Coronavirus Disease (COVID-19) Clinical Trial
Official title:
A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.
| Verified date | May 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 1735 |
| Est. completion date | May 5, 2022 |
| Est. primary completion date | May 5, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Has documentation of laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection =5 days prior to the day of randomization. PCR is the preferred method; however with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (RNA) or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed. - Had initial onset of signs/symptoms attributable to COVID-19 for =5 days prior to the day of randomization and at least 1 of the following sign/symptom attributable to COVID-19 on the day of randomization. - Has mild or moderate COVID-19. - Has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19. - Males agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: Either abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception. - Females are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for at least 4 days after the last dose of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention. Exclusion Criteria: - Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization. - Is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2 by the Modification of Diet in Renal Disease (MDRD) equation. - Has any of the following conditions: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL (regardless of CD4 count) or an AIDS-defining illness in the past 6 months, participants with HIV may only be enrolled if on a stable antiretroviral therapy regimen; a neutrophilic granulocyte absolute count <500/mm^3. - Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening. - Has a platelet count <100,000/µL or received a platelet transfusion in the 5 days prior to randomization. - Is taking or is anticipated to require any prohibited therapies. - Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics. - Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. - Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401) | Rosario | Santa Fe |
| Argentina | Clinica Independencia ( Site 3400) | Vicente Lopez | Buenos Aires |
| Brazil | Santa Casa de Misericordia de Belo Horizonte ( Site 0150) | Belo Horizonte | Minas Gerais |
| Brazil | Hospital Tacchini ( Site 0157) | Bento Goncalves | Rio Grande Do Sul |
| Brazil | Chronos Pesquisa Clínica ( Site 0155) | Brasilia | Distrito Federal |
| Brazil | Hospital de Clinicas da Universidade Federal do Parana ( Site 0154) | Curitiba | Parana |
| Brazil | FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151) | Sao Jose do Rio Preto | Sao Paulo |
| Brazil | Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152) | Sao Paulo | |
| Brazil | Instituto de Infectologia Emilio Ribas ( Site 0153) | Sao Paulo | |
| Canada | Hamilton Medical Research Group ( Site 0207) | Hamilton | Ontario |
| Canada | Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200) | Montreal | Quebec |
| Canada | McGill University Health Centre ( Site 0204) | Montreal | Quebec |
| Canada | University Health Network - Toronto General Hospital ( Site 0201) | Toronto | Ontario |
| Chile | Servicios Medicos Urumed ( Site 0307) | Rancagua | Lbtdr Gen Bernardo O Higgins |
| Chile | Centro de Investigacion Clinica UC CICUC ( Site 0309) | Santiago | Region M. De Santiago |
| Chile | Clinica Bicentenario Spa ( Site 0306) | Santiago | Region M. De Santiago |
| Chile | Clinica Universidad de los Andes ( Site 0302) | Santiago | Region M. De Santiago |
| Chile | Espacio EME ( Site 0304) | Santiago | Region M. De Santiago |
| Chile | Fundacion Arturo Lopez Perez ( Site 0305) | Santiago | Region M. De Santiago |
| Chile | Clinical Research Chile SpA ( Site 0308) | Valdivia | Los Rios |
| Colombia | Centro Cientifico Asistencial Jose Luis Accini ( Site 0416) | Barranquilla | Atlantico |
| Colombia | Clinica de la Costa Ltda. ( Site 0403) | Barranquilla | Atlantico |
| Colombia | Caja de Compensación Familiar CAFAM. Sede Centro de Atención en Salud CAFAM Floresta ( Site 0406) | Bogota | Cundinamarca |
| Colombia | Centro de Atencion e Investigacion Medica CAIMED ( Site 0413) | Bogota | Cundinamarca |
| Colombia | Fundacion Santa Fe de Bogota ( Site 0412) | Bogota | Distrito Capital De Bogota |
| Colombia | Fundacion Cardiovascular de Colombia ( Site 0402) | Bucaramanca | Santander |
| Colombia | Centro Medico Imbanaco de Cali S.A ( Site 0415) | Cali | Valle Del Cauca |
| Colombia | Fundacion Valle del Lili ( Site 0401) | Cali | Valle Del Cauca |
| Colombia | Hospital Pablo Tobon Uribe ( Site 0405) | Medellin | Antioquia |
| Colombia | Oncomedica S.A. ( Site 0407) | Monteria | Cordoba |
| Egypt | Abbassia Chest Hospital ( Site 3340) | Cairo | Al Qahirah |
| Egypt | Abbassia Fever Hospital ( Site 3330) | Cairo | Al Qahirah |
| Egypt | Helwan Fever Hospital ( Site 3350) | Cairo | Al Qahirah |
| Egypt | National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300) | Cairo | Al Qahirah |
| Egypt | National Center for allergies and chest ( Site 3320) | Giza | Al Jizah |
| France | Groupe Hospitalier Pellegrin ( Site 0511) | Bordeaux | Gironde |
| France | Hopital Saint Joseph ( Site 0513) | Marseille | Bouches-du-Rhone |
| France | CHU Hopital Saint Antoine ( Site 0505) | Paris | |
| France | Hopital Bichat Claude Bernard ( Site 0503) | Paris | Ain |
| France | Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504) | Paris | |
| France | CHU de la Reunion - Groupe Hospitalier Sud ( Site 0514) | Saint Pierre Cedex | La Reunion |
| France | C.H.U. de Toulouse Hopital Purpan ( Site 0501) | Toulouse | Midi-Pyrenees |
| France | Centre Hospitalier de Tourcoing ( Site 0502) | Tourcoing | Nord |
| Germany | ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301) | Berlin | |
| Germany | Universitaetsklinikum Essen ( Site 2305) | Essen | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Frankfurt ( Site 2302) | Frankfurt a main | Hessen |
| Germany | ICH Study Center GmbH & Co.KG ( Site 2306) | Hamburg | |
| Guatemala | Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 2601) | Guatemala | |
| Guatemala | Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2600) | Guatemala | |
| Israel | Hadassah Medical Center. Ein Kerem ( Site 2100) | Jerusalem | |
| Italy | Policlinico S. Orsola-Malpighi ( Site 0604) | Bologna | |
| Italy | IRCCS Ospedale Policlinico San Martino ( Site 0603) | Genova | |
| Italy | ASST Fatebenefratelli-Ospedale Sacco ( Site 0601) | Milano | |
| Italy | Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606) | Milano | |
| Italy | Ospedale Niguarda ( Site 0608) | Milano | |
| Italy | Ospedale San Raffaele ( Site 0605) | Milano | |
| Italy | Asl Napoli 1 Centro ( Site 0610) | Napoles | Napoli |
| Italy | AOU Policlinico Paolo Giaccone ( Site 0609) | Palermo | |
| Italy | Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 0600) | Roma | |
| Italy | Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602) | Torino | |
| Italy | Azienda Sanitaria Universitaria Friuli Centrale -ASU FC ( Site 0607) | Udine | |
| Japan | Chiba Aoba Municipal Hospital ( Site 0702) | Chiba | |
| Japan | Center Hospital of the National Center for Global Health and Medicine ( Site 0700) | Tokyo | |
| Japan | Den-en-chofu family clinic ( Site 0701) | Tokyo | |
| Mexico | Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0810) | Cancun | Quintana Roo |
| Mexico | ICARO Investigaciones en Medicina ( Site 0812) | Chihuahua | |
| Mexico | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802) | Ciudad de mexico | Distrito Federal |
| Mexico | Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800) | Guadalajara | Jalisco |
| Mexico | Hospital Regional de Alta Especialidad del Bajio ( Site 0807) | Leon | Guanajuato |
| Mexico | Köhler & Milstein Research S.A. de C.V. ( Site 0809) | Merida | Yucatan |
| Mexico | CAIMED México ( Site 0814) | Mexico City | Distrito Federal |
| Mexico | Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803) | Monterrey | Nuevo Leon |
| Mexico | Oaxaca Site Management Organization S.C. ( Site 0811) | Oaxaca | |
| Mexico | Clinical Research Institute S.C. ( Site 0813) | Tlalnepantla de Baz | |
| Mexico | Arké SMO S.A de C.V ( Site 0808) | Veracruz | |
| Philippines | Lung Center of the Philippines ( Site 0902) | Quezon City | National Capital Region |
| Philippines | Quirino Memorial Medical Center ( Site 0903) | Quezon City | National Capital Region |
| Poland | Krakowskie Centrum Medyczne Sp. z o.o ( Site 1008) | Krakow | Malopolskie |
| Poland | NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006) | Lodz | Lodzkie |
| Poland | Centrum Medyczne Pulawska Sp. z o.o. ( Site 1007) | Piaseczno | Mazowieckie |
| Poland | Centrum Medyczne MEDYK Sp. z o.o. Sp.k. ( Site 1009) | Rzeszow | Podkarpackie |
| Russian Federation | Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100) | Kazan | Tatarstan, Respublika |
| Russian Federation | Central Clinical Hospital with Polyclinic ( Site 1105) | Moscow | Moskva |
| Russian Federation | Central Scientific Research Institute of Epidemiology ( Site 1104) | Moscow | Moskva |
| Russian Federation | Hadassah Medical LTD ( Site 1124) | Moscow | Moskva |
| Russian Federation | Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1122) | Moscow | Moskva |
| Russian Federation | City Hospital No.33 of Leninsky ( Site 1127) | Nizhny Novgorod | Nizhegorodskaya Oblast |
| Russian Federation | Medical Research Institute LLC ( Site 1116) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | Smorodintsev Research Institute of Influenza ( Site 1129) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | SPb SBHI City outpatient clinic 112 ( Site 1128) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | SPb SBHI City outpatient clinic 4 ( Site 1131) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | Limited liability company "Scientific research center Eco-safety" ( Site 1117) | Saint-Petersburg | Sankt-Peterburg |
| Russian Federation | St.Petersburg Outpatient Clinic No. 109 ( Site 1119) | Saint-Petersburg | Sankt-Peterburg |
| Russian Federation | Strategic Medical System LLC ( Site 1114) | Saint-Petersburg | Sankt-Peterburg |
| Russian Federation | Smolensk State Medical University ( Site 1110) | Smolensk | Smolenskaya Oblast |
| Russian Federation | City Polyclinic N44 ( Site 1130) | St.Petersburg | Sankt-Peterburg |
| South Africa | IATROS International ( Site 1212) | Bloemfontein | Free State |
| South Africa | Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219) | Cape Town | Western Cape |
| South Africa | TREAD Research ( Site 1211) | Cape Town | Western Cape |
| South Africa | Enhancing Care Foundation-DICRS ( Site 1216) | Durban | Kwazulu-Natal |
| South Africa | Right To Care Research - Esizayo ( Site 1229) | Johannesburg | Gauteng |
| South Africa | Mzansi Ethical Research Centre ( Site 1225) | Mpumalanga | Gauteng |
| South Africa | Be Part Yoluntu Centre ( Site 1218) | Paarl | Western Cape |
| South Africa | Paarl Research Centre ( Site 1228) | Paarl | Western Cape |
| South Africa | Jongaie Research ( Site 1223) | Pretoria-West | Gauteng |
| South Africa | Wits Baragwanath Clinical Trial Site ( Site 1214) | Soweto | Gauteng |
| South Africa | Limpopo Clinical Research Initiative ( Site 1227) | Thabazimbi | Limpopo |
| South Africa | Clinical Projects Research Centre ( Site 1215) | Worcester | Western Cape |
| Spain | Fundacion Hospital Alcorcon de Madrid ( Site 1314) | Alcorcon | Madrid |
| Spain | CAP Sardenya - Barcelona ( Site 1307) | Barcelona | |
| Spain | Hospital Clinic ( Site 1304) | Barcelona | |
| Spain | Hospital Universitari Germans Trias i Pujol ( Site 1303) | Barcelona | |
| Spain | CAP Centelles ( Site 1308) | Centelles | Barcelona |
| Spain | Hospital General Universitario Gregorio Maranon ( Site 1302) | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario Infanta Leonor ( Site 1310) | Madrid | |
| Spain | Hospital Universitario La Paz ( Site 1300) | Madrid | |
| Spain | Hospital Universitario Ramon y Cajal ( Site 1301) | Madrid | |
| Sweden | Sahlgrenska Universitetssjukhuset Ostra ( Site 1401) | Goteborg | Vastra Gotalands Lan |
| Sweden | Karolinska Universitetssjukhuset Solna ( Site 1400) | Stockholm | Stockholms Lan |
| Sweden | ClinSmart Sweden AB.Uppsala ( Site 1402) | Uppsala | Uppsala Lan |
| Taiwan | National Taiwan University Hospital ( Site 3100) | Taipei | |
| Taiwan | Taoyuan General Hospital ( Site 3101) | Taoyuan | |
| Ukraine | CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604) | Ivano-Frankivsk | Ivano-Frankivska Oblast |
| Ukraine | Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605) | Ivano-Frankivsk | Ivano-Frankivska Oblast |
| Ukraine | MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603) | Ivano-Frankivsk | Ivano-Frankivska Oblast |
| Ukraine | Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 1621) | Kharkiv | Kharkivska Oblast |
| Ukraine | PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 1627) | Kharkiv | Kharkivska Oblast |
| Ukraine | ARTEM. State Holding Company ( Site 1618) | Kyiv | Kyivska Oblast |
| Ukraine | Kyiv railway clinical hospital 2 of Branch Health center ( Site 1602) | Kyiv | Kyivska Oblast |
| Ukraine | Limited Liability Company Medical center Healthy Happy ( Site 1625) | Kyiv | Kyivska Oblast |
| Ukraine | LLC "Adonis plus" ( Site 1619) | Kyiv | Kyivska Oblast |
| Ukraine | Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 1622) | Lviv | Lvivska Oblast |
| Ukraine | MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 1626) | Odessa | Odeska Oblast |
| Ukraine | Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614) | Poltava | Poltavska Oblast |
| Ukraine | Medical Center Health Clinic ( Site 1623) | Vinnytsia | Vinnytska Oblast |
| United Kingdom | Layton Medical Centre ( Site 1705) | Blackpool | |
| United Kingdom | King's College Hospital ( Site 1707) | London | London, City Of |
| United Kingdom | Royal Free London NHS Foundation Trust ( Site 1700) | London | London, City Of |
| United Kingdom | Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704) | Newcastle upon Tyne | |
| United Kingdom | Accellacare South London Quality Research Centre ( Site 1709) | Orpington | Kent |
| United Kingdom | The Adam Practice ( Site 1708) | Poole | Dorset |
| United States | Javara Inc. ( Site 1869) | Albany | Georgia |
| United States | University of New Mexico, Health Sciences Center ( Site 1819) | Albuquerque | New Mexico |
| United States | JEM Research Institute ( Site 2508) | Atlantis | Florida |
| United States | Saint Hope Foundation, Inc. ( Site 1830) | Bellaire | Texas |
| United States | Loretto Hospital ( Site 1886) | Chicago | Illinois |
| United States | IACT Health ( Site 1818) | Columbus | Georgia |
| United States | Michigan Center of Medical Research ( Site 2500) | Farmington Hills | Michigan |
| United States | Javara Inc. ( Site 1868) | Fayetteville | Georgia |
| United States | Midway Immunology and Research Center ( Site 1837) | Fort Pierce | Florida |
| United States | Indago Research & Health Center, Inc ( Site 1809) | Hialeah | Florida |
| United States | The Crofoot Research Center, Inc. ( Site 1812) | Houston | Texas |
| United States | Advanced Research For Health Improvement LLC ( Site 1816) | Immokalee | Florida |
| United States | Jadestone Clinical Research, LLC ( Site 2502) | Laurel | Maryland |
| United States | Men's Health Foundation ( Site 1820) | Los Angeles | California |
| United States | Ruane Clinical Research Group, Inc. ( Site 2406) | Los Angeles | California |
| United States | Advanced Medical Research, LLC ( Site 1864) | Miami | Florida |
| United States | Medical College Of Wisconsin ( Site 2510) | Milwaukee | Wisconsin |
| United States | Advanced Research For Health Improvement LLC ( Site 1813) | Naples | Florida |
| United States | Carbon Health Technologies Inc ( Site 2505) | North Hollywood | California |
| United States | University of Nebraska Medical Center ( Site 2414) | Omaha | Nebraska |
| United States | Bliss Healthcare Services ( Site 1847) | Orlando | Florida |
| United States | Phoenix Medical Group ( Site 1822) | Peoria | Arizona |
| United States | Amici Clinical Research LLC ( Site 2507) | Raritan | New Jersey |
| United States | Clinical Research Partners, LLC. ( Site 2503) | Richmond | Virginia |
| United States | UC Davis Medical Center ( Site 1833) | Sacramento | California |
| United States | AXCES Research Group ( Site 2418) | Santa Fe | New Mexico |
| United States | Fred Hutchinson Cancer Center ( Site 1829) | Seattle | Washington |
| United States | Swedish Medical Center First Hill ( Site 1807) | Seattle | Washington |
| United States | Multicare Health System ( Site 1811) | Spokane | Washington |
| United States | Javara Inc. ( Site 1866) | Sugar Land | Texas |
| United States | Multicare Health System ( Site 1814) | University Place | Washington |
| United States | Emerson Clinical Research Institute ( Site 1828) | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Ukraine, United Kingdom,
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, for the MOVe-OUT Study Group. Phase 2
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 29 |
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