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

NCT04575597 | Completed Phase 2 Results DMC FDA Drug

• 5 other identifiers: 4482-002MK-4482-002PHRR201209-003186jRCT20312101482020-003368-24
• Study Type: interventional
• Target: 1,735
• Locations: 23 countries
• Sites: 173

Brief 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

Conditions

Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (35)

• Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough

  Up to 29 days

• Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat

  Up to 29 days

• Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion

  Up to 29 days

• Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea

  Up to 29 days

• Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing

  Up to 29 days

Study Arms (6)

Part 1: Molnupiravir 200 mg

EXPERIMENTAL

200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Drug: Molnupiravir

Part 1: Molnupiravir 400 mg

EXPERIMENTAL

400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Drug: Molnupiravir

Part 1: Molnupiravir 800 mg

EXPERIMENTAL

800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)

Drug: Molnupiravir

Part 1: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part 2: Molnupiravir 800 mg

EXPERIMENTAL

800 mg Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)

Drug: Molnupiravir

Part 2: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Molnupiravir DRUG

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

Also known as: MK-4482

Part 1: Molnupiravir 200 mg; Part 1: Molnupiravir 400 mg; Part 1: Molnupiravir 800 mg; Part 2: Molnupiravir 800 mg

Placebo DRUG

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

Part 1: Placebo; Part 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (173)

Phoenix Medical Group ( Site 1822)

Peoria, Arizona, 85381, United States

Location

Ruane Clinical Research Group, Inc. ( Site 2406)

Los Angeles, California, 90036, United States

Location

Men's Health Foundation ( Site 1820)

Los Angeles, California, 90069, United States

Location

Carbon Health Technologies Inc ( Site 2505)

North Hollywood, California, 91606, United States

Location

UC Davis Medical Center ( Site 1833)

Sacramento, California, 95817, United States

Location

Emerson Clinical Research Institute ( Site 1828)

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

Location

JEM Research Institute ( Site 2508)

Atlantis, Florida, 33462, United States

Location

Midway Immunology and Research Center ( Site 1837)

Ft. Pierce, Florida, 34982, United States

Location

Indago Research & Health Center, Inc ( Site 1809)

Hialeah, Florida, 33012, United States

Location

Advanced Research For Health Improvement LLC ( Site 1816)

Immokalee, Florida, 34142, United States

Location

Advanced Medical Research, LLC ( Site 1864)

Miami, Florida, 33174, United States

Location

Advanced Research For Health Improvement LLC ( Site 1813)

Naples, Florida, 34102, United States

Location

Bliss Healthcare Services ( Site 1847)

Orlando, Florida, 32806, United States

Location

Javara Inc. ( Site 1869)

Albany, Georgia, 31707, United States

Location

IACT Health ( Site 1818)

Columbus, Georgia, 31904, United States

Location

Javara Inc. ( Site 1868)

Fayetteville, Georgia, 30214, United States

Location

Loretto Hospital ( Site 1886)

Chicago, Illinois, 60644, United States

Location

Jadestone Clinical Research, LLC ( Site 2502)

Laurel, Maryland, 20708, United States

Location

Michigan Center of Medical Research ( Site 2500)

Farmington Hills, Michigan, 48334, United States

Location

University of Nebraska Medical Center ( Site 2414)

Omaha, Nebraska, 68198, United States

Location

Amici Clinical Research LLC ( Site 2507)

Raritan, New Jersey, 08869, United States

Location

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

Albuquerque, New Mexico, 87131, United States

Location

AXCES Research Group ( Site 2418)

Santa Fe, New Mexico, 87505, United States

Location

Saint Hope Foundation, Inc. ( Site 1830)

Bellaire, Texas, 77401, United States

Location

The Crofoot Research Center, Inc. ( Site 1812)

Houston, Texas, 77098, United States

Location

Javara Inc. ( Site 1866)

Sugar Land, Texas, 77478, United States

Location

Clinical Research Partners, LLC. ( Site 2503)

Richmond, Virginia, 23226, United States

Location

Swedish Medical Center First Hill ( Site 1807)

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Center ( Site 1829)

Seattle, Washington, 98109, United States

Location

Multicare Health System ( Site 1811)

Spokane, Washington, 99204, United States

Location

Multicare Health System ( Site 1814)

University Place, Washington, 98466, United States

Location

Medical College Of Wisconsin ( Site 2510)

Milwaukee, Wisconsin, 53226, United States

Location

Clinica Independencia ( Site 3400)

Vicente López, Buenos Aires, B1605FRE, Argentina

Location

Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)

Rosario, Santa Fe Province, 2000, Argentina

Location

Chronos Pesquisa Clínica ( Site 0155)

Brasília, Federal District, 72145-424, Brazil

Location

Santa Casa de Misericordia de Belo Horizonte ( Site 0150)

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

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

Curitiba, Paraná, 80060-900, Brazil

Location

Hospital Tacchini ( Site 0157)

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

Location

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

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

Location

Instituto de Infectologia Emilio Ribas ( Site 0153)

São Paulo, 01246-900, Brazil

Location

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

São Paulo, 05403-010, Brazil

Location

Hamilton Medical Research Group ( Site 0207)

Hamilton, Ontario, L8M1K7, Canada

Location

University Health Network - Toronto General Hospital ( Site 0201)

Toronto, Ontario, M5G 2N2, Canada

Location

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

Montreal, Quebec, H2X 3E4, Canada

Location

McGill University Health Centre ( Site 0204)

Montreal, Quebec, H4A 3J1, Canada

Location

Servicios Medicos Urumed ( Site 0307)

Rancagua, Lbtdr Gen Bernardo O Higgins, 2852424, Chile

Location

Clinical Research Chile SpA ( Site 0308)

Valdivia, Los Ríos Region, 5110683, Chile

Location

Clinica Universidad de los Andes ( Site 0302)

Santiago, Region M. de Santiago, 2820945, Chile

Location

Fundacion Arturo Lopez Perez ( Site 0305)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Espacio EME ( Site 0304)

Santiago, Region M. de Santiago, 7770086, Chile

Location

Centro de Investigacion Clinica UC CICUC ( Site 0309)

Santiago, Region M. de Santiago, 8330034, Chile

Location

Clinica Bicentenario Spa ( Site 0306)

Santiago, Region M. de Santiago, 9160000, Chile

Location

Hospital Pablo Tobon Uribe ( Site 0405)

Medellín, Antioquia, 050034, Colombia

Location

Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)

Barranquilla, Atlántico, 080020, Colombia

Location

Clinica de la Costa Ltda. ( Site 0403)

Barranquilla, Atlántico, 080020, Colombia

Location

Fundacion Santa Fe de Bogota ( Site 0412)

Bogotá, Bogota D.C., 110111, Colombia

Location

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

Bogota, Cundinamarca, 111211, Colombia

Location

Centro de Atencion e Investigacion Medica CAIMED ( Site 0413)

Bogota, Cundinamarca, 111611, Colombia

Location

Oncomedica S.A. ( Site 0407)

Montería, Departamento de Córdoba, 230002, Colombia

Location

Fundacion Cardiovascular de Colombia ( Site 0402)

Bucaramanca, Santander Department, 680003, Colombia

Location

Fundacion Valle del Lili ( Site 0401)

Cali, Valle del Cauca Department, 760032, Colombia

Location

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

Cali, Valle del Cauca Department, 760042, Colombia

Location

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

Cairo, Cairo Governorate, 11562, Egypt

Location

Abbassia Chest Hospital ( Site 3340)

Cairo, Cairo Governorate, 11591, Egypt

Location

Abbassia Fever Hospital ( Site 3330)

Cairo, Cairo Governorate, 11591, Egypt

Location

Helwan Fever Hospital ( Site 3350)

Cairo, Cairo Governorate, 12899, Egypt

Location

National Center for allergies and chest ( Site 3320)

Giza, Giza Governorate, 12651, Egypt

Location

Hopital Bichat Claude Bernard ( Site 0503)

Paris, Ain, 75018, France

Location

Hopital Saint Joseph ( Site 0513)

Marseille, Bouches-du-Rhone, 13285, France

Location

Groupe Hospitalier Pellegrin ( Site 0511)

Bordeaux, Gironde, 33000, France

Location

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

Saint-Pierre, La Reunion, 97448, France

Location

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

Toulouse, Midi-Pyrenees, 31059, France

Location

Centre Hospitalier de Tourcoing ( Site 0502)

Tourcoing, Nord, 59208, France

Location

CHU Hopital Saint Antoine ( Site 0505)

Paris, 75012, France

Location

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

Paris, 75013, France

Location

Universitaetsklinikum Frankfurt ( Site 2302)

Frankfurt A Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Essen ( Site 2305)

Essen, North Rhine-Westphalia, 45147, Germany

Location

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

Berlin, 10439, Germany

Location

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

Hamburg, 20146, Germany

Location

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

Guatemala City, 01009, Guatemala

Location

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

Guatemala City, 01015, Guatemala

Location

Hadassah Medical Center. Ein Kerem ( Site 2100)

Jerusalem, 9112001, Israel

Location

Asl Napoli 1 Centro ( Site 0610)

Naples, Napoli, 80145, Italy

Location

Policlinico S. Orsola-Malpighi ( Site 0604)

Bologna, 40138, Italy

Location

IRCCS Ospedale Policlinico San Martino ( Site 0603)

Genova, 16132, Italy

Location

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

Milan, 20122, Italy

Location

Ospedale San Raffaele ( Site 0605)

Milan, 20127, Italy

Location

ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

Milan, 20157, Italy

Location

Ospedale Niguarda ( Site 0608)

Milan, 20162, Italy

Location

AOU Policlinico Paolo Giaccone ( Site 0609)

Palermo, 90127, Italy

Location

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

Roma, 00149, Italy

Location

Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602)

Torino, 10149, Italy

Location

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

Udine, 33100, Italy

Location

Chiba Aoba Municipal Hospital ( Site 0702)

Chiba, 260-0852, Japan

Location

Den-en-chofu family clinic ( Site 0701)

Tokyo, 145-0071, Japan

Location

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

Tokyo, 162-8655, Japan

Location

Hospital Regional de Alta Especialidad del Bajio ( Site 0807)

León, Guanajuato, 37660, Mexico

Location

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

Guadalajara, Jalisco, 44280, Mexico

Location

CAIMED México ( Site 0814)

Mexico City, Mexico City, 06760, Mexico

Location

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

Mexico City, Mexico City, 14080, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)

Monterrey, Nuevo León, 64460, Mexico

Location

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

Cancún, Quintana Roo, 70500, Mexico

Location

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

Mérida, Yucatán, 97070, Mexico

Location

ICARO Investigaciones en Medicina ( Site 0812)

Chihuahua City, 31000, Mexico

Location

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

Oaxaca City, 68000, Mexico

Location

Clinical Research Institute S.C. ( Site 0813)

Tlalnepantla, 54055, Mexico

Location

Arké SMO S.A de C.V ( Site 0808)

Veracruz, 91910, Mexico

Location

Lung Center of the Philippines ( Site 0902)

Quezon City, National Capital Region, 1100, Philippines

Location

Quirino Memorial Medical Center ( Site 0903)

Quezon City, National Capital Region, 1109, Philippines

Location

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

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

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

Piaseczno, Masovian Voivodeship, 05-500, Poland

Location

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

Rzeszów, Podkarpackie Voivodeship, 35-326, Poland

Location

NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)

Lodz, Łódź Voivodeship, 90-302, Poland

Location

Central Scientific Research Institute of Epidemiology ( Site 1104)

Moscow, Moscow, 111123, Russia

Location

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

Moscow, Moscow, 115419, Russia

Location

Hadassah Medical LTD ( Site 1124)

Moscow, Moscow, 121205, Russia

Location

Central Clinical Hospital with Polyclinic ( Site 1105)

Moscow, Moscow, 121359, Russia

Location

City Hospital No.33 of Leninsky ( Site 1127)

Nizhny Novgorod, Nizhny Novgorod Oblast, 603076, Russia

Location

City Polyclinic N44 ( Site 1130)

Saint Petersburg, Sankt-Peterburg, 192071, Russia

Location

Strategic Medical System LLC ( Site 1114)

Saint Petersburg, Sankt-Peterburg, 192148, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 192289, Russia

Location

SPb SBHI City outpatient clinic 112 ( Site 1128)

Saint Petersburg, Sankt-Peterburg, 195427, Russia

Location

Medical Research Institute LLC ( Site 1116)

Saint Petersburg, Sankt-Peterburg, 196084, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 196143, Russia

Location

Smorodintsev Research Institute of Influenza ( Site 1129)

Saint Petersburg, Sankt-Peterburg, 197376, Russia

Location

SPb SBHI City outpatient clinic 4 ( Site 1131)

Saint Petersburg, Sankt-Peterburg, 199406, Russia

Location

Smolensk State Medical University ( Site 1110)

Smolensk, Smolensk Oblast, 214019, Russia

Location

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

Kazan', Tatarstan, Respublika, 420140, Russia

Location

IATROS International ( Site 1212)

Bloemfontein, Free State, 9300, South Africa

Location

Right To Care Research - Esizayo ( Site 1229)

Johannesburg, Gauteng, 2087, South Africa

Location

Mzansi Ethical Research Centre ( Site 1225)

Mpumalanga, Gauteng, 1055, South Africa

Location

Jongaie Research ( Site 1223)

Pretoria West, Gauteng, 0183, South Africa

Location

Wits Baragwanath Clinical Trial Site ( Site 1214)

Soweto, Gauteng, 2013, South Africa

Location

Enhancing Care Foundation-DICRS ( Site 1216)

Durban, KwaZulu-Natal, 4091, South Africa

Location

Limpopo Clinical Research Initiative ( Site 1227)

Thabazimbi, Limpopo, 0380, South Africa

Location

TREAD Research ( Site 1211)

Cape Town, Western Cape, 7500, South Africa

Location

Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219)

Cape Town, Western Cape, 7925, South Africa

Location

Be Part Yoluntu Centre ( Site 1218)

Paarl, Western Cape, 7626, South Africa

Location

Paarl Research Centre ( Site 1228)

Paarl, Western Cape, 7646, South Africa

Location

Clinical Projects Research Centre ( Site 1215)

Worcester, Western Cape, 6850, South Africa

Location

CAP Centelles ( Site 1308)

Centelles, Barcelona, 08540, Spain

Location

Fundacion Hospital Alcorcon de Madrid ( Site 1314)

Alcorcón, Madrid, 28922, Spain

Location

Hospital General Universitario Gregorio Maranon ( Site 1302)

Madrid, Madrid, Comunidad de, 28007, Spain

Location

CAP Sardenya - Barcelona ( Site 1307)

Barcelona, 08025, Spain

Location

Hospital Clinic ( Site 1304)

Barcelona, 08036, Spain

Location

Hospital Universitari Germans Trias i Pujol ( Site 1303)

Barcelona, 08916, Spain

Location

Hospital Universitario Infanta Leonor ( Site 1310)

Madrid, 28031, Spain

Location

Hospital Universitario Ramon y Cajal ( Site 1301)

Madrid, 28034, Spain

Location

Hospital Universitario La Paz ( Site 1300)

Madrid, 28046, Spain

Location

Karolinska Universitetssjukhuset Solna ( Site 1400)

Stockholm, Stockholm County, 113 61, Sweden

Location

ClinSmart Sweden AB.Uppsala ( Site 1402)

Uppsala, Uppsala County, 752 37, Sweden

Location

Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)

Gothenburg, Västra Götaland County, 416 85, Sweden

Location

National Taiwan University Hospital ( Site 3100)

Taipei, 100, Taiwan

Location

Taoyuan General Hospital ( Site 3101)

Taoyuan District, 33004, Taiwan

Location

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76007, Ukraine

Location

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

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

Kharkiv, Kharkivs’ka Oblast’, 61002, Ukraine

Location

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

Kharkiv, Kharkivs’ka Oblast’, 61172, Ukraine

Location

Limited Liability Company Medical center Healthy Happy ( Site 1625)

Kyiv, Kyivska Oblast, 01033, Ukraine

Location

LLC "Adonis plus" ( Site 1619)

Kyiv, Kyivska Oblast, 02002, Ukraine

Location

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

Kyiv, Kyivska Oblast, 03049, Ukraine

Location

ARTEM. State Holding Company ( Site 1618)

Kyiv, Kyivska Oblast, 04050, Ukraine

Location

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

Lviv, Lviv Oblast, 79011, Ukraine

Location

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

Odesa, Odesa Oblast, 65025, Ukraine

Location

Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614)

Poltava, Poltava Oblast, 36011, Ukraine

Location

Medical Center Health Clinic ( Site 1623)

Vinnytsia, Vinnytsia Oblast, 21009, Ukraine

Location

The Adam Practice ( Site 1708)

Poole, Dorset, BH15 2HX, United Kingdom

Location

Accellacare South London Quality Research Centre ( Site 1709)

Orpington, Kent, BR5 3QG, United Kingdom

Location

Royal Free London NHS Foundation Trust ( Site 1700)

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

Location

King's College Hospital ( Site 1707)

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

Location

Layton Medical Centre ( Site 1705)

Blackpool, FY3 7EN, United Kingdom

Location

Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704)

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Related Publications (9)

• 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. Phase 2/3 Trial of Molnupiravir for Treatment of Covid-19 in Nonhospitalized Adults. NEJM Evid. 2022 Feb;1(2):EVIDoa2100043. doi: 10.1056/EVIDoa2100043. Epub 2021 Dec 16.

  PMID: 38319179 RESULT

• Johnson MG, Strizki JM, Hilbert DW, Zhang Y, Carmelitano P, Brown ML, Wolf DJ, Paschke A, De Anda CS. Impact of baseline humoral immunity on treatment outcomes with molnupiravir in the MOVe-OUT randomized, controlled trial. Virology. 2026 Jan;613:110710. doi: 10.1016/j.virol.2025.110710. Epub 2025 Oct 9.

  PMID: 41125063 DERIVED

• Caraco Y, Johnson MG, Chiarappa JA, Maas BM, Stone JA, Rizk ML, Vesnesky M, Strizki JM, Williams-Diaz A, Brown ML, Carmelitano P, Wan H, Pedley A, Chawla A, Wolf DJ, Grobler JA, Paschke A, De Anda C. Impact of differences between interim and post-interim analysis populations on outcomes of a group sequential trial: Example of the MOVe-OUT study. Clin Trials. 2025 Jun;22(3):312-324. doi: 10.1177/17407745251313925. Epub 2025 Mar 2.

  PMID: 40025641 DERIVED

• Strizki JM, Grobler JA, Murgolo N, Fridman A, Johnson MG, Du J, Carmelitano P, Brown ML, Paschke A, De Anda C. Virologic Outcomes with Molnupiravir in Non-hospitalized Adult Patients with COVID-19 from the Randomized, Placebo-Controlled MOVe-OUT Trial. Infect Dis Ther. 2023 Dec;12(12):2725-2743. doi: 10.1007/s40121-023-00891-1. Epub 2023 Nov 23.

  PMID: 37995070 DERIVED

• Guan Y, Puenpatom A, Johnson MG, Zhang Y, Zhao Y, Surber J, Weinberg A, Brotons C, Kozlov R, Lopez R, Coetzee K, Santiaguel J, Du J, Williams-Diaz A, Brown M, Paschke A, De Anda C, Norquist JM. Impact of Molnupiravir Treatment on Patient-Reported COVID-19 Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo-Controlled Trial. Clin Infect Dis. 2023 Nov 30;77(11):1521-1530. doi: 10.1093/cid/ciad409.

  PMID: 37466374 DERIVED

• Chawla A, Birger R, Wan H, Cao Y, Maas BM, Paschke A, De Anda C, Rizk ML, Stone JA. Factors Influencing COVID-19 Risk: Insights From Molnupiravir Exposure-Response Modeling of Clinical Outcomes. Clin Pharmacol Ther. 2023 Jun;113(6):1337-1345. doi: 10.1002/cpt.2895. Epub 2023 Apr 27.

  PMID: 37017631 DERIVED

• Johnson MG, Strizki JM, Brown ML, Wan H, Shamsuddin HH, Ramgopal M, Florescu DF, Delobel P, Khaertynova I, Flores JF, Fouche LF, Chang SC, Williams-Diaz A, Du J, Grobler JA, Paschke A, De Anda C. Molnupiravir for the treatment of COVID-19 in immunocompromised participants: efficacy, safety, and virology results from the phase 3 randomized, placebo-controlled MOVe-OUT trial. Infection. 2023 Oct;51(5):1273-1284. doi: 10.1007/s15010-022-01959-9. Epub 2023 Jan 17.

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• Johnson MG, Puenpatom A, Moncada PA, Burgess L, Duke ER, Ohmagari N, Wolf T, Bassetti M, Bhagani S, Ghosn J, Zhang Y, Wan H, Williams-Diaz A, Brown ML, Paschke A, De Anda C. Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 : A Randomized, Placebo-Controlled Trial. Ann Intern Med. 2022 Aug;175(8):1126-1134. doi: 10.7326/M22-0729. Epub 2022 Jun 7.

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• Jayk Bernal A, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, Martin-Quiros A, Caraco Y, Williams-Diaz A, Brown ML, Du J, Pedley A, Assaid C, Strizki J, Grobler JA, Shamsuddin HH, Tipping R, Wan H, Paschke A, Butterton JR, Johnson MG, De Anda C; MOVe-OUT Study Group. Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med. 2022 Feb 10;386(6):509-520. doi: 10.1056/NEJMoa2116044. Epub 2021 Dec 16.

  PMID: 34914868 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

molnupiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 5, 2020
• Study Start: October 19, 2020
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (3); US (32); RU (15); SE (3); GB (6); EG (5); CA (4); IL (1); CO (10); AR (2); UA (13); GU (2); IT (11); PL (4); ZA (12); BR (7); FR (8); PH (2); TW (2); ES (9); ME (11); DE (4); CL (7)