part 2 was a phase 3 study to evaluate the dose selected in Part 1. However, this study was terminated due to business reasons prior to conducting Part 2. Participants in Part 1 were followed until Month 7.
Interventions
DRUGMolnupiravir
Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
DRUGPlacebo
Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has documentation of polymerase chain reaction (PCR)-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤ 10 days prior to the day of randomization. PCR is the preferred method; however other diagnostic methods are allowed if authorized by use in the country * Had initial onset of signs/symptoms attributable to COVID-19 for ≤10 days prior to the day of randomization and ≥1 sign/symptom attributable to COVID-19 present at randomization * Requires medical care in the hospital for ongoing clinical manifestations of COVID-19 (not just for public health or quarantine purposes) * Has mild, moderate, or severe COVID-19 * Is willing and able to take oral medication * Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm; and either abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception * Females are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention
Exclusion criteria
* Has critical COVID-19 with any of the following: respiratory failure (including endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (flow rates \>20L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ECMO)) * Is on dialysis or has reduced estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2 by the Modification of Diet in Renal Disease (MDRD) equation * Has any of the following conditions: human immunodeficiency virus (HIV) with a recent viral load \>50 copies/mL or cluster of differentiation 4 (CD4) \<200 cell/mm\^3; chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count \<500/mm\^3; autologous or allogeneic hematopoietic stem cell transplant recipient * Has history of Hepatitis B or Hepatitis C infection with any of the following: 1) cirrhosis 2) end-stage liver disease 3) hepatocellular carcinoma 4) aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 times the upper limit of normal at screening * Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis * Is taking or is anticipated to require any prohibited therapies * Is unwilling to abstain from participating in another interventional clinical trial through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics * Is anticipated to require transfer to a non-study hospital within 72 hours * Has a baseline heart rate of \< 50 beats per minute at rest * Has a platelet count \<100,000/μL or received a platelet transfusion in the 5 days prior to randomization * Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization or participants who are expected to require mechanical ventilation within 48 hours after randomization or participants with a recent history of mechanical ventilation or participants with conditions that could limit gastrointestinal absorption of capsule contents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-sustained Recovery | Up to 29 days | 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. |
| Number of Participants With an Adverse Event (AE) | Up to 19 days (during treatment and 14-day follow-up) | The number of participants with at least 1 AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Number of Participants Who Discontinued Study Intervention Due to an AE | Up to 5 days | The number of participants 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | Day 10 | 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. |
| Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | Day 15 | 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. |
| Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | Day 29 | 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. |
| Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | Day 3 | 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. |
| Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | EOT (Day 5) | 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. |
| Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | Day 10 | 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. |
| Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | Day 15 | 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. |
| Number of Participants With All-cause Mortality | Up to 29 days | 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. |
| Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | EOT (Day 5) | 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 2 \[yes\]) 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. |
| Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | Day 3 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 (uninfected) to 10 (dead) with higher score indicating clinical progression. The number of participants at each score category is presented. |
| Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | EOT (Day 5) | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 (uninfected) to 10 (dead) with higher score indicating clinical progression. The number of participants at each score category is presented. |
| Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | Day 10 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 (uninfected) to 10 (dead) with higher score indicating clinical progression. The number of participants at each score category is presented. |
| Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | Day 15 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 (uninfected) to 10 (dead) with higher score indicating clinical progression. The number of participants at each score category is presented. |
| Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | Day 29 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 (uninfected) to 10 (dead) with higher score indicating clinical progression. The number of participants at each score category is presented. |
| Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | Day 29 | 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. |
| Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | Day 3 | 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. |
| Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | EOT (Day 5) | 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. |
Countries
Brazil, Canada, Chile, Colombia, France, Israel, Italy, Mexico, Philippines, Poland, Russia, South Africa, South Korea, Spain, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at 86 study centers in 15 countries.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Molnupiravir 200 mg 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 75 |
| Part 1: Molnupiravir 400 mg 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 75 |
| Part 1: Molnupiravir 800 mg 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 76 |
| Part 1: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 78 |
| Part 2: Molnupiravir Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total) | 0 |
| Part 2: Placebo Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 0 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 6 | 4 | 6 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Not recorded | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 9 | 5 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1: Molnupiravir 200 mg | Part 1: Molnupiravir 800 mg | Part 1: Molnupiravir 400 mg | Part 1: Placebo | Total | Part 2: Molnupiravir | Part 2: Placebo |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 14.2 | 56.8 years STANDARD_DEVIATION 13.7 | 57.0 years STANDARD_DEVIATION 14 | 57.1 years STANDARD_DEVIATION 14.2 | 57.0 years STANDARD_DEVIATION 14 | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 28 Participants | 32 Participants | 27 Participants | 114 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 46 Participants | 42 Participants | 49 Participants | 184 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 6 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 6 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 4 Participants | 8 Participants | 1 Participants | 23 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 4 Participants | 7 Participants | 18 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 9 Participants | 7 Participants | 5 Participants | 27 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 58 Participants | 54 Participants | 52 Participants | 63 Participants | 227 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 32 Participants | 32 Participants | 34 Participants | 34 Participants | 132 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 43 Participants | 44 Participants | 41 Participants | 44 Participants | 172 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 75 | 4 / 75 | 7 / 76 | 2 / 78 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 11 / 73 | 11 / 73 | 7 / 72 | 13 / 75 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 11 / 73 | 9 / 73 | 13 / 72 | 12 / 75 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Who Discontinued Study Intervention Due to an AE
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
Population: All randomized participants in Part 1 who received ≥1 dose of study drug are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Number of Participants Who Discontinued Study Intervention Due to an AE | 0 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants Who Discontinued Study Intervention Due to an AE | 1 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants Who Discontinued Study Intervention Due to an AE | 0 Participants |
| Part 1: Placebo | Number of Participants Who Discontinued Study Intervention Due to an AE | 0 Participants |
Primary
Number of Participants With an Adverse Event (AE)
The number of participants with at least 1 AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 19 days (during treatment and 14-day follow-up)
Population: All randomized participants in Part 1 who received ≥1 dose of study drug are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Number of Participants With an Adverse Event (AE) | 40 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With an Adverse Event (AE) | 36 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With an Adverse Event (AE) | 45 Participants |
| Part 1: Placebo | Number of Participants With an Adverse Event (AE) | 46 Participants |
Primary
Time-to-sustained Recovery
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
Population: All randomized participants in Part 1 who received ≥1 dose of study drug are included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Time-to-sustained Recovery | 9.0 days |
| Part 1: Molnupiravir 400 mg | Time-to-sustained Recovery | 9.0 days |
| Part 1: Molnupiravir 800 mg | Time-to-sustained Recovery | 9.0 days |
| Part 1: Placebo | Time-to-sustained Recovery | 9.0 days |
p-value: 0.56295% CI: [0.68, 1.45]Log Rank
p-value: 0.314595% CI: [0.78, 1.65]Log Rank
p-value: 0.489495% CI: [0.69, 1.47]Log Rank
Secondary
Number of Participants With All-cause Mortality
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
Population: All randomized participants in Part 1 who received ≥1 dose of study drug are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Molnupiravir 200 mg | Number of Participants With All-cause Mortality | 4 Participants |
| Part 1: Molnupiravir 400 mg | Number of Participants With All-cause Mortality | 5 Participants |
| Part 1: Molnupiravir 800 mg | Number of Participants With All-cause Mortality | 4 Participants |
| Part 1: Placebo | Number of Participants With All-cause Mortality | 1 Participants |
p-value: 0.164295% CI: [-2.3, 12.1]Miettinen and Nurminen method
p-value: 0.0995% CI: [-1.1, 13.9]Miettinen and Nurminen method
p-value: 0.159495% CI: [-2.3, 12.3]Miettinen and Nurminen method
Secondary
Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score
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 2 \[yes\]) 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)
Population: All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Low | 57 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Medium | 8 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | High | 5 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Missing | 3 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Medium | 8 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | High | 11 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Missing | 9 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Low | 45 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | High | 8 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Medium | 9 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Missing | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Low | 52 Participants |
| Part 1: Placebo | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Missing | 6 Participants |
| Part 1: Placebo | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Medium | 11 Participants |
| Part 1: Placebo | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | Low | 55 Participants |
| Part 1: Placebo | Odds of a More Favorable Response in the Clinical Risk of Mortality Category From the National Early Warning Score | High | 3 Participants |
p-value: 0.873295% CI: [0.46, 2.47]Wald Chi-Square
p-value: 0.127795% CI: [0.25, 1.19]Wald Chi-square
p-value: 0.432695% CI: [0.33, 1.61]Wald Chi-Square
Secondary
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 1 | 44 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 2 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 3 | 8 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 4 | 5 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 5 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 6 | 3 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | Missing | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 5 | 3 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 2 | 4 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | Missing | 9 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 7 | 3 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 4 | 7 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 3 | 8 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 1 | 39 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 3 | 14 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 4 | 8 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 5 | 5 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 6 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | Missing | 5 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 1 | 33 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 2 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 3 | 10 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 4 | 10 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 2 | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 1 | 38 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 5 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | Missing | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 7 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 10 | 6 | 3 Participants |
p-value: 0.242295% CI: [0.77, 2.85]Wald Chi-Square
p-value: 0.478995% CI: [0.66, 2.44]Wald Chi-Square
p-value: 0.605295% CI: [0.45, 1.59]Wald Chi-Square
Secondary
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 1 | 44 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 2 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 3 | 8 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 4 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 5 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 6 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | Missing | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 5 | 3 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 2 | 4 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | Missing | 9 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 7 | 3 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 4 | 7 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 3 | 8 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 1 | 39 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 3 | 14 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 4 | 8 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 5 | 4 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 6 | 4 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | Missing | 5 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 1 | 33 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 2 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 3 | 10 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 4 | 10 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 2 | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 1 | 38 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 5 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | Missing | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 7 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 10 | 6 | 3 Participants |
p-value: 0.262795% CI: [0.75, 2.8]Wald Chi-Square
p-value: 0.478995% CI: [0.66, 2.44]Wald Chi-Square
p-value: 0.593895% CI: [0.45, 1.58]Wald Chi-Square
Secondary
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 1 | 45 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 2 | 7 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 3 | 6 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 4 | 3 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 5 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 6 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | Missing | 6 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 6 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 5 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 2 | 2 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | Missing | 11 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 7 | 3 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 4 | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 3 | 6 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 1 | 44 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 7 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 3 | 14 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 4 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 5 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 6 | 7 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | Missing | 4 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 1 | 41 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 2 | 2 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 3 | 10 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 4 | 6 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 2 | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 1 | 42 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 5 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | Missing | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 7 | 1 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 15 | 6 | 3 Participants |
p-value: 0.264495% CI: [0.75, 2.88]Wald Chi-Square
p-value: 0.218495% CI: [0.77, 3.14]Wald Chi-Square
p-value: 0.977195% CI: [0.53, 1.94]Wald Chi-Square
Secondary
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 1 | 45 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 2 | 7 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 3 | 6 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 4 | 3 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 5 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 6 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | Missing | 6 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 6 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 5 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 2 | 2 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | Missing | 11 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 7 | 3 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 4 | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 3 | 6 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 1 | 44 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 7 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 3 | 14 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 4 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 5 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 6 | 7 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | Missing | 4 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 1 | 41 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 2 | 2 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 3 | 10 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 4 | 6 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 2 | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 1 | 42 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 5 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | Missing | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 7 | 1 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 15 | 6 | 3 Participants |
p-value: 0.264495% CI: [0.75, 2.88]Wald Chi-Square
p-value: 0.218495% CI: [0.77, 3.14]Wald Chi-Square
p-value: 0.977195% CI: [0.53, 1.94]Wald Chi-Square
Secondary
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 1 | 46 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 2 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 3 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 4 | 5 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 5 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 6 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 7 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | Missing | 10 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 5 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 2 | 2 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | Missing | 14 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 7 | 4 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 4 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 3 | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 1 | 47 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 7 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 3 | 9 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 4 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 5 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 6 | 5 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | Missing | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 1 | 47 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 2 | 2 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 3 | 7 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 4 | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 2 | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 1 | 49 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 5 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | Missing | 6 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 7 | 1 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 29 | 6 | 2 Participants |
p-value: 0.994595% CI: [0.46, 2.06]Wald Chi-Square
p-value: 0.322795% CI: [0.67, 3.37]Wald Chi-Square
p-value: 0.5295% CI: [0.39, 1.61]Wald Chi-Square
Secondary
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 1 | 46 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 2 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 3 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 4 | 5 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 5 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 6 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 7 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | Missing | 10 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 5 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 2 | 2 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | Missing | 14 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 7 | 4 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 4 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 3 | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 1 | 47 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 7 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 3 | 9 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 4 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 5 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 6 | 5 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | Missing | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 1 | 47 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 2 | 2 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 3 | 7 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 4 | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 2 | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 1 | 49 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 5 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | Missing | 6 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 7 | 1 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 29 | 6 | 2 Participants |
p-value: 0.944595% CI: [0.46, 2.06]Wald Chi-Square
p-value: 0.322795% CI: [0.67, 3.37]Wald Chi-Square
p-value: 0.5295% CI: [0.39, 1.61]Wald Chi-Square
Secondary
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 1 | 25 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 2 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 3 | 21 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 4 | 16 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 5 | 7 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 6 | 1 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | Missing | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 5 | 9 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 2 | 7 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | Missing | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 4 | 16 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 3 | 20 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 1 | 20 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 3 | 23 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 4 | 19 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 5 | 6 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 6 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | Missing | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 1 | 21 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 2 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 3 | 25 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 4 | 14 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 2 | 7 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 1 | 16 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 5 | 10 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | Missing | 2 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 7 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on Day 3 | 6 | 1 Participants |
p-value: 0.362395% CI: [0.73, 2.35]Wald Chi-Square
p-value: 0.571495% CI: [0.66, 2.12]Wald Chi-Square
p-value: 0.931395% CI: [0.54, 1.75]Wald Chi-Square
Secondary
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 1 | 25 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 2 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 3 | 20 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 4 | 16 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 5 | 7 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 6 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | Missing | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 5 | 9 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 2 | 7 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | Missing | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 4 | 16 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 3 | 20 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 1 | 20 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 3 | 23 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 4 | 19 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 5 | 6 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 6 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | Missing | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 1 | 21 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 2 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 3 | 25 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 4 | 14 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 2 | 7 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 1 | 16 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 5 | 10 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | Missing | 2 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 7 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on Day 3 | 6 | 1 Participants |
p-value: 0.447295% CI: [0.7, 2.25]Wald Chi-Square
p-value: 0.571495% CI: [0.66, 2.12]Wald Chi-Square
p-value: 0.931395% CI: [0.54, 1.75]Wald Chi-Square
Secondary
Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5])
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)
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 1 | 30 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 2 | 6 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 3 | 17 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 4 | 10 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 5 | 7 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 6 | 1 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | Missing | 2 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 6 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 5 | 8 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 2 | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | Missing | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 4 | 14 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 3 | 18 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 1 | 22 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 3 | 15 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 4 | 14 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 5 | 8 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 6 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | Missing | 2 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 1 | 26 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 2 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 3 | 16 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 4 | 14 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 2 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 1 | 27 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 5 | 8 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | Missing | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 7 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary Ordinal Outcome Score on End of Treatment (EOT [Day 5]) | 6 | 1 Participants |
p-value: 0.439895% CI: [0.7, 2.3]Wald Chi-Square
p-value: 0.627795% CI: [0.47, 1.57]Wald Chi-Square
p-value: 0.706995% CI: [0.49, 1.62]Wald Chi-Square
Secondary
Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5)
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)
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 1 | 30 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 2 | 6 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 3 | 16 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 4 | 10 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 5 | 7 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 6 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | Missing | 2 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 6 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 5 | 8 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 2 | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | Missing | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 4 | 14 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 3 | 18 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 1 | 22 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 3 | 15 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 4 | 14 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 5 | 8 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 6 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | Missing | 2 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 1 | 26 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 2 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 3 | 16 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 4 | 14 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 2 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 1 | 27 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 5 | 8 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | Missing | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 7 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on Pulmonary+ Ordinal Outcome Score on EOT (Day 5) | 6 | 1 Participants |
p-value: 0.522295% CI: [0.67, 2.21]Wald Chi-Square
p-value: 0.627795% CI: [0.47, 1.57]Wald Chi-Square
p-value: 0.706995% CI: [0.49, 1.62]Wald Chi-Square
Secondary
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10
The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 (uninfected) to 10 (dead) with higher score indicating clinical progression. The number of participants at each score category is presented.
Time frame: Day 10
Population: All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 9 | 1 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | Missing | 5 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 0 | 3 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 8 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 2 | 26 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 3 | 3 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 1 | 10 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 10 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 4 | 8 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 5 | 11 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 6 | 4 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 1 | 7 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 6 | 2 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 3 | 4 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 8 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 0 | 4 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 5 | 9 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 4 | 16 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 2 | 19 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | Missing | 9 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 10 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 7 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 0 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 1 | 7 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 2 | 22 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 3 | 7 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 4 | 7 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 5 | 14 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 6 | 5 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 8 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 9 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 10 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | Missing | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 5 | 11 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 4 | 13 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 0 | 3 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 9 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 3 | 8 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 2 | 21 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | Missing | 6 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 10 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 7 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 6 | 3 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 1 | 7 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | 8 | 3 Participants |
p-value: 0.634695% CI: [0.6, 2.29]Wald Chi-Square
p-value: 0.759695% CI: [0.46, 1.75]Wald Chi-Square
p-value: 0.887995% CI: [0.49, 1.84]Wald Chi-Square
Secondary
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15
The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 (uninfected) to 10 (dead) with higher score indicating clinical progression. The number of participants at each score category is presented.
Time frame: Day 15
Population: All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 9 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | Missing | 6 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 0 | 10 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 8 | 3 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 2 | 25 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 3 | 7 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 1 | 12 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 10 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 4 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 5 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 6 | 2 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 1 | 12 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 3 | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 8 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 9 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 0 | 8 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 5 | 4 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 4 | 3 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 2 | 25 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | Missing | 12 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 10 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 7 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 0 | 10 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 1 | 9 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 2 | 27 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 3 | 4 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 4 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 5 | 7 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 6 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 8 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 9 | 4 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 10 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | Missing | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 5 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 4 | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 0 | 8 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 9 | 2 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 3 | 8 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 2 | 27 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | Missing | 5 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 10 | 1 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 7 | 1 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 6 | 3 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 1 | 11 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | 8 | 0 Participants |
p-value: 0.600295% CI: [0.55, 2.82]Wald Chi-Square
p-value: 0.473395% CI: [0.58, 3.21]Wald Chi-Square
p-value: 0.62295% CI: [0.38, 1.78]Wald Chi-Square
Secondary
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29
The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 (uninfected) to 10 (dead) with higher score indicating clinical progression. The number of participants at each score category is presented.
Time frame: Day 29
Population: All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 5 | 1 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 3 | 3 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 10 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 4 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 9 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 1 | 4 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | Missing | 10 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 8 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 2 | 24 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 0 | 25 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 1 | 13 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 0 | 17 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 2 | 21 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 3 | 2 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 4 | 2 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 5 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 6 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 8 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 10 | 4 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | Missing | 14 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | Missing | 4 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 10 | 3 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 7 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 9 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 6 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 3 | 7 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 1 | 7 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 4 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 2 | 17 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 8 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 0 | 29 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 5 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 8 | 2 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 6 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 1 | 9 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 7 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 10 | 1 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 5 | 4 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 0 | 22 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | Missing | 6 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 3 | 7 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 9 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 4 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | 2 | 24 Participants |
p-value: 0.787195% CI: [0.28, 2.6]Wald Chi-Square
p-value: 0.959895% CI: [0.31, 3.06]Wald Chi-Square
p-value: 0.66795% CI: [0.27, 2.31]Wald Chi-Square
Secondary
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3
The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 (uninfected) to 10 (dead) with higher score indicating clinical progression. The number of participants at each score category is presented.
Time frame: Day 3
Population: All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 9 | 1 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | Missing | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 0 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 8 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 2 | 1 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 3 | 1 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 1 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 10 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 4 | 27 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 5 | 36 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 6 | 7 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 1 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 6 | 9 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 3 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 8 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 0 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 5 | 36 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 4 | 27 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 2 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | Missing | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 10 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 0 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 1 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 2 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 3 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 4 | 21 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 5 | 42 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 6 | 6 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 8 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 9 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 10 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | Missing | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 5 | 37 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 4 | 24 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 0 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 9 | 1 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 3 | 1 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 2 | 2 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | Missing | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 10 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 7 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 6 | 10 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 1 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | 8 | 0 Participants |
p-value: 0.68395% CI: [0.5, 2.88]Wald Chi-Square
p-value: 195% CI: [0.42, 2.39]Wald Chi-Square
p-value: 0.824495% CI: [0.37, 2.2]Wald Chi-Square
Secondary
Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5)
The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 (uninfected) to 10 (dead) with higher score indicating clinical progression. The number of participants at each score category is presented.
Time frame: EOT (Day 5)
Population: All randomized participants in Part 1 who received ≥1 dose of study drug and have data at the relevant time point are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 9 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | Missing | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 7 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 0 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 8 | 1 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 2 | 3 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 3 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 1 | 2 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 10 | 0 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 4 | 29 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 5 | 27 Participants |
| Part 1: Molnupiravir 200 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 6 | 7 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 1 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 6 | 8 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 3 | 2 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 8 | 1 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 9 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 7 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 0 | 0 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 5 | 31 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 4 | 20 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 2 | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | Missing | 5 Participants |
| Part 1: Molnupiravir 400 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 10 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 7 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 0 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 1 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 2 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 3 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 4 | 27 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 5 | 28 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 6 | 8 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 8 | 1 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 9 | 2 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 10 | 0 Participants |
| Part 1: Molnupiravir 800 mg | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | Missing | 2 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 5 | 26 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 4 | 25 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 0 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 9 | 1 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 3 | 1 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 2 | 9 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | Missing | 3 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 10 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 7 | 0 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 6 | 8 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 1 | 2 Participants |
| Part 1: Placebo | Odds of a More Favorable Response on WHO 11-point Ordinal Outcomes Score on a Scale on EOT (Day 5) | 8 | 0 Participants |
p-value: 0.502295% CI: [0.36, 1.64]Wald Chi-Square
p-value: 0.520495% CI: [0.37, 1.64]Wald Chi-Square
p-value: 0.099195% CI: [0.24, 1.13]Wald Chi-Square