AzTrials
AzTrials

Coronavirus Disease (COVID-19)Phase 2/3NCT04575597

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

A Phase 2/3 study testing Molnupiravir in people with Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 173 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Disease (COVID-19)
What is being tested?
Molnupiravir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,735 participants
Where
173 sitesin 23 countries
Study dates
19 Oct 2020to 5 May 2022
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

173 sites in 23 countries.

173 sites in 23 countries

United States32 sites

  • Javara Inc. ( Site 1869)

    Albany, Georgia, 31707

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

    Albuquerque, New Mexico, 87131

  • JEM Research Institute ( Site 2508)

    Atlantis, Florida, 33462

  • Saint Hope Foundation, Inc. ( Site 1830)

    Bellaire, Texas, 77401

  • Loretto Hospital ( Site 1886)

    Chicago, Illinois, 60644

  • IACT Health ( Site 1818)

    Columbus, Georgia, 31904

  • Michigan Center of Medical Research ( Site 2500)

    Farmington Hills, Michigan, 48334

  • Javara Inc. ( Site 1868)

    Fayetteville, Georgia, 30214

  • Midway Immunology and Research Center ( Site 1837)

    Ft. Pierce, Florida, 34982

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

    Hialeah, Florida, 33012

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

    Houston, Texas, 77098

  • Advanced Research For Health Improvement LLC ( Site 1816)

    Immokalee, Florida, 34142

  • Jadestone Clinical Research, LLC ( Site 2502)

    Laurel, Maryland, 20708

  • Ruane Clinical Research Group, Inc. ( Site 2406)

    Los Angeles, California, 90036

  • Men's Health Foundation ( Site 1820)

    Los Angeles, California, 90069

  • Advanced Medical Research, LLC ( Site 1864)

    Miami, Florida, 33174

  • Medical College Of Wisconsin ( Site 2510)

    Milwaukee, Wisconsin, 53226

  • Advanced Research For Health Improvement LLC ( Site 1813)

    Naples, Florida, 34102

  • Carbon Health Technologies Inc ( Site 2505)

    North Hollywood, California, 91606

  • University of Nebraska Medical Center ( Site 2414)

    Omaha, Nebraska, 68198

  • Bliss Healthcare Services ( Site 1847)

    Orlando, Florida, 32806

  • Phoenix Medical Group ( Site 1822)

    Peoria, Arizona, 85381

  • Amici Clinical Research LLC ( Site 2507)

    Raritan, New Jersey, 08869

  • Clinical Research Partners, LLC. ( Site 2503)

    Richmond, Virginia, 23226

  • UC Davis Medical Center ( Site 1833)

    Sacramento, California, 95817

  • AXCES Research Group ( Site 2418)

    Santa Fe, New Mexico, 87505

  • Swedish Medical Center First Hill ( Site 1807)

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Center ( Site 1829)

    Seattle, Washington, 98109

  • Multicare Health System ( Site 1811)

    Spokane, Washington, 99204

  • Javara Inc. ( Site 1866)

    Sugar Land, Texas, 77478

  • Multicare Health System ( Site 1814)

    University Place, Washington, 98466

  • Emerson Clinical Research Institute ( Site 1828)

    Washington D.C., District of Columbia, 20011

Other trials in United States

Russia15 sites

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

    Kazan', Tatarstan, Respublika, 420140

  • Central Scientific Research Institute of Epidemiology ( Site 1104)

    Moscow, Moscow, 111123

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

    Moscow, Moscow, 115419

  • Hadassah Medical LTD ( Site 1124)

    Moscow, Moscow, 121205

  • Central Clinical Hospital with Polyclinic ( Site 1105)

    Moscow, Moscow, 121359

  • City Hospital No.33 of Leninsky ( Site 1127)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603076

  • City Polyclinic N44 ( Site 1130)

    Saint Petersburg, Sankt-Peterburg, 192071

  • Strategic Medical System LLC ( Site 1114)

    Saint Petersburg, Sankt-Peterburg, 192148

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

    Saint Petersburg, Sankt-Peterburg, 192289

  • SPb SBHI City outpatient clinic 112 ( Site 1128)

    Saint Petersburg, Sankt-Peterburg, 195427

  • Medical Research Institute LLC ( Site 1116)

    Saint Petersburg, Sankt-Peterburg, 196084

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

    Saint Petersburg, Sankt-Peterburg, 196143

  • Smorodintsev Research Institute of Influenza ( Site 1129)

    Saint Petersburg, Sankt-Peterburg, 197376

  • SPb SBHI City outpatient clinic 4 ( Site 1131)

    Saint Petersburg, Sankt-Peterburg, 199406

  • Smolensk State Medical University ( Site 1110)

    Smolensk, Smolensk Oblast, 214019

Other trials in Russia

Ukraine13 sites

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

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76007

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

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

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

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

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

    Kharkiv, Kharkiv Oblast, 61002

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

    Kharkiv, Kharkiv Oblast, 61172

  • Limited Liability Company Medical center Healthy Happy ( Site 1625)

    Kyiv, Kyivska Oblast, 01033

  • LLC "Adonis plus" ( Site 1619)

    Kyiv, Kyivska Oblast, 02002

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

    Kyiv, Kyivska Oblast, 03049

  • ARTEM. State Holding Company ( Site 1618)

    Kyiv, Kyivska Oblast, 04050

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

    Lviv, Lviv Oblast, 79011

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

    Odesa, Odesa Oblast, 65025

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

    Poltava, Poltava Oblast, 36011

  • Medical Center Health Clinic ( Site 1623)

    Vinnytsia, Vinnytsia Oblast, 21009

Other trials in Ukraine

South Africa12 sites

  • IATROS International ( Site 1212)

    Bloemfontein, Free State, 9300

  • TREAD Research ( Site 1211)

    Cape Town, Western Cape, 7500

  • Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219)

    Cape Town, Western Cape, 7925

  • Enhancing Care Foundation-DICRS ( Site 1216)

    Durban, KwaZulu-Natal, 4091

  • Right To Care Research - Esizayo ( Site 1229)

    Johannesburg, Gauteng, 2087

  • Mzansi Ethical Research Centre ( Site 1225)

    Mpumalanga, Gauteng, 1055

  • Be Part Yoluntu Centre ( Site 1218)

    Paarl, Western Cape, 7626

  • Paarl Research Centre ( Site 1228)

    Paarl, Western Cape, 7646

  • Jongaie Research ( Site 1223)

    Pretoria West, Gauteng, 0183

  • Wits Baragwanath Clinical Trial Site ( Site 1214)

    Soweto, Gauteng, 2013

  • Limpopo Clinical Research Initiative ( Site 1227)

    Thabazimbi, Limpopo, 0380

  • Clinical Projects Research Centre ( Site 1215)

    Worcester, Western Cape, 6850

Other trials in South Africa

Italy11 sites

  • Policlinico S. Orsola-Malpighi ( Site 0604)

    Bologna, 40138

  • IRCCS Ospedale Policlinico San Martino ( Site 0603)

    Genova, 16132

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

    Milan, 20122

  • Ospedale San Raffaele ( Site 0605)

    Milan, 20127

  • ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

    Milan, 20157

  • Ospedale Niguarda ( Site 0608)

    Milan, 20162

  • Asl Napoli 1 Centro ( Site 0610)

    Naples, Napoli, 80145

  • AOU Policlinico Paolo Giaccone ( Site 0609)

    Palermo, 90127

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

    Roma, 00149

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

    Torino, 10149

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

    Udine, 33100

Other trials in Italy

Mexico11 sites

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

    Cancún, Quintana Roo, 70500

  • ICARO Investigaciones en Medicina ( Site 0812)

    Chihuahua City, 31000

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

    Guadalajara, Jalisco, 44280

  • Hospital Regional de Alta Especialidad del Bajio ( Site 0807)

    León, Guanajuato, 37660

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

    Mérida, Yucatán, 97070

  • CAIMED México ( Site 0814)

    Mexico City, Mexico City, 06760

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

    Mexico City, Mexico City, 14080

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)

    Monterrey, Nuevo León, 64460

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

    Oaxaca City, 68000

  • Clinical Research Institute S.C. ( Site 0813)

    Tlalnepantla, 54055

  • Arké SMO S.A de C.V ( Site 0808)

    Veracruz, 91910

Other trials in Mexico

Colombia10 sites

  • Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)

    Barranquilla, Atlántico, 080020

  • Clinica de la Costa Ltda. ( Site 0403)

    Barranquilla, Atlántico, 080020

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

    Bogota, Cundinamarca, 111211

  • Centro de Atencion e Investigacion Medica CAIMED ( Site 0413)

    Bogota, Cundinamarca, 111611

  • Fundacion Santa Fe de Bogota ( Site 0412)

    Bogotá, Bogota D.C., 110111

  • Fundacion Cardiovascular de Colombia ( Site 0402)

    Bucaramanca, Santander Department, 680003

  • Fundacion Valle del Lili ( Site 0401)

    Cali, Valle del Cauca Department, 760032

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

    Cali, Valle del Cauca Department, 760042

  • Hospital Pablo Tobon Uribe ( Site 0405)

    Medellín, Antioquia, 050034

  • Oncomedica S.A. ( Site 0407)

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

Spain9 sites

  • Fundacion Hospital Alcorcon de Madrid ( Site 1314)

    Alcorcón, Madrid, 28922

  • CAP Sardenya - Barcelona ( Site 1307)

    Barcelona, 08025

  • Hospital Clinic ( Site 1304)

    Barcelona, 08036

  • Hospital Universitari Germans Trias i Pujol ( Site 1303)

    Barcelona, 08916

  • CAP Centelles ( Site 1308)

    Centelles, Barcelona, 08540

  • Hospital General Universitario Gregorio Maranon ( Site 1302)

    Madrid, Madrid, Comunidad de, 28007

  • Hospital Universitario Infanta Leonor ( Site 1310)

    Madrid, 28031

  • Hospital Universitario Ramon y Cajal ( Site 1301)

    Madrid, 28034

  • Hospital Universitario La Paz ( Site 1300)

    Madrid, 28046

Other trials in Spain

France8 sites

  • Groupe Hospitalier Pellegrin ( Site 0511)

    Bordeaux, Gironde, 33000

  • Hopital Saint Joseph ( Site 0513)

    Marseille, Bouches-du-Rhone, 13285

  • Hopital Bichat Claude Bernard ( Site 0503)

    Paris, Ain, 75018

  • CHU Hopital Saint Antoine ( Site 0505)

    Paris, 75012

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

    Paris, 75013

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

    Saint-Pierre, La Reunion, 97448

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

    Toulouse, Midi-Pyrenees, 31059

  • Centre Hospitalier de Tourcoing ( Site 0502)

    Tourcoing, Nord, 59208

Other trials in France

Brazil7 sites

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

    Belo Horizonte, Minas Gerais, 30150-221

  • Hospital Tacchini ( Site 0157)

    Bento Gonçalves, Rio Grande do Sul, 95700-000

  • Chronos Pesquisa Clínica ( Site 0155)

    Brasília, Federal District, 72145-424

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

    Curitiba, Paraná, 80060-900

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

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

  • Instituto de Infectologia Emilio Ribas ( Site 0153)

    São Paulo, 01246-900

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

    São Paulo, 05403-010

Other trials in Brazil

Chile7 sites

  • Servicios Medicos Urumed ( Site 0307)

    Rancagua, Lbtdr Gen Bernardo O Higgins, 2852424

  • Clinica Universidad de los Andes ( Site 0302)

    Santiago, Region M. de Santiago, 2820945

  • Fundacion Arturo Lopez Perez ( Site 0305)

    Santiago, Region M. de Santiago, 7500921

  • Espacio EME ( Site 0304)

    Santiago, Region M. de Santiago, 7770086

  • Centro de Investigacion Clinica UC CICUC ( Site 0309)

    Santiago, Region M. de Santiago, 8330034

  • Clinica Bicentenario Spa ( Site 0306)

    Santiago, Region M. de Santiago, 9160000

  • Clinical Research Chile SpA ( Site 0308)

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

United Kingdom6 sites

  • Layton Medical Centre ( Site 1705)

    Blackpool, FY3 7EN

  • Royal Free London NHS Foundation Trust ( Site 1700)

    London, London, City of, NW3 2QG

  • King's College Hospital ( Site 1707)

    London, London, City of, SE5 9RS

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

    Newcastle upon Tyne, NE1 4LP

  • Accellacare South London Quality Research Centre ( Site 1709)

    Orpington, Kent, BR5 3QG

  • The Adam Practice ( Site 1708)

    Poole, Dorset, BH15 2HX

Other trials in United Kingdom

Egypt5 sites

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

    Cairo, Cairo Governorate, 11562

  • Abbassia Chest Hospital ( Site 3340)

    Cairo, Cairo Governorate, 11591

  • Abbassia Fever Hospital ( Site 3330)

    Cairo, Cairo Governorate, 11591

  • Helwan Fever Hospital ( Site 3350)

    Cairo, Cairo Governorate, 12899

  • National Center for allergies and chest ( Site 3320)

    Giza, Giza Governorate, 12651

Other trials in Egypt

Canada4 sites

  • Hamilton Medical Research Group ( Site 0207)

    Hamilton, Ontario, L8M1K7

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

    Montreal, Quebec, H2X 3E4

  • McGill University Health Centre ( Site 0204)

    Montreal, Quebec, H4A 3J1

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

    Toronto, Ontario, M5G 2N2

Other trials in Canada

Germany4 sites

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

    Berlin, 10439

  • Universitaetsklinikum Essen ( Site 2305)

    Essen, North Rhine-Westphalia, 45147

  • Universitaetsklinikum Frankfurt ( Site 2302)

    Frankfurt A Main, Hesse, 60590

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

    Hamburg, 20146

Other trials in Germany

Poland4 sites

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

    Krakow, Lesser Poland Voivodeship, 31-501

  • NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)

    Lodz, Łódź Voivodeship, 90-302

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

    Piaseczno, Masovian Voivodeship, 05-500

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

    Rzeszów, Podkarpackie Voivodeship, 35-326

Other trials in Poland

Japan3 sites

  • Chiba Aoba Municipal Hospital ( Site 0702)

    Chiba, 260-0852

  • Den-en-chofu family clinic ( Site 0701)

    Tokyo, 145-0071

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

    Tokyo, 162-8655

Other trials in Japan

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)

    Gothenburg, Västra Götaland County, 416 85

  • Karolinska Universitetssjukhuset Solna ( Site 1400)

    Stockholm, Stockholm County, 113 61

  • ClinSmart Sweden AB.Uppsala ( Site 1402)

    Uppsala, Uppsala County, 752 37

Other trials in Sweden

Argentina2 sites

  • Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)

    Rosario, Santa Fe Province, 2000

  • Clinica Independencia ( Site 3400)

    Vicente López, Buenos Aires, B1605FRE

Other trials in Argentina

Guatemala2 sites

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

    Guatemala City, 01009

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

    Guatemala City, 01015

Other trials in Guatemala

Philippines2 sites

  • Lung Center of the Philippines ( Site 0902)

    Quezon City, National Capital Region, 1100

  • Quirino Memorial Medical Center ( Site 0903)

    Quezon City, National Capital Region, 1109

Other trials in Philippines

Taiwan2 sites

  • National Taiwan University Hospital ( Site 3100)

    Taipei, 100

  • Taoyuan General Hospital ( Site 3101)

    Taoyuan, 33004

Other trials in Taiwan

Israel1 site

  • Hadassah Medical Center. Ein Kerem ( Site 2100)

    Jerusalem, 9112001

Other trials in Israel

About this study

Official title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.

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

Being tested
Molnupiravir, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MolnupiravirDrug

    Also called MK-4482

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

  • PlaceboDrug

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

Study groups in NCT04575597
Study groupRoleWhat they receive
Part 1: Molnupiravir 200 mgExperimental200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Molnupiravir
Part 1: Molnupiravir 400 mgExperimental400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Molnupiravir
Part 1: Molnupiravir 800 mgExperimental800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Molnupiravir
Part 1: PlaceboPlacebo comparatorPlacebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Placebo
Part 2: Molnupiravir 800 mgExperimental800 mg Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Molnupiravir
Part 2: PlaceboPlacebo comparatorPlacebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 29 days

  2. 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.

    Measured: Up to 318 days

  3. 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.

    Measured: Up to 5 days

Secondary outcomes (35)

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

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

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

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

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

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

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

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

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

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

  6. Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

  7. Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

  8. Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

  9. Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

  10. Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

  11. Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

  12. Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

  13. Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

  14. Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

  15. Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell

    Time to sustained resolution or improvement of the targeted sign/symptom was defined as the number of days from randomization to the first of three consecutive days when resolution or improvement of the targeted sign/symptom was demonstrated and did not worsen by Day 29. The median number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement is presented. Per protocol, participants without the targeted sign/symptom reported at randomization were not included in the analysis.

    Measured: Up to 29 days

  16. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  17. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  18. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  19. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  20. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  21. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  22. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  23. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  24. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  25. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  26. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  27. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  28. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  29. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  30. Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell

    Time to progression of the targeted sign/symptom was defined as the number of days from randomization to the first of two consecutive days when the targeted sign/symptom was worsened. The median number of days from randomization to the first day on or before study Day 29 for progression/worsening is presented. Per protocol, participants with symptoms reported at randomization as severe for the targeted sign/symptom were not included in the analysis.

    Measured: Up to 29 days

  31. Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3

    The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.

    Measured: Day 3

  32. Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5])

    The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.

    Measured: EOT (Day 5)

  33. Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10

    The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.

    Measured: Day 10

  34. Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15

    The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.

    Measured: Day 15

  35. Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29

    The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 ("uninfected") to 10 ("dead") with higher score indicating clinical progression. The number of participants at each score category is presented.

    Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start19 Oct 2020
  3. Primary completion5 May 2022
  4. Study completion5 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,735 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04575597
Sponsor's protocol ID
4482-002
Other IDs
MK-4482-002, PHRR201209-003186, jRCT2031210148, 2020-003368-24
Status last verified
May 2023
First submitted
30 Sep 2020
Last updated
28 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 38319179

  • 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.

    PubMed 41125063

  • 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.

    PubMed 40025641

  • 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.

    PubMed 37995070

  • 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.

    PubMed 37466374

  • 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.

    PubMed 37017631

  • 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.

    PubMed 36648627

  • 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.

    PubMed 35667065

  • 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.

    PubMed 34914868

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Molnupiravir in people with Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 173 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 173 sites in United States, Russia, Ukraine, South Africa, Italy and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis) (time frame: Up to 29 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04575597, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.

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