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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4482-002 | Other Identifier | Merck | |
| PHRR201209-003186 | Registry Identifier | PHRR | |
| jRCT2031210148 | Registry Identifier | jRCT | |
| 2020-003368-24 | EudraCT Number |
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This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Molnupiravir 200 mg | Experimental | 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
| Part 1: Molnupiravir 400 mg | Experimental | 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
| Part 1: Molnupiravir 800 mg | Experimental | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
| Part 1: Placebo | Placebo Comparator | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
| Part 2: Molnupiravir 800 mg | Experimental | 800 mg Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total) |
|
| Part 2: Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molnupiravir | Drug | Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis) | The percentage of participants who were hospitalized and/or died through Day 29 is presented. Hospitalization (all cause) is defined as at least 24 hours of acute care in a hospital or similar acute care facility. Death was due to any cause. Any participants with an unknown survival status at Day 29 were treated as failure. The analysis in Part 2 was based on all participants enrolled by the pre-specified futility/early efficacy analysis and was used for demonstration of superiority to placebo for the primary efficacy outcome measure. | Up to 29 days |
| Number of Participants With an Adverse Event (AE) | The number of participants with at least 1 AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to 318 days |
| Number of Participants Who Discontinued Study Intervention Due to an AE | The number of participants who discontinued study intervention due to an AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Medical Group ( Site 1822) | Peoria | Arizona | 85381 | United States | ||
| Ruane Clinical Research Group, Inc. ( Site 2406) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38319179 | Result | Caraco Y, Crofoot GE, Moncada PA, Galustyan AN, Musungaie DB, Payne B, Kovalchuk E, Gonzalez A, Brown ML, Williams-Diaz A, Gao W, Strizki JM, Grobler J, Du J, Assaid CA, Paschke A, Butterton JR, Johnson MG, De Anda C. Phase 2/3 Trial of Molnupiravir for Treatment of Covid-19 in Nonhospitalized Adults. NEJM Evid. 2022 Feb;1(2):EVIDoa2100043. doi: 10.1056/EVIDoa2100043. Epub 2021 Dec 16. | |
| 41125063 |
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Participants were enrolled at 123 study centers in 21 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Molnupiravir 200 mg | 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| FG001 | Part 1: Molnupiravir 400 mg | 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2021 |
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Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
| Placebo | Drug | Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total) |
|
| Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Up to 29 days |
| Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. | Day 3 |
| Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. | EOT (Day 5) |
| Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. | Day 10 |
| Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. | Day 15 |
| Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. | Day 29 |
| Los Angeles |
| California |
| 90036 |
| United States |
| Men's Health Foundation ( Site 1820) | Los Angeles | California | 90069 | United States |
| Carbon Health Technologies Inc ( Site 2505) | North Hollywood | California | 91606 | United States |
| UC Davis Medical Center ( Site 1833) | Sacramento | California | 95817 | United States |
| Emerson Clinical Research Institute ( Site 1828) | Washington D.C. | District of Columbia | 20011 | United States |
| JEM Research Institute ( Site 2508) | Atlantis | Florida | 33462 | United States |
| Midway Immunology and Research Center ( Site 1837) | Ft. Pierce | Florida | 34982 | United States |
| Indago Research & Health Center, Inc ( Site 1809) | Hialeah | Florida | 33012 | United States |
| Advanced Research For Health Improvement LLC ( Site 1816) | Immokalee | Florida | 34142 | United States |
| Advanced Medical Research, LLC ( Site 1864) | Miami | Florida | 33174 | United States |
| Advanced Research For Health Improvement LLC ( Site 1813) | Naples | Florida | 34102 | United States |
| Bliss Healthcare Services ( Site 1847) | Orlando | Florida | 32806 | United States |
| Javara Inc. ( Site 1869) | Albany | Georgia | 31707 | United States |
| IACT Health ( Site 1818) | Columbus | Georgia | 31904 | United States |
| Javara Inc. ( Site 1868) | Fayetteville | Georgia | 30214 | United States |
| Loretto Hospital ( Site 1886) | Chicago | Illinois | 60644 | United States |
| Jadestone Clinical Research, LLC ( Site 2502) | Laurel | Maryland | 20708 | United States |
| Michigan Center of Medical Research ( Site 2500) | Farmington Hills | Michigan | 48334 | United States |
| University of Nebraska Medical Center ( Site 2414) | Omaha | Nebraska | 68198 | United States |
| Amici Clinical Research LLC ( Site 2507) | Raritan | New Jersey | 08869 | United States |
| University of New Mexico, Health Sciences Center ( Site 1819) | Albuquerque | New Mexico | 87131 | United States |
| AXCES Research Group ( Site 2418) | Santa Fe | New Mexico | 87505 | United States |
| Saint Hope Foundation, Inc. ( Site 1830) | Bellaire | Texas | 77401 | United States |
| The Crofoot Research Center, Inc. ( Site 1812) | Houston | Texas | 77098 | United States |
| Javara Inc. ( Site 1866) | Sugar Land | Texas | 77478 | United States |
| Clinical Research Partners, LLC. ( Site 2503) | Richmond | Virginia | 23226 | United States |
| Swedish Medical Center First Hill ( Site 1807) | Seattle | Washington | 98104 | United States |
| Fred Hutchinson Cancer Center ( Site 1829) | Seattle | Washington | 98109 | United States |
| Multicare Health System ( Site 1811) | Spokane | Washington | 99204 | United States |
| Multicare Health System ( Site 1814) | University Place | Washington | 98466 | United States |
| Medical College Of Wisconsin ( Site 2510) | Milwaukee | Wisconsin | 53226 | United States |
| Clinica Independencia ( Site 3400) | Vicente López | Buenos Aires | B1605FRE | Argentina |
| Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401) | Rosario | Santa Fe Province | 2000 | Argentina |
| Chronos Pesquisa Clínica ( Site 0155) | Brasília | Federal District | 72145-424 | Brazil |
| Santa Casa de Misericordia de Belo Horizonte ( Site 0150) | Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
| Hospital de Clinicas da Universidade Federal do Parana ( Site 0154) | Curitiba | Paraná | 80060-900 | Brazil |
| Hospital Tacchini ( Site 0157) | Bento Gonçalves | Rio Grande do Sul | 95700-000 | Brazil |
| FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151) | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Instituto de Infectologia Emilio Ribas ( Site 0153) | São Paulo | 01246-900 | Brazil |
| Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152) | São Paulo | 05403-010 | Brazil |
| Hamilton Medical Research Group ( Site 0207) | Hamilton | Ontario | L8M1K7 | Canada |
| University Health Network - Toronto General Hospital ( Site 0201) | Toronto | Ontario | M5G 2N2 | Canada |
| Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200) | Montreal | Quebec | H2X 3E4 | Canada |
| McGill University Health Centre ( Site 0204) | Montreal | Quebec | H4A 3J1 | Canada |
| Servicios Medicos Urumed ( Site 0307) | Rancagua | Lbtdr Gen Bernardo O Higgins | 2852424 | Chile |
| Clinical Research Chile SpA ( Site 0308) | Valdivia | Los Ríos Region | 5110683 | Chile |
| Clinica Universidad de los Andes ( Site 0302) | Santiago | Region M. de Santiago | 2820945 | Chile |
| Fundacion Arturo Lopez Perez ( Site 0305) | Santiago | Region M. de Santiago | 7500921 | Chile |
| Espacio EME ( Site 0304) | Santiago | Region M. de Santiago | 7770086 | Chile |
| Centro de Investigacion Clinica UC CICUC ( Site 0309) | Santiago | Region M. de Santiago | 8330034 | Chile |
| Clinica Bicentenario Spa ( Site 0306) | Santiago | Region M. de Santiago | 9160000 | Chile |
| Hospital Pablo Tobon Uribe ( Site 0405) | Medellín | Antioquia | 050034 | Colombia |
| Centro Cientifico Asistencial Jose Luis Accini ( Site 0416) | Barranquilla | Atlántico | 080020 | Colombia |
| Clinica de la Costa Ltda. ( Site 0403) | Barranquilla | Atlántico | 080020 | Colombia |
| Fundacion Santa Fe de Bogota ( Site 0412) | Bogotá | Bogota D.C. | 110111 | Colombia |
| Caja de Compensación Familiar CAFAM. Sede Centro de Atención en Salud CAFAM Floresta ( Site 0406) | Bogota | Cundinamarca | 111211 | Colombia |
| Centro de Atencion e Investigacion Medica CAIMED ( Site 0413) | Bogota | Cundinamarca | 111611 | Colombia |
| Oncomedica S.A. ( Site 0407) | Montería | Departamento de Córdoba | 230002 | Colombia |
| Fundacion Cardiovascular de Colombia ( Site 0402) | Bucaramanca | Santander Department | 680003 | Colombia |
| Fundacion Valle del Lili ( Site 0401) | Cali | Valle del Cauca Department | 760032 | Colombia |
| Centro Medico Imbanaco de Cali S.A ( Site 0415) | Cali | Valle del Cauca Department | 760042 | Colombia |
| National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300) | Cairo | Cairo Governorate | 11562 | Egypt |
| Abbassia Chest Hospital ( Site 3340) | Cairo | Cairo Governorate | 11591 | Egypt |
| Abbassia Fever Hospital ( Site 3330) | Cairo | Cairo Governorate | 11591 | Egypt |
| Helwan Fever Hospital ( Site 3350) | Cairo | Cairo Governorate | 12899 | Egypt |
| National Center for allergies and chest ( Site 3320) | Giza | Giza Governorate | 12651 | Egypt |
| Hopital Bichat Claude Bernard ( Site 0503) | Paris | Ain | 75018 | France |
| Hopital Saint Joseph ( Site 0513) | Marseille | Bouches-du-Rhone | 13285 | France |
| Groupe Hospitalier Pellegrin ( Site 0511) | Bordeaux | Gironde | 33000 | France |
| CHU de la Reunion - Groupe Hospitalier Sud ( Site 0514) | Saint-Pierre | La Reunion | 97448 | France |
| C.H.U. de Toulouse Hopital Purpan ( Site 0501) | Toulouse | Midi-Pyrenees | 31059 | France |
| Centre Hospitalier de Tourcoing ( Site 0502) | Tourcoing | Nord | 59208 | France |
| CHU Hopital Saint Antoine ( Site 0505) | Paris | 75012 | France |
| Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504) | Paris | 75013 | France |
| Universitaetsklinikum Frankfurt ( Site 2302) | Frankfurt A Main | Hesse | 60590 | Germany |
| Universitaetsklinikum Essen ( Site 2305) | Essen | North Rhine-Westphalia | 45147 | Germany |
| ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301) | Berlin | 10439 | Germany |
| ICH Study Center GmbH & Co.KG ( Site 2306) | Hamburg | 20146 | Germany |
| Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 2601) | Guatemala City | 01009 | Guatemala |
| Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2600) | Guatemala City | 01015 | Guatemala |
| Hadassah Medical Center. Ein Kerem ( Site 2100) | Jerusalem | 9112001 | Israel |
| Asl Napoli 1 Centro ( Site 0610) | Naples | Napoli | 80145 | Italy |
| Policlinico S. Orsola-Malpighi ( Site 0604) | Bologna | 40138 | Italy |
| IRCCS Ospedale Policlinico San Martino ( Site 0603) | Genova | 16132 | Italy |
| Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606) | Milan | 20122 | Italy |
| Ospedale San Raffaele ( Site 0605) | Milan | 20127 | Italy |
| ASST Fatebenefratelli-Ospedale Sacco ( Site 0601) | Milan | 20157 | Italy |
| Ospedale Niguarda ( Site 0608) | Milan | 20162 | Italy |
| AOU Policlinico Paolo Giaccone ( Site 0609) | Palermo | 90127 | Italy |
| Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 0600) | Roma | 00149 | Italy |
| Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602) | Torino | 10149 | Italy |
| Azienda Sanitaria Universitaria Friuli Centrale -ASU FC ( Site 0607) | Udine | 33100 | Italy |
| Chiba Aoba Municipal Hospital ( Site 0702) | Chiba | 260-0852 | Japan |
| Den-en-chofu family clinic ( Site 0701) | Tokyo | 145-0071 | Japan |
| Center Hospital of the National Center for Global Health and Medicine ( Site 0700) | Tokyo | 162-8655 | Japan |
| Hospital Regional de Alta Especialidad del Bajio ( Site 0807) | León | Guanajuato | 37660 | Mexico |
| Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800) | Guadalajara | Jalisco | 44280 | Mexico |
| CAIMED México ( Site 0814) | Mexico City | Mexico City | 06760 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802) | Mexico City | Mexico City | 14080 | Mexico |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803) | Monterrey | Nuevo León | 64460 | Mexico |
| Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0810) | Cancún | Quintana Roo | 70500 | Mexico |
| Köhler & Milstein Research S.A. de C.V. ( Site 0809) | Mérida | Yucatán | 97070 | Mexico |
| ICARO Investigaciones en Medicina ( Site 0812) | Chihuahua City | 31000 | Mexico |
| Oaxaca Site Management Organization S.C. ( Site 0811) | Oaxaca City | 68000 | Mexico |
| Clinical Research Institute S.C. ( Site 0813) | Tlalnepantla | 54055 | Mexico |
| Arké SMO S.A de C.V ( Site 0808) | Veracruz | 91910 | Mexico |
| Lung Center of the Philippines ( Site 0902) | Quezon City | National Capital Region | 1100 | Philippines |
| Quirino Memorial Medical Center ( Site 0903) | Quezon City | National Capital Region | 1109 | Philippines |
| Krakowskie Centrum Medyczne Sp. z o.o ( Site 1008) | Krakow | Lesser Poland Voivodeship | 31-501 | Poland |
| Centrum Medyczne Pulawska Sp. z o.o. ( Site 1007) | Piaseczno | Masovian Voivodeship | 05-500 | Poland |
| Centrum Medyczne MEDYK Sp. z o.o. Sp.k. ( Site 1009) | Rzeszów | Podkarpackie Voivodeship | 35-326 | Poland |
| NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006) | Lodz | Łódź Voivodeship | 90-302 | Poland |
| Central Scientific Research Institute of Epidemiology ( Site 1104) | Moscow | Moscow | 111123 | Russia |
| Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1122) | Moscow | Moscow | 115419 | Russia |
| Hadassah Medical LTD ( Site 1124) | Moscow | Moscow | 121205 | Russia |
| Central Clinical Hospital with Polyclinic ( Site 1105) | Moscow | Moscow | 121359 | Russia |
| City Hospital No.33 of Leninsky ( Site 1127) | Nizhny Novgorod | Nizhny Novgorod Oblast | 603076 | Russia |
| City Polyclinic N44 ( Site 1130) | Saint Petersburg | Sankt-Peterburg | 192071 | Russia |
| Strategic Medical System LLC ( Site 1114) | Saint Petersburg | Sankt-Peterburg | 192148 | Russia |
| St.Petersburg Outpatient Clinic No. 109 ( Site 1119) | Saint Petersburg | Sankt-Peterburg | 192289 | Russia |
| SPb SBHI City outpatient clinic 112 ( Site 1128) | Saint Petersburg | Sankt-Peterburg | 195427 | Russia |
| Medical Research Institute LLC ( Site 1116) | Saint Petersburg | Sankt-Peterburg | 196084 | Russia |
| Limited liability company "Scientific research center Eco-safety" ( Site 1117) | Saint Petersburg | Sankt-Peterburg | 196143 | Russia |
| Smorodintsev Research Institute of Influenza ( Site 1129) | Saint Petersburg | Sankt-Peterburg | 197376 | Russia |
| SPb SBHI City outpatient clinic 4 ( Site 1131) | Saint Petersburg | Sankt-Peterburg | 199406 | Russia |
| Smolensk State Medical University ( Site 1110) | Smolensk | Smolensk Oblast | 214019 | Russia |
| Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100) | Kazan' | Tatarstan, Respublika | 420140 | Russia |
| IATROS International ( Site 1212) | Bloemfontein | Free State | 9300 | South Africa |
| Right To Care Research - Esizayo ( Site 1229) | Johannesburg | Gauteng | 2087 | South Africa |
| Mzansi Ethical Research Centre ( Site 1225) | Mpumalanga | Gauteng | 1055 | South Africa |
| Jongaie Research ( Site 1223) | Pretoria West | Gauteng | 0183 | South Africa |
| Wits Baragwanath Clinical Trial Site ( Site 1214) | Soweto | Gauteng | 2013 | South Africa |
| Enhancing Care Foundation-DICRS ( Site 1216) | Durban | KwaZulu-Natal | 4091 | South Africa |
| Limpopo Clinical Research Initiative ( Site 1227) | Thabazimbi | Limpopo | 0380 | South Africa |
| TREAD Research ( Site 1211) | Cape Town | Western Cape | 7500 | South Africa |
| Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219) | Cape Town | Western Cape | 7925 | South Africa |
| Be Part Yoluntu Centre ( Site 1218) | Paarl | Western Cape | 7626 | South Africa |
| Paarl Research Centre ( Site 1228) | Paarl | Western Cape | 7646 | South Africa |
| Clinical Projects Research Centre ( Site 1215) | Worcester | Western Cape | 6850 | South Africa |
| CAP Centelles ( Site 1308) | Centelles | Barcelona | 08540 | Spain |
| Fundacion Hospital Alcorcon de Madrid ( Site 1314) | Alcorcón | Madrid | 28922 | Spain |
| Hospital General Universitario Gregorio Maranon ( Site 1302) | Madrid | Madrid, Comunidad de | 28007 | Spain |
| CAP Sardenya - Barcelona ( Site 1307) | Barcelona | 08025 | Spain |
| Hospital Clinic ( Site 1304) | Barcelona | 08036 | Spain |
| Hospital Universitari Germans Trias i Pujol ( Site 1303) | Barcelona | 08916 | Spain |
| Hospital Universitario Infanta Leonor ( Site 1310) | Madrid | 28031 | Spain |
| Hospital Universitario Ramon y Cajal ( Site 1301) | Madrid | 28034 | Spain |
| Hospital Universitario La Paz ( Site 1300) | Madrid | 28046 | Spain |
| Karolinska Universitetssjukhuset Solna ( Site 1400) | Stockholm | Stockholm County | 113 61 | Sweden |
| ClinSmart Sweden AB.Uppsala ( Site 1402) | Uppsala | Uppsala County | 752 37 | Sweden |
| Sahlgrenska Universitetssjukhuset Ostra ( Site 1401) | Gothenburg | Västra Götaland County | 416 85 | Sweden |
| National Taiwan University Hospital ( Site 3100) | Taipei | 100 | Taiwan |
| Taoyuan General Hospital ( Site 3101) | Taoyuan | 33004 | Taiwan |
| Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605) | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76007 | Ukraine |
| CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604) | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603) | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 1621) | Kharkiv | Kharkiv Oblast | 61002 | Ukraine |
| PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 1627) | Kharkiv | Kharkiv Oblast | 61172 | Ukraine |
| Limited Liability Company Medical center Healthy Happy ( Site 1625) | Kyiv | Kyivska Oblast | 01033 | Ukraine |
| LLC "Adonis plus" ( Site 1619) | Kyiv | Kyivska Oblast | 02002 | Ukraine |
| Kyiv railway clinical hospital 2 of Branch Health center ( Site 1602) | Kyiv | Kyivska Oblast | 03049 | Ukraine |
| ARTEM. State Holding Company ( Site 1618) | Kyiv | Kyivska Oblast | 04050 | Ukraine |
| Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 1622) | Lviv | Lviv Oblast | 79011 | Ukraine |
| MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 1626) | Odesa | Odesa Oblast | 65025 | Ukraine |
| Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614) | Poltava | Poltava Oblast | 36011 | Ukraine |
| Medical Center Health Clinic ( Site 1623) | Vinnytsia | Vinnytsia Oblast | 21009 | Ukraine |
| The Adam Practice ( Site 1708) | Poole | Dorset | BH15 2HX | United Kingdom |
| Accellacare South London Quality Research Centre ( Site 1709) | Orpington | Kent | BR5 3QG | United Kingdom |
| Royal Free London NHS Foundation Trust ( Site 1700) | London | London, City of | NW3 2QG | United Kingdom |
| King's College Hospital ( Site 1707) | London | London, City of | SE5 9RS | United Kingdom |
| Layton Medical Centre ( Site 1705) | Blackpool | FY3 7EN | United Kingdom |
| Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704) | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Derived |
| Johnson MG, Strizki JM, Hilbert DW, Zhang Y, Carmelitano P, Brown ML, Wolf DJ, Paschke A, De Anda CS. Impact of baseline humoral immunity on treatment outcomes with molnupiravir in the MOVe-OUT randomized, controlled trial. Virology. 2026 Jan;613:110710. doi: 10.1016/j.virol.2025.110710. Epub 2025 Oct 9. |
| 40025641 | Derived | Caraco Y, Johnson MG, Chiarappa JA, Maas BM, Stone JA, Rizk ML, Vesnesky M, Strizki JM, Williams-Diaz A, Brown ML, Carmelitano P, Wan H, Pedley A, Chawla A, Wolf DJ, Grobler JA, Paschke A, De Anda C. Impact of differences between interim and post-interim analysis populations on outcomes of a group sequential trial: Example of the MOVe-OUT study. Clin Trials. 2025 Jun;22(3):312-324. doi: 10.1177/17407745251313925. Epub 2025 Mar 2. |
| 37995070 | Derived | Strizki JM, Grobler JA, Murgolo N, Fridman A, Johnson MG, Du J, Carmelitano P, Brown ML, Paschke A, De Anda C. Virologic Outcomes with Molnupiravir in Non-hospitalized Adult Patients with COVID-19 from the Randomized, Placebo-Controlled MOVe-OUT Trial. Infect Dis Ther. 2023 Dec;12(12):2725-2743. doi: 10.1007/s40121-023-00891-1. Epub 2023 Nov 23. |
| 37466374 | Derived | Guan Y, Puenpatom A, Johnson MG, Zhang Y, Zhao Y, Surber J, Weinberg A, Brotons C, Kozlov R, Lopez R, Coetzee K, Santiaguel J, Du J, Williams-Diaz A, Brown M, Paschke A, De Anda C, Norquist JM. Impact of Molnupiravir Treatment on Patient-Reported COVID-19 Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo-Controlled Trial. Clin Infect Dis. 2023 Nov 30;77(11):1521-1530. doi: 10.1093/cid/ciad409. |
| 37017631 | Derived | Chawla A, Birger R, Wan H, Cao Y, Maas BM, Paschke A, De Anda C, Rizk ML, Stone JA. Factors Influencing COVID-19 Risk: Insights From Molnupiravir Exposure-Response Modeling of Clinical Outcomes. Clin Pharmacol Ther. 2023 Jun;113(6):1337-1345. doi: 10.1002/cpt.2895. Epub 2023 Apr 27. |
| 36648627 | Derived | Johnson MG, Strizki JM, Brown ML, Wan H, Shamsuddin HH, Ramgopal M, Florescu DF, Delobel P, Khaertynova I, Flores JF, Fouche LF, Chang SC, Williams-Diaz A, Du J, Grobler JA, Paschke A, De Anda C. Molnupiravir for the treatment of COVID-19 in immunocompromised participants: efficacy, safety, and virology results from the phase 3 randomized, placebo-controlled MOVe-OUT trial. Infection. 2023 Oct;51(5):1273-1284. doi: 10.1007/s15010-022-01959-9. Epub 2023 Jan 17. |
| 35667065 | Derived | Johnson MG, Puenpatom A, Moncada PA, Burgess L, Duke ER, Ohmagari N, Wolf T, Bassetti M, Bhagani S, Ghosn J, Zhang Y, Wan H, Williams-Diaz A, Brown ML, Paschke A, De Anda C. Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 : A Randomized, Placebo-Controlled Trial. Ann Intern Med. 2022 Aug;175(8):1126-1134. doi: 10.7326/M22-0729. Epub 2022 Jun 7. |
| 34914868 | Derived | Jayk Bernal A, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, Martin-Quiros A, Caraco Y, Williams-Diaz A, Brown ML, Du J, Pedley A, Assaid C, Strizki J, Grobler JA, Shamsuddin HH, Tipping R, Wan H, Paschke A, Butterton JR, Johnson MG, De Anda C; MOVe-OUT Study Group. Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med. 2022 Feb 10;386(6):509-520. doi: 10.1056/NEJMoa2116044. Epub 2021 Dec 16. |
| FG002 | Part 1: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| FG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| FG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| FG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Molnupiravir 200 mg | 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| BG001 | Part 1: Molnupiravir 400 mg | 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| BG002 | Part 1: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| BG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| BG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| BG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Time from Symptom Onset to Randomization (Part 1) | Randomization of participants in Part 1 of this study was stratified by the time from symptom onset prior to the day of randomization (≤5 days or >5 days). | Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only. | Count of Participants | Participants |
| |||||||||
| At Increased Risk of Severe Illness from Coronavirus Disease (COVID-19) (Part 1) | Randomization of participants in Part 1 of this study was stratified by whether the participant was at an increased risk of severe illness from COVID-19 (Yes or No). | Analysis population consisted of all randomized participants in Part 1. Per protocol, this stratification factor was applicable to Part 1 of the study only. | Count of Participants | Participants |
| |||||||||
| Time from Symptom Onset to Randomization (Part 2) | Randomization of participants in Part 2 of this study was stratified by the time from symptom onset prior to the day of randomization (≤3 days or >3 days). | Analysis population consisted of all randomized participants in Part 2. Per protocol, this stratification factor was applicable to Part 2 of the study only. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis) | The percentage of participants who were hospitalized and/or died through Day 29 is presented. Hospitalization (all cause) is defined as at least 24 hours of acute care in a hospital or similar acute care facility. Death was due to any cause. Any participants with an unknown survival status at Day 29 were treated as failure. The analysis in Part 2 was based on all participants enrolled by the pre-specified futility/early efficacy analysis and was used for demonstration of superiority to placebo for the primary efficacy outcome measure. | All randomized participants in Part 1 who received at least one dose of study intervention and were not hospitalized prior to the administration of the first dose of study intervention, and all randomized participants in Part 2 who had reached Day 29 by the pre-specified futility/early efficacy analysis who received at least one dose of study intervention and were not hospitalized prior to the administration of the first dose of study intervention, were analyzed. | Posted | Number | Percentage of Participants | Up to 29 days |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | All randomized participants who received at least one dose of study treatment were analyzed. | Posted | Count of Participants | Participants | Up to 318 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Discontinued Study Intervention Due to an AE | The number of participants who discontinued study intervention due to an AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All randomized participants who received at least one dose of study treatment were analyzed. | Posted | Count of Participants | Participants | Up to 5 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (cough) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (sore throat) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (nasal congestion) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (rhinorrhea) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (shortness of breath or difficulty breathing) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (muscles or body aches) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (fatigue) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (feeling hot or feverish) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (chills) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (headache) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (nausea) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (vomiting) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (diarrhea) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (loss of taste) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and had the corresponding sign or symptom (loss of smell) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (cough) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (sore throat) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (nasal congestion) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (rhinorrhea) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (shortness of breath or difficulty breathing) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (muscle or body aches) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (fatigue) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (feeling hot or feverish) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (chills) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (headache) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (nausea) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (vomiting) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (diarrhea) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (loss of taste) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell | Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis. | Per protocol, all randomized participants who received at least one dose of study intervention and reported absent or non-severe symptoms for the targeted sign/symptom (loss of smell) at the time of randomization were analyzed. | Posted | Median | 95% Confidence Interval | Days | Up to 29 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. | Per protocol, all randomized participants who received at least one dose of study treatment and had non-missing ordinal scale data at the time point assessed were analyzed. 38 participants with missing ordinal scale data were not included in the analysis. | Posted | Count of Participants | Participants | Day 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5]) | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. | Per protocol, all randomized participants who received at least one dose of study treatment and had non-missing ordinal scale data at the time point assessed were analyzed. 40 participants with missing ordinal scale data were not included in the analysis. | Posted | Count of Participants | Participants | EOT (Day 5) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. | Per protocol, all randomized participants who received at least one dose of study treatment and had non-missing ordinal scale data at the time point assessed were analyzed. 80 participants with missing ordinal scale data were not included in the analysis. | Posted | Count of Participants | Participants | Day 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. | Per protocol, all randomized participants who received at least one dose of study treatment and had non-missing ordinal scale data at the time point assessed were analyzed. 87 participants with missing ordinal scale data were not included in the analysis. | Posted | Count of Participants | Participants | Day 15 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29 | The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented. | Per protocol, all randomized participants who received at least one dose of study treatment and had non-missing ordinal scale data at the time point assessed were analyzed. 139 participants with missing ordinal scale data were not included in the analysis. | Posted | Count of Participants | Participants | Day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 | The percentage of participants who were hospitalized and/or died through Day 29 is presented. Hospitalization (all cause) is defined as at least 24 hours of acute care in a hospital or similar acute care facility. Death was due to any cause. Any participants with an unknown survival status at Day 29 were treated as failure. This analysis was based on all randomized participants in Part 2 who received at least one dose of study treatment, were not hospitalized prior to the administration of the first dose of study intervention, and had reached Day 29 post treatment. | All randomized participants in Part 2 who received at least one dose of study intervention and were not hospitalized prior to the administration of the first dose of study intervention were analyzed. | Posted | Number | Percentage of Participants | Up to 29 days |
|
|
Up to 318 days
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: MK-4482 200 mg | 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 0 | 75 | 1 | 74 | 6 | 74 |
| EG001 | Part 1: MK-4482 400 mg | 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 0 | 77 | 3 | 77 | 4 | 77 |
| EG002 | Part 1: MK-4482 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 0 | 76 | 4 | 74 | 5 | 74 |
| EG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 1 | 74 | 5 | 74 | 9 | 74 |
| EG004 | Part 2: MK-4482 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 4 | 716 | 51 | 710 | 38 | 710 |
| EG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) | 16 | 717 | 67 | 701 | 38 | 701 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Peritonsillitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombosis mesenteric vessel | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Apr 26, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656703 | molnupiravir |
Not provided
Not provided
Not provided
|
|
|
|
|
| >5 Days |
|
|
|
| No |
|
|
|
| > 3 days |
|
|
| Difference in Rates % |
| -1.5 |
| 2-Sided |
| 95 |
| -9.9 |
| 6.2 |
| Other |
Difference in rates % and associated CIs were based on the Miettinen & Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure. |
| Differences in Rates % | -1.3 | 2-Sided | 95 | -9.6 | 6.4 | Other | Difference in rates % and associated CIs were based on the Miettinen & Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure. |
| Miettinen & Nurminen | 0.0012 | Difference in Rates % | -6.8 | 2-Sided | 95 | -11.3 | -2.4 | Superiority | Difference in rates %, associated CIs, and p-value were based on the Miettinen & Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure. |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 | Part 1: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| Part 1: Placebo |
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| OG003 |
| Part 1: Placebo |
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| Part 1: Placebo |
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| Part 1: Placebo |
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
|
|
|
| Part 1: Placebo |
Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG004 | Part 2: Molnupiravir 800 mg | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| OG005 | Part 2: Placebo | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
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| Participants |
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