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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04575597
Other study ID # 4482-002
Secondary ID MK-4482-002PHRR2
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date October 19, 2020
Est. completion date May 5, 2022

Study information

Verified date May 2023
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Molnupiravir
Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Placebo
Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

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, 

References & Publications (1)

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

Outcome

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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