Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002) | NCT04575597 | Trialant

Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002) | NCT04575597 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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 85381, United States

Ruane Clinical Research Group, Inc. ( Site 2406)

Los Angeles, California 90036, United States

Men's Health Foundation ( Site 1820)

Los Angeles, California 90069, United States

Carbon Health Technologies Inc ( Site 2505)

North Hollywood, California 91606, United States

UC Davis Medical Center ( Site 1833)

Sacramento, California 95817, United States

Emerson Clinical Research Institute ( Site 1828)

Washington D.C., District of Columbia 20011, United States

JEM Research Institute ( Site 2508)

Atlantis, Florida 33462, United States

Midway Immunology and Research Center ( Site 1837)

Ft. Pierce, Florida 34982, United States

Indago Research & Health Center, Inc ( Site 1809)

Hialeah, Florida 33012, United States

Advanced Research For Health Improvement LLC ( Site 1816)

Immokalee, Florida 34142, United States

Advanced Medical Research, LLC ( Site 1864)

Miami, Florida 33174, United States

Advanced Research For Health Improvement LLC ( Site 1813)

Naples, Florida 34102, United States

Bliss Healthcare Services ( Site 1847)

Orlando, Florida 32806, United States

Javara Inc. ( Site 1869)

Albany, Georgia 31707, United States

IACT Health ( Site 1818)

Columbus, Georgia 31904, United States

Javara Inc. ( Site 1868)

Fayetteville, Georgia 30214, United States

Loretto Hospital ( Site 1886)

Chicago, Illinois 60644, United States

Jadestone Clinical Research, LLC ( Site 2502)

Laurel, Maryland 20708, United States

Michigan Center of Medical Research ( Site 2500)

Farmington Hills, Michigan 48334, United States

University of Nebraska Medical Center ( Site 2414)

Omaha, Nebraska 68198, United States

Amici Clinical Research LLC ( Site 2507)

Raritan, New Jersey 08869, United States

University of New Mexico, Health Sciences Center ( Site 1819)

Albuquerque, New Mexico 87131, United States

AXCES Research Group ( Site 2418)

Santa Fe, New Mexico 87505, United States

Saint Hope Foundation, Inc. ( Site 1830)

Bellaire, Texas 77401, United States

The Crofoot Research Center, Inc. ( Site 1812)

Houston, Texas 77098, United States

Javara Inc. ( Site 1866)

Sugar Land, Texas 77478, United States

Clinical Research Partners, LLC. ( Site 2503)

Richmond, Virginia 23226, United States

Swedish Medical Center First Hill ( Site 1807)

Seattle, Washington 98104, United States

Fred Hutchinson Cancer Center ( Site 1829)

Seattle, Washington 98109, United States

Multicare Health System ( Site 1811)

Spokane, Washington 99204, United States

Multicare Health System ( Site 1814)

University Place, Washington 98466, United States

Medical College Of Wisconsin ( Site 2510)

Milwaukee, Wisconsin 53226, United States

Clinica Independencia ( Site 3400)

Vicente López, Buenos Aires B1605FRE, Argentina

Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)

Rosario, Santa Fe Province 2000, Argentina

Chronos Pesquisa Clínica ( Site 0155)

Brasília, Federal District 72145-424, Brazil

Santa Casa de Misericordia de Belo Horizonte ( Site 0150)

Belo Horizonte, Minas Gerais 30150-221, Brazil

Hospital de Clinicas da Universidade Federal do Parana ( Site 0154)

Curitiba, Paraná 80060-900, Brazil

Hospital Tacchini ( Site 0157)

Bento Gonçalves, Rio Grande do Sul 95700-000, Brazil

FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151)

São José do Rio Preto, São Paulo 15090-000, Brazil

Instituto de Infectologia Emilio Ribas ( Site 0153)

São Paulo, 01246-900, Brazil

Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152)

São Paulo, 05403-010, Brazil

Hamilton Medical Research Group ( Site 0207)

Hamilton, Ontario L8M1K7, Canada

University Health Network - Toronto General Hospital ( Site 0201)

Toronto, Ontario M5G 2N2, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)

Montreal, Quebec H2X 3E4, Canada

McGill University Health Centre ( Site 0204)

Montreal, Quebec H4A 3J1, Canada

Servicios Medicos Urumed ( Site 0307)

Rancagua, Lbtdr Gen Bernardo O Higgins 2852424, Chile

Clinical Research Chile SpA ( Site 0308)

Valdivia, Los Ríos Region 5110683, Chile

Clinica Universidad de los Andes ( Site 0302)

Santiago, Region M. de Santiago 2820945, Chile

Fundacion Arturo Lopez Perez ( Site 0305)

Santiago, Region M. de Santiago 7500921, Chile

Espacio EME ( Site 0304)

Santiago, Region M. de Santiago 7770086, Chile

Centro de Investigacion Clinica UC CICUC ( Site 0309)

Santiago, Region M. de Santiago 8330034, Chile

Clinica Bicentenario Spa ( Site 0306)

Santiago, Region M. de Santiago 9160000, Chile

Hospital Pablo Tobon Uribe ( Site 0405)

Medellín, Antioquia 050034, Colombia

Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)

Barranquilla, Atlántico 080020, Colombia

Clinica de la Costa Ltda. ( Site 0403)

Barranquilla, Atlántico 080020, Colombia

Fundacion Santa Fe de Bogota ( Site 0412)

Bogotá, Bogota D.C. 110111, Colombia

Caja de Compensación Familiar CAFAM. Sede Centro de Atención en Salud CAFAM Floresta ( Site 0406)

Bogota, Cundinamarca 111211, Colombia

Centro de Atencion e Investigacion Medica CAIMED ( Site 0413)

Bogota, Cundinamarca 111611, Colombia

Oncomedica S.A. ( Site 0407)

Montería, Departamento de Córdoba 230002, Colombia

Fundacion Cardiovascular de Colombia ( Site 0402)

Bucaramanca, Santander Department 680003, Colombia

Fundacion Valle del Lili ( Site 0401)

Cali, Valle del Cauca Department 760032, Colombia

Centro Medico Imbanaco de Cali S.A ( Site 0415)

Cali, Valle del Cauca Department 760042, Colombia

National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300)

Cairo, Cairo Governorate 11562, Egypt

Abbassia Chest Hospital ( Site 3340)

Cairo, Cairo Governorate 11591, Egypt

Abbassia Fever Hospital ( Site 3330)

Cairo, Cairo Governorate 11591, Egypt

Helwan Fever Hospital ( Site 3350)

Cairo, Cairo Governorate 12899, Egypt

National Center for allergies and chest ( Site 3320)

Giza, Giza Governorate 12651, Egypt

Hopital Bichat Claude Bernard ( Site 0503)

Paris, Ain 75018, France

Hopital Saint Joseph ( Site 0513)

Marseille, Bouches-du-Rhone 13285, France

Groupe Hospitalier Pellegrin ( Site 0511)

Bordeaux, Gironde 33000, France

CHU de la Reunion - Groupe Hospitalier Sud ( Site 0514)

Saint-Pierre, La Reunion 97448, France

C.H.U. de Toulouse Hopital Purpan ( Site 0501)

Toulouse, Midi-Pyrenees 31059, France

Centre Hospitalier de Tourcoing ( Site 0502)

Tourcoing, Nord 59208, France

CHU Hopital Saint Antoine ( Site 0505)

Paris, 75012, France

Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)

Paris, 75013, France

Universitaetsklinikum Frankfurt ( Site 2302)

Frankfurt A Main, Hesse 60590, Germany

Universitaetsklinikum Essen ( Site 2305)

Essen, North Rhine-Westphalia 45147, Germany

ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301)

Berlin, 10439, Germany

ICH Study Center GmbH & Co.KG ( Site 2306)

Hamburg, 20146, Germany

Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 2601)

Guatemala City, 01009, Guatemala

Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2600)

Guatemala City, 01015, Guatemala

Hadassah Medical Center. Ein Kerem ( Site 2100)

Jerusalem, 9112001, Israel

Asl Napoli 1 Centro ( Site 0610)

Naples, Napoli 80145, Italy

Policlinico S. Orsola-Malpighi ( Site 0604)

Bologna, 40138, Italy

IRCCS Ospedale Policlinico San Martino ( Site 0603)

Genova, 16132, Italy

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606)

Milan, 20122, Italy

Ospedale San Raffaele ( Site 0605)

Milan, 20127, Italy

ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

Milan, 20157, Italy

Ospedale Niguarda ( Site 0608)

Milan, 20162, Italy

AOU Policlinico Paolo Giaccone ( Site 0609)

Palermo, 90127, Italy

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 0600)

Roma, 00149, Italy

Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602)

Torino, 10149, Italy

Azienda Sanitaria Universitaria Friuli Centrale -ASU FC ( Site 0607)

Udine, 33100, Italy

Chiba Aoba Municipal Hospital ( Site 0702)

Chiba, 260-0852, Japan

Den-en-chofu family clinic ( Site 0701)

Tokyo, 145-0071, Japan

Center Hospital of the National Center for Global Health and Medicine ( Site 0700)

Tokyo, 162-8655, Japan

Hospital Regional de Alta Especialidad del Bajio ( Site 0807)

León, Guanajuato 37660, Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

Guadalajara, Jalisco 44280, Mexico

CAIMED México ( Site 0814)

Mexico City, Mexico City 06760, Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)

Mexico City, Mexico City 14080, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)

Monterrey, Nuevo León 64460, Mexico

Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0810)

Cancún, Quintana Roo 70500, Mexico

Köhler & Milstein Research S.A. de C.V. ( Site 0809)

Mérida, Yucatán 97070, Mexico

ICARO Investigaciones en Medicina ( Site 0812)

Chihuahua City, 31000, Mexico

Oaxaca Site Management Organization S.C. ( Site 0811)

Oaxaca City, 68000, Mexico

Clinical Research Institute S.C. ( Site 0813)

Tlalnepantla, 54055, Mexico

Arké SMO S.A de C.V ( Site 0808)

Veracruz, 91910, Mexico

Lung Center of the Philippines ( Site 0902)

Quezon City, National Capital Region 1100, Philippines

Quirino Memorial Medical Center ( Site 0903)

Quezon City, National Capital Region 1109, Philippines

Krakowskie Centrum Medyczne Sp. z o.o ( Site 1008)

Krakow, Lesser Poland Voivodeship 31-501, Poland

Centrum Medyczne Pulawska Sp. z o.o. ( Site 1007)

Piaseczno, Masovian Voivodeship 05-500, Poland

Centrum Medyczne MEDYK Sp. z o.o. Sp.k. ( Site 1009)

Rzeszów, Podkarpackie Voivodeship 35-326, Poland

NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)

Lodz, Łódź Voivodeship 90-302, Poland

Central Scientific Research Institute of Epidemiology ( Site 1104)

Moscow, Moscow 111123, Russia

Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1122)

Moscow, Moscow 115419, Russia

Hadassah Medical LTD ( Site 1124)

Moscow, Moscow 121205, Russia

Central Clinical Hospital with Polyclinic ( Site 1105)

Moscow, Moscow 121359, Russia

City Hospital No.33 of Leninsky ( Site 1127)

Nizhny Novgorod, Nizhny Novgorod Oblast 603076, Russia

City Polyclinic N44 ( Site 1130)

Saint Petersburg, Sankt-Peterburg 192071, Russia

Strategic Medical System LLC ( Site 1114)

Saint Petersburg, Sankt-Peterburg 192148, Russia

St.Petersburg Outpatient Clinic No. 109 ( Site 1119)

Saint Petersburg, Sankt-Peterburg 192289, Russia

SPb SBHI City outpatient clinic 112 ( Site 1128)

Saint Petersburg, Sankt-Peterburg 195427, Russia

Medical Research Institute LLC ( Site 1116)

Saint Petersburg, Sankt-Peterburg 196084, Russia

Limited liability company "Scientific research center Eco-safety" ( Site 1117)

Saint Petersburg, Sankt-Peterburg 196143, Russia

Smorodintsev Research Institute of Influenza ( Site 1129)

Saint Petersburg, Sankt-Peterburg 197376, Russia

SPb SBHI City outpatient clinic 4 ( Site 1131)

Saint Petersburg, Sankt-Peterburg 199406, Russia

Smolensk State Medical University ( Site 1110)

Smolensk, Smolensk Oblast 214019, Russia

Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)

Kazan', Tatarstan, Respublika 420140, Russia

IATROS International ( Site 1212)

Bloemfontein, Free State 9300, South Africa

Right To Care Research - Esizayo ( Site 1229)

Johannesburg, Gauteng 2087, South Africa

Mzansi Ethical Research Centre ( Site 1225)

Mpumalanga, Gauteng 1055, South Africa

Jongaie Research ( Site 1223)

Pretoria West, Gauteng 0183, South Africa

Wits Baragwanath Clinical Trial Site ( Site 1214)

Soweto, Gauteng 2013, South Africa

Enhancing Care Foundation-DICRS ( Site 1216)

Durban, KwaZulu-Natal 4091, South Africa

Limpopo Clinical Research Initiative ( Site 1227)

Thabazimbi, Limpopo 0380, South Africa

TREAD Research ( Site 1211)

Cape Town, Western Cape 7500, South Africa

Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219)

Cape Town, Western Cape 7925, South Africa

Be Part Yoluntu Centre ( Site 1218)

Paarl, Western Cape 7626, South Africa

Paarl Research Centre ( Site 1228)

Paarl, Western Cape 7646, South Africa

Clinical Projects Research Centre ( Site 1215)

Worcester, Western Cape 6850, South Africa

CAP Centelles ( Site 1308)

Centelles, Barcelona 08540, Spain

Fundacion Hospital Alcorcon de Madrid ( Site 1314)

Alcorcón, Madrid 28922, Spain

Hospital General Universitario Gregorio Maranon ( Site 1302)

Madrid, Madrid, Comunidad de 28007, Spain

CAP Sardenya - Barcelona ( Site 1307)

Barcelona, 08025, Spain

Hospital Clinic ( Site 1304)

Barcelona, 08036, Spain

Hospital Universitari Germans Trias i Pujol ( Site 1303)

Barcelona, 08916, Spain

Hospital Universitario Infanta Leonor ( Site 1310)

Madrid, 28031, Spain

Hospital Universitario Ramon y Cajal ( Site 1301)

Madrid, 28034, Spain

Hospital Universitario La Paz ( Site 1300)

Madrid, 28046, Spain

Karolinska Universitetssjukhuset Solna ( Site 1400)

Stockholm, Stockholm County 113 61, Sweden

ClinSmart Sweden AB.Uppsala ( Site 1402)

Uppsala, Uppsala County 752 37, Sweden

Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)

Gothenburg, Västra Götaland County 416 85, Sweden

National Taiwan University Hospital ( Site 3100)

Taipei, 100, Taiwan

Taoyuan General Hospital ( Site 3101)

Taoyuan, 33004, Taiwan

Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)

Ivano-Frankivsk, Ivano-Frankivsk Oblast 76007, Ukraine

CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)

Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine

MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)

Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine

Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 1621)

Kharkiv, Kharkiv Oblast 61002, Ukraine

PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 1627)

Kharkiv, Kharkiv Oblast 61172, Ukraine

Limited Liability Company Medical center Healthy Happy ( Site 1625)

Kyiv, Kyivska Oblast 01033, Ukraine

LLC "Adonis plus" ( Site 1619)

Kyiv, Kyivska Oblast 02002, Ukraine

Kyiv railway clinical hospital 2 of Branch Health center ( Site 1602)

Kyiv, Kyivska Oblast 03049, Ukraine

ARTEM. State Holding Company ( Site 1618)

Kyiv, Kyivska Oblast 04050, Ukraine

Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 1622)

Lviv, Lviv Oblast 79011, Ukraine

MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 1626)

Odesa, Odesa Oblast 65025, Ukraine

Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614)

Poltava, Poltava Oblast 36011, Ukraine

Medical Center Health Clinic ( Site 1623)

Vinnytsia, Vinnytsia Oblast 21009, Ukraine

The Adam Practice ( Site 1708)

Poole, Dorset BH15 2HX, United Kingdom

Accellacare South London Quality Research Centre ( Site 1709)

Orpington, Kent BR5 3QG, United Kingdom

Royal Free London NHS Foundation Trust ( Site 1700)

London, London, City of NW3 2QG, United Kingdom

King's College Hospital ( Site 1707)

London, London, City of SE5 9RS, United Kingdom

Layton Medical Centre ( Site 1705)

Blackpool, FY3 7EN, United Kingdom

Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704)

Newcastle upon Tyne, NE1 4LP, United Kingdom