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

NCT ID: NCT04575597

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1735 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2022-05-05

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1: Molnupiravir 200 mg

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

Group Type: EXPERIMENTAL

Molnupiravir

Intervention Type: DRUG

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

Part 1: Molnupiravir 400 mg

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

Group Type: EXPERIMENTAL

Molnupiravir

Intervention Type: DRUG

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

Part 1: Molnupiravir 800 mg

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

Group Type: EXPERIMENTAL

Molnupiravir

Intervention Type: DRUG

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

Part 1: Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Part 2: Molnupiravir 800 mg

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

Group Type: EXPERIMENTAL

Molnupiravir

Intervention Type: DRUG

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

Part 2: Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Molnupiravir

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

MK-4482

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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 D.C., District of Columbia, United States

JEM Research Institute ( Site 2508)

Atlantis, Florida, United States

Midway Immunology and Research Center ( Site 1837)

Ft. 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 López, Buenos Aires, Argentina

Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)

Rosario, Santa Fe Province, Argentina

Chronos Pesquisa Clínica ( Site 0155)

Brasília, Federal District, 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, Paraná, Brazil

Hospital Tacchini ( Site 0157)

Bento Gonçalves, Rio Grande do Sul, Brazil

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

São José do Rio Preto, São Paulo, Brazil

Instituto de Infectologia Emilio Ribas ( Site 0153)

São Paulo, , Brazil

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

São 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 Ríos Region, 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)

Medellín, Antioquia, Colombia

Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)

Barranquilla, Atlántico, Colombia

Clinica de la Costa Ltda. ( Site 0403)

Barranquilla, Atlántico, Colombia

Fundacion Santa Fe de Bogota ( Site 0412)

Bogotá, Bogota D.C., 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

Oncomedica S.A. ( Site 0407)

Montería, Departamento de Córdoba, Colombia

Fundacion Cardiovascular de Colombia ( Site 0402)

Bucaramanca, Santander Department, Colombia

Fundacion Valle del Lili ( Site 0401)

Cali, Valle del Cauca Department, Colombia

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

Cali, Valle del Cauca Department, Colombia

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

Cairo, Cairo Governorate, Egypt

Abbassia Chest Hospital ( Site 3340)

Cairo, Cairo Governorate, Egypt

Abbassia Fever Hospital ( Site 3330)

Cairo, Cairo Governorate, Egypt

Helwan Fever Hospital ( Site 3350)

Cairo, Cairo Governorate, Egypt

National Center for allergies and chest ( Site 3320)

Giza, Giza Governorate, 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, 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, Hesse, Germany

Universitaetsklinikum Essen ( Site 2305)

Essen, North Rhine-Westphalia, 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 City, , Guatemala

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

Guatemala City, , Guatemala

Hadassah Medical Center. Ein Kerem ( Site 2100)

Jerusalem, , Israel

Asl Napoli 1 Centro ( Site 0610)

Naples, 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)

Milan, , Italy

Ospedale San Raffaele ( Site 0605)

Milan, , Italy

ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

Milan, , Italy

Ospedale Niguarda ( Site 0608)

Milan, , 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

Hospital Regional de Alta Especialidad del Bajio ( Site 0807)

León, Guanajuato, Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

Guadalajara, Jalisco, Mexico

CAIMED México ( Site 0814)

Mexico City, Mexico City, Mexico

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

Mexico City, Mexico City, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)

Monterrey, Nuevo León, Mexico

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

Cancún, Quintana Roo, Mexico

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

Mérida, Yucatán, Mexico

ICARO Investigaciones en Medicina ( Site 0812)

Chihuahua City, , Mexico

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

Oaxaca City, , Mexico

Clinical Research Institute S.C. ( Site 0813)

Tlalnepantla, , 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

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

Krakow, Lesser Poland Voivodeship, Poland

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

Piaseczno, Masovian Voivodeship, Poland

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

Rzeszów, Podkarpackie Voivodeship, Poland

NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)

Lodz, Łódź Voivodeship, Poland

Central Scientific Research Institute of Epidemiology ( Site 1104)

Moscow, Moscow, Russia

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

Moscow, Moscow, Russia

Hadassah Medical LTD ( Site 1124)

Moscow, Moscow, Russia

Central Clinical Hospital with Polyclinic ( Site 1105)

Moscow, Moscow, Russia

City Hospital No.33 of Leninsky ( Site 1127)

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

City Polyclinic N44 ( Site 1130)

Saint Petersburg, Sankt-Peterburg, Russia

Strategic Medical System LLC ( Site 1114)

Saint Petersburg, Sankt-Peterburg, Russia

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

Saint Petersburg, Sankt-Peterburg, Russia

SPb SBHI City outpatient clinic 112 ( Site 1128)

Saint Petersburg, Sankt-Peterburg, Russia

Medical Research Institute LLC ( Site 1116)

Saint Petersburg, Sankt-Peterburg, Russia

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

Saint Petersburg, Sankt-Peterburg, Russia

Smorodintsev Research Institute of Influenza ( Site 1129)

Saint Petersburg, Sankt-Peterburg, Russia

SPb SBHI City outpatient clinic 4 ( Site 1131)

Saint Petersburg, Sankt-Peterburg, Russia

Smolensk State Medical University ( Site 1110)

Smolensk, Smolensk Oblast, Russia

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

Kazan', Tatarstan, Respublika, Russia

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

Fundacion Hospital Alcorcon de Madrid ( Site 1314)

Alcorcón, Madrid, Spain

Hospital General Universitario Gregorio Maranon ( Site 1302)

Madrid, Madrid, Comunidad de, 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, Stockholm County, Sweden

ClinSmart Sweden AB.Uppsala ( Site 1402)

Uppsala, Uppsala County, Sweden

Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)

Gothenburg, Västra Götaland County, Sweden

National Taiwan University Hospital ( Site 3100)

Taipei, , Taiwan

Taoyuan General Hospital ( Site 3101)

Taoyuan District, , Taiwan

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

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

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

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

Kharkiv, Kharkivs’ka 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, Lviv Oblast, Ukraine

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

Odesa, Odesa Oblast, Ukraine

Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614)

Poltava, Poltava Oblast, Ukraine

Medical Center Health Clinic ( Site 1623)

Vinnytsia, Vinnytsia 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

Countries

United States; Argentina; Brazil; Canada; Chile; Colombia; Egypt; France; Germany; Guatemala; Israel; Italy; Japan; Mexico; Philippines; Poland; Russia; South Africa; Spain; Sweden; Taiwan; Ukraine; United Kingdom

References

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Reference Type: RESULT

PMID: 38319179 (View on PubMed)

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. 2025 Oct 9;613:110710. doi: 10.1016/j.virol.2025.110710. Online ahead of print.

Reference Type: DERIVED

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Reference Type: DERIVED

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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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 37017631 (View on PubMed)

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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 35667065 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34914868 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MK-4482-002

Identifier Type: OTHER

Identifier Source: secondary_id

PHRR201209-003186

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2031210148

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-003368-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

4482-002

Identifier Type: -

Identifier Source: org_study_id