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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

1,735

Participants

Timeline

Start Date

October 19, 2020

Primary Completion Date

May 5, 2022

Study Completion Date

May 5, 2022

Conditions
Coronavirus Disease (COVID-19)
Interventions
DRUG

Molnupiravir

Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)

DRUG

Placebo

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

Trial Locations (173)

100

National Taiwan University Hospital ( Site 3100), Taipei

1055

Mzansi Ethical Research Centre ( Site 1225), Mpumalanga

1100

Lung Center of the Philippines ( Site 0902), Quezon City

1109

Quirino Memorial Medical Center ( Site 0903), Quezon City

2000

Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401), Rosario

2013

Wits Baragwanath Clinical Trial Site ( Site 1214), Soweto

2087

Right To Care Research - Esizayo ( Site 1229), Johannesburg

4091

Enhancing Care Foundation-DICRS ( Site 1216), Durban

6850

Clinical Projects Research Centre ( Site 1215), Worcester

7500

TREAD Research ( Site 1211), Cape Town

7626

Be Part Yoluntu Centre ( Site 1218), Paarl

7646

Paarl Research Centre ( Site 1228), Paarl

7925

Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219), Cape Town

9300

IATROS International ( Site 1212), Bloemfontein

10149

Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602), Torino

10439

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

11562

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

11591

Abbassia Chest Hospital ( Site 3340), Cairo

Abbassia Fever Hospital ( Site 3330), Cairo

12651

National Center for allergies and chest ( Site 3320), Giza

12899

Helwan Fever Hospital ( Site 3350), Cairo

13285

Hopital Saint Joseph ( Site 0513), Marseille

14080

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

16132

IRCCS Ospedale Policlinico San Martino ( Site 0603), Genova

20011

Emerson Clinical Research Institute ( Site 1828), Washington D.C.

20122

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

20127

Ospedale San Raffaele ( Site 0605), Milan

20146

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

20157

ASST Fatebenefratelli-Ospedale Sacco ( Site 0601), Milan

20162

Ospedale Niguarda ( Site 0608), Milan

20708

Jadestone Clinical Research, LLC ( Site 2502), Laurel

21009

Medical Center Health Clinic ( Site 1623), Vinnytsia

23226

Clinical Research Partners, LLC. ( Site 2503), Richmond

28007

Hospital General Universitario Gregorio Maranon ( Site 1302), Madrid

28031

Hospital Universitario Infanta Leonor ( Site 1310), Madrid

28034

Hospital Universitario Ramon y Cajal ( Site 1301), Madrid

28046

Hospital Universitario La Paz ( Site 1300), Madrid

28922

Fundacion Hospital Alcorcon de Madrid ( Site 1314), Alcorcón

30214

Javara Inc. ( Site 1868), Fayetteville

31000

ICARO Investigaciones en Medicina ( Site 0812), Chihuahua City

31059

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

31707

Javara Inc. ( Site 1869), Albany

31904

IACT Health ( Site 1818), Columbus

32806

Bliss Healthcare Services ( Site 1847), Orlando

33000

Groupe Hospitalier Pellegrin ( Site 0511), Bordeaux

33004

Taoyuan General Hospital ( Site 3101), Taoyuan District

33012

Indago Research & Health Center, Inc ( Site 1809), Hialeah

33100

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

33174

Advanced Medical Research, LLC ( Site 1864), Miami

33462

JEM Research Institute ( Site 2508), Atlantis

34102

Advanced Research For Health Improvement LLC ( Site 1813), Naples

34142

Advanced Research For Health Improvement LLC ( Site 1816), Immokalee

34982

Midway Immunology and Research Center ( Site 1837), Ft. Pierce

36011

Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614), Poltava

37660

Hospital Regional de Alta Especialidad del Bajio ( Site 0807), León

40138

Policlinico S. Orsola-Malpighi ( Site 0604), Bologna

44280

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800), Guadalajara

45147

Universitaetsklinikum Essen ( Site 2305), Essen

48334

Michigan Center of Medical Research ( Site 2500), Farmington Hills

53226

Medical College Of Wisconsin ( Site 2510), Milwaukee

54055

Clinical Research Institute S.C. ( Site 0813), Tlalnepantla

59208

Centre Hospitalier de Tourcoing ( Site 0502), Tourcoing

60590

Universitaetsklinikum Frankfurt ( Site 2302), Frankfurt A Main

60644

Loretto Hospital ( Site 1886), Chicago

61002

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

61172

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

64460

Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803), Monterrey

65025

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

68000

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

68198

University of Nebraska Medical Center ( Site 2414), Omaha

70500

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

75012

CHU Hopital Saint Antoine ( Site 0505), Paris

75013

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

75018

Hopital Bichat Claude Bernard ( Site 0503), Paris

76007

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

76018

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

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

77098

The Crofoot Research Center, Inc. ( Site 1812), Houston

77401

Saint Hope Foundation, Inc. ( Site 1830), Bellaire

77478

Javara Inc. ( Site 1866), Sugar Land

79011

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

80145

Asl Napoli 1 Centro ( Site 0610), Naples

85381

Phoenix Medical Group ( Site 1822), Peoria

87131

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

87505

AXCES Research Group ( Site 2418), Santa Fe

90036

Ruane Clinical Research Group, Inc. ( Site 2406), Los Angeles

90069

Men's Health Foundation ( Site 1820), Los Angeles

90127

AOU Policlinico Paolo Giaccone ( Site 0609), Palermo

91606

Carbon Health Technologies Inc ( Site 2505), North Hollywood

91910

Arké SMO S.A de C.V ( Site 0808), Veracruz

95817

UC Davis Medical Center ( Site 1833), Sacramento

97070

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

97448

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

98104

Swedish Medical Center First Hill ( Site 1807), Seattle

98109

Fred Hutchinson Cancer Center ( Site 1829), Seattle

98466

Multicare Health System ( Site 1814), University Place

99204

Multicare Health System ( Site 1811), Spokane

110111

Fundacion Santa Fe de Bogota ( Site 0412), Bogotá

111123

Central Scientific Research Institute of Epidemiology ( Site 1104), Moscow

111211

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

111611

Centro de Atencion e Investigacion Medica CAIMED ( Site 0413), Bogota

115419

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

121205

Hadassah Medical LTD ( Site 1124), Moscow

121359

Central Clinical Hospital with Polyclinic ( Site 1105), Moscow

192071

City Polyclinic N44 ( Site 1130), Saint Petersburg

192148

Strategic Medical System LLC ( Site 1114), Saint Petersburg

192289

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

195427

SPb SBHI City outpatient clinic 112 ( Site 1128), Saint Petersburg

196084

Medical Research Institute LLC ( Site 1116), Saint Petersburg

196143

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

197376

Smorodintsev Research Institute of Influenza ( Site 1129), Saint Petersburg

199406

SPb SBHI City outpatient clinic 4 ( Site 1131), Saint Petersburg

214019

Smolensk State Medical University ( Site 1110), Smolensk

230002

Oncomedica S.A. ( Site 0407), Montería

420140

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

603076

City Hospital No.33 of Leninsky ( Site 1127), Nizhny Novgorod

680003

Fundacion Cardiovascular de Colombia ( Site 0402), Bucaramanca

760032

Fundacion Valle del Lili ( Site 0401), Santiago de Cali

760042

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

2820945

Clinica Universidad de los Andes ( Site 0302), Santiago

2852424

Servicios Medicos Urumed ( Site 0307), Rancagua

5110683

Clinical Research Chile SpA ( Site 0308), Valdivia

7500921

Fundacion Arturo Lopez Perez ( Site 0305), Santiago

7770086

Espacio EME ( Site 0304), Santiago

8330034

Centro de Investigacion Clinica UC CICUC ( Site 0309), Santiago

9112001

Hadassah Medical Center. Ein Kerem ( Site 2100), Jerusalem

9160000

Clinica Bicentenario Spa ( Site 0306), Santiago

08869

Amici Clinical Research LLC ( Site 2507), Raritan

B1605FRE

Clinica Independencia ( Site 3400), Vicente López

72145-424

Chronos Pesquisa Clínica ( Site 0155), Brasília

30150-221

Santa Casa de Misericordia de Belo Horizonte ( Site 0150), Belo Horizonte

80060-900

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

95700-000

Hospital Tacchini ( Site 0157), Bento Gonçalves

15090-000

FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151), São José do Rio Preto

01246-900

Instituto de Infectologia Emilio Ribas ( Site 0153), São Paulo

05403-010

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

L8M1K7

Hamilton Medical Research Group ( Site 0207), Hamilton

M5G 2N2

University Health Network - Toronto General Hospital ( Site 0201), Toronto

H2X 3E4

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

H4A 3J1

McGill University Health Centre ( Site 0204), Montreal

050034

Hospital Pablo Tobon Uribe ( Site 0405), Medellín

080020

Centro Cientifico Asistencial Jose Luis Accini ( Site 0416), Barranquilla

Clinica de la Costa Ltda. ( Site 0403), Barranquilla

01009

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

01015

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

00149

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

260-0852

Chiba Aoba Municipal Hospital ( Site 0702), Chiba

145-0071

Den-en-chofu family clinic ( Site 0701), Tokyo

162-8655

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

06760

CAIMED México ( Site 0814), Mexico City

31-501

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

05-500

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

35-326

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

90-302

NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006), Lodz

0183

Jongaie Research ( Site 1223), Pretoria West

0380

Limpopo Clinical Research Initiative ( Site 1227), Thabazimbi

08540

CAP Centelles ( Site 1308), Centelles

08025

CAP Sardenya - Barcelona ( Site 1307), Barcelona

08036

Hospital Clinic ( Site 1304), Barcelona

08916

Hospital Universitari Germans Trias i Pujol ( Site 1303), Barcelona

113 61

Karolinska Universitetssjukhuset Solna ( Site 1400), Stockholm

752 37

ClinSmart Sweden AB.Uppsala ( Site 1402), Uppsala

416 85

Sahlgrenska Universitetssjukhuset Ostra ( Site 1401), Gothenburg

01033

Limited Liability Company Medical center Healthy Happy ( Site 1625), Kyiv

02002

"LLC Adonis plus ( Site 1619)", Kyiv

03049

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

04050

ARTEM. State Holding Company ( Site 1618), Kyiv

BH15 2HX

The Adam Practice ( Site 1708), Poole

BR5 3QG

Accellacare South London Quality Research Centre ( Site 1709), Orpington

NW3 2QG

Royal Free London NHS Foundation Trust ( Site 1700), London

SE5 9RS

King's College Hospital ( Site 1707), London

FY3 7EN

Layton Medical Centre ( Site 1705), Blackpool

NE1 4LP

Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704), Newcastle upon Tyne

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

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