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
Drug: Molnupiravir
Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Other Name: MK-4482
Drug: Placebo
Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
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.
Phoenix Medical Group ( Site 1822)
Peoria, Arizona, United States
Ruane Clinical Research Group, Inc. ( Site 2406)
Los Angeles, California, United States
Men's Health Foundation ( Site 1820)
Los Angeles, California, United States
Carbon Health Technologies Inc ( Site 2505)
North Hollywood, California, United States
UC Davis Medical Center ( Site 1833)
Sacramento, California, United States
Emerson Clinical Research Institute ( Site 1828)
Washington, District of Columbia, United States
JEM Research Institute ( Site 2508)
Atlantis, Florida, 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
Advanced Research For Health Improvement LLC ( Site 1816)
Immokalee, Florida, United States
Advanced Medical Research, LLC ( Site 1864)
Miami, Florida, United States
Advanced Research For Health Improvement LLC ( Site 1813)
Naples, Florida, United States
Bliss Healthcare Services ( Site 1847)
Orlando, Florida, United States
Javara Inc. ( Site 1869)
Albany, Georgia, United States
IACT Health ( Site 1818)
Columbus, Georgia, United States
Javara Inc. ( Site 1868)
Fayetteville, Georgia, United States
Loretto Hospital ( Site 1886)
Chicago, Illinois, United States
Jadestone Clinical Research, LLC ( Site 2502)
Laurel, Maryland, United States
Michigan Center of Medical Research ( Site 2500)
Farmington Hills, Michigan, United States
University of Nebraska Medical Center ( Site 2414)
Omaha, Nebraska, United States
Amici Clinical Research LLC ( Site 2507)
Raritan, New Jersey, United States
University of New Mexico, Health Sciences Center ( Site 1819)
Albuquerque, New Mexico, United States
AXCES Research Group ( Site 2418)
Santa Fe, New Mexico, United States
Saint Hope Foundation, Inc. ( Site 1830)
Bellaire, Texas, United States
The Crofoot Research Center, Inc. ( Site 1812)
Houston, Texas, United States
Javara Inc. ( Site 1866)
Sugar Land, Texas, United States
Clinical Research Partners, LLC. ( Site 2503)
Richmond, Virginia, United States
Swedish Medical Center First Hill ( Site 1807)
Seattle, Washington, United States
Fred Hutchinson Cancer Center ( Site 1829)
Seattle, Washington, United States
Multicare Health System ( Site 1811)
Spokane, Washington, United States
Multicare Health System ( Site 1814)
University Place, Washington, United States
Medical College Of Wisconsin ( Site 2510)
Milwaukee, Wisconsin, United States
Clinica Independencia ( Site 3400)
Vicente Lopez, Buenos Aires, Argentina
Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)
Rosario, Santa Fe, Argentina
Chronos Pesquisa Clínica ( Site 0155)
Brasilia, Distrito Federal, Brazil
Santa Casa de Misericordia de Belo Horizonte ( Site 0150)
Belo Horizonte, Minas Gerais, Brazil
Hospital de Clinicas da Universidade Federal do Parana ( Site 0154)
Curitiba, Parana, Brazil
Hospital Tacchini ( Site 0157)
Bento Goncalves, Rio Grande Do Sul, Brazil
FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151)
Sao Jose do Rio Preto, Sao Paulo, Brazil
Instituto de Infectologia Emilio Ribas ( Site 0153)
Sao Paulo, Brazil
Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152)
Sao Paulo, Brazil
Hamilton Medical Research Group ( Site 0207)
Hamilton, Ontario, Canada
University Health Network - Toronto General Hospital ( Site 0201)
Toronto, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0204)
Montreal, Quebec, Canada
Servicios Medicos Urumed ( Site 0307)
Rancagua, Lbtdr Gen Bernardo O Higgins, Chile
Clinical Research Chile SpA ( Site 0308)
Valdivia, Los Rios, Chile
Clinica Universidad de los Andes ( Site 0302)
Santiago, Region M. De Santiago, Chile
Fundacion Arturo Lopez Perez ( Site 0305)
Santiago, Region M. De Santiago, Chile
Espacio EME ( Site 0304)
Santiago, Region M. De Santiago, 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
Hospital Pablo Tobon Uribe ( Site 0405)
Medellin, Antioquia, Colombia
Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)
Barranquilla, Atlantico, Colombia
Clinica de la Costa Ltda. ( Site 0403)
Barranquilla, Atlantico, Colombia
Oncomedica S.A. ( Site 0407)
Monteria, Cordoba, 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
Fundacion Valle del Lili ( Site 0401)
Cali, Valle Del Cauca, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0415)
Cali, Valle Del Cauca, Colombia
National Center for allergies and chest ( Site 3320)
Giza, Al Jizah, Egypt
National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300)
Cairo, Al Qahirah, 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
Hopital Bichat Claude Bernard ( Site 0503)
Paris, Ain, France
Hopital Saint Joseph ( Site 0513)
Marseille, Bouches-du-Rhone, France
Groupe Hospitalier Pellegrin ( Site 0511)
Bordeaux, Gironde, 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, France
CHU Hopital Saint Antoine ( Site 0505)
Paris, France
Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)
Paris, France
Universitaetsklinikum Frankfurt ( Site 2302)
Frankfurt a main, Hessen, Germany
Universitaetsklinikum Essen ( Site 2305)
Essen, Nordrhein-Westfalen, Germany
ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301)
Berlin, Germany
ICH Study Center GmbH & Co.KG ( Site 2306)
Hamburg, Germany
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, Guatemala
Hadassah Medical Center. Ein Kerem ( Site 2100)
Jerusalem, Israel
Asl Napoli 1 Centro ( Site 0610)
Napoles, Napoli, Italy
Policlinico S. Orsola-Malpighi ( Site 0604)
Bologna, Italy
IRCCS Ospedale Policlinico San Martino ( Site 0603)
Genova, Italy
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606)
Milano, Italy
Ospedale San Raffaele ( Site 0605)
Milano, Italy
ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)
Milano, Italy
Ospedale Niguarda ( Site 0608)
Milano, 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, Italy
Chiba Aoba Municipal Hospital ( Site 0702)
Chiba, Japan
Den-en-chofu family clinic ( Site 0701)
Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine ( Site 0700)
Tokyo, Japan
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)
Ciudad de mexico, Distrito Federal, Mexico
CAIMED México ( Site 0814)
Mexico City, Distrito Federal, Mexico
Hospital Regional de Alta Especialidad del Bajio ( Site 0807)
Leon, Guanajuato, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)
Guadalajara, Jalisco, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)
Monterrey, Nuevo Leon, Mexico
Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0810)
Cancun, Quintana Roo, Mexico
Köhler & Milstein Research S.A. de C.V. ( Site 0809)
Merida, Yucatan, Mexico
ICARO Investigaciones en Medicina ( Site 0812)
Chihuahua, 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, Mexico
Lung Center of the Philippines ( Site 0902)
Quezon City, National Capital Region, Philippines
Quirino Memorial Medical Center ( Site 0903)
Quezon City, National Capital Region, Philippines
NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)
Lodz, Lodzkie, Poland
Krakowskie Centrum Medyczne Sp. z o.o ( Site 1008)
Krakow, Malopolskie, 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, Poland
Central Scientific Research Institute of Epidemiology ( Site 1104)
Moscow, Moskva, Russian Federation
Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1122)
Moscow, Moskva, Russian Federation
Hadassah Medical LTD ( Site 1124)
Moscow, Moskva, Russian Federation
Central Clinical Hospital with Polyclinic ( Site 1105)
Moscow, Moskva, Russian Federation
City Hospital No.33 of Leninsky ( Site 1127)
Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation
SPb SBHI City outpatient clinic 112 ( Site 1128)
Saint Petersburg, Sankt-Peterburg, 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 4 ( Site 1131)
Saint Petersburg, Sankt-Peterburg, Russian Federation
Strategic Medical System LLC ( Site 1114)
Saint-Petersburg, Sankt-Peterburg, Russian Federation
St.Petersburg Outpatient Clinic No. 109 ( Site 1119)
Saint-Petersburg, Sankt-Peterburg, Russian Federation
Limited liability company "Scientific research center Eco-safety" ( Site 1117)
Saint-Petersburg, Sankt-Peterburg, Russian Federation
City Polyclinic N44 ( Site 1130)
St.Petersburg, Sankt-Peterburg, Russian Federation
Smolensk State Medical University ( Site 1110)
Smolensk, Smolenskaya Oblast, Russian Federation
Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)
Kazan, Tatarstan, Respublika, Russian Federation
IATROS International ( Site 1212)
Bloemfontein, Free State, South Africa
Right To Care Research - Esizayo ( Site 1229)
Johannesburg, Gauteng, South Africa
Mzansi Ethical Research Centre ( Site 1225)
Mpumalanga, Gauteng, South Africa
Jongaie Research ( Site 1223)
Pretoria-West, Gauteng, South Africa
Wits Baragwanath Clinical Trial Site ( Site 1214)
Soweto, Gauteng, South Africa
Enhancing Care Foundation-DICRS ( Site 1216)
Durban, Kwazulu-Natal, South Africa
Limpopo Clinical Research Initiative ( Site 1227)
Thabazimbi, Limpopo, South Africa
TREAD Research ( Site 1211)
Cape Town, Western Cape, South Africa
Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219)
Cape Town, Western Cape, South Africa
Be Part Yoluntu Centre ( Site 1218)
Paarl, Western Cape, South Africa
Paarl Research Centre ( Site 1228)
Paarl, Western Cape, South Africa
Clinical Projects Research Centre ( Site 1215)
Worcester, Western Cape, South Africa
CAP Centelles ( Site 1308)
Centelles, Barcelona, Spain
Hospital General Universitario Gregorio Maranon ( Site 1302)
Madrid, Madrid, Comunidad De, 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
Hospital Universitario Infanta Leonor ( Site 1310)
Madrid, Spain
Hospital Universitario Ramon y Cajal ( Site 1301)
Madrid, Spain
Hospital Universitario La Paz ( Site 1300)
Madrid, Spain
Karolinska Universitetssjukhuset Solna ( Site 1400)
Stockholm, Stockholms Lan, Sweden
ClinSmart Sweden AB.Uppsala ( Site 1402)
Uppsala, Uppsala Lan, Sweden
Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)
Goteborg, Vastra Gotalands Lan, Sweden
National Taiwan University Hospital ( Site 3100)
Taipei, Taiwan
Taoyuan General Hospital ( Site 3101)
Taoyuan, Taiwan
Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)
Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)
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
Limited Liability Company Medical center Healthy Happy ( Site 1625)
Kyiv, Kyivska Oblast, Ukraine
LLC "Adonis plus" ( Site 1619)
Kyiv, Kyivska Oblast, Ukraine
Kyiv railway clinical hospital 2 of Branch Health center ( Site 1602)
Kyiv, Kyivska Oblast, Ukraine
ARTEM. State Holding Company ( Site 1618)
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, Ukraine
The Adam Practice ( Site 1708)
Poole, Dorset, United Kingdom
Accellacare South London Quality Research Centre ( Site 1709)
Orpington, Kent, United Kingdom
Royal Free London NHS Foundation Trust ( Site 1700)
London, London, City Of, United Kingdom
King's College Hospital ( Site 1707)
London, London, City Of, United Kingdom
Layton Medical Centre ( Site 1705)
Blackpool, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704)
Newcastle upon Tyne, United Kingdom
Medical Director, Study Director
Merck Sharp & Dohme LLC