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

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

Study Overview

• Status: Completed
• Conditions: Coronavirus Disease (COVID-19)
• Intervention / Treatment: Drug: Molnupiravir; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1735
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Vicente Lopez, Buenos Aires, Argentina, B1605FRE
      • Clinica Independencia ( Site 3400)
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)
• Brazil
  • Sao Paulo, Brazil, 01246-900
    • Instituto de Infectologia Emilio Ribas ( Site 0153)
  • Sao Paulo, Brazil, 05403-010
    • Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152)
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 72145-424
      • Chronos Pesquisa Clínica ( Site 0155)
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Santa Casa de Misericordia de Belo Horizonte ( Site 0150)
  • Parana
    • Curitiba, Parana, Brazil, 80060-900
      • Hospital de Clinicas da Universidade Federal do Parana ( Site 0154)
  • Rio Grande Do Sul
    • Bento Goncalves, Rio Grande Do Sul, Brazil, 95700-000
      • Hospital Tacchini ( Site 0157)
  • Sao Paulo
    • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
      • FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151)
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8M1K7
      • Hamilton Medical Research Group ( Site 0207)
    • Toronto, Ontario, Canada, M5G 2N2
      • University Health Network - Toronto General Hospital ( Site 0201)
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre ( Site 0204)
• Chile
  • Lbtdr Gen Bernardo O Higgins
    • Rancagua, Lbtdr Gen Bernardo O Higgins, Chile, 2852424
      • Servicios Medicos Urumed ( Site 0307)
  • Los Rios
    • Valdivia, Los Rios, Chile, 5110683
      • Clinical Research Chile SpA ( Site 0308)
  • Region M. De Santiago
    • Santiago, Region M. De Santiago, Chile, 2820945
      • Clinica Universidad de los Andes ( Site 0302)
    • Santiago, Region M. De Santiago, Chile, 7500921
      • Fundacion Arturo Lopez Perez ( Site 0305)
    • Santiago, Region M. De Santiago, Chile, 7770086
      • Espacio EME ( Site 0304)
    • Santiago, Region M. De Santiago, Chile, 8330034
      • Centro de Investigacion Clinica UC CICUC ( Site 0309)
    • Santiago, Region M. De Santiago, Chile, 9160000
      • Clinica Bicentenario Spa ( Site 0306)
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050034
      • Hospital Pablo Tobon Uribe ( Site 0405)
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)
    • Barranquilla, Atlantico, Colombia, 080020
      • Clinica de la Costa Ltda. ( Site 0403)
  • Cordoba
    • Monteria, Cordoba, Colombia, 230002
      • Oncomedica S.A. ( Site 0407)
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 111211
      • Caja de Compensación Familiar CAFAM. Sede Centro de Atención en Salud CAFAM Floresta ( Site 0406)
    • Bogota, Cundinamarca, Colombia, 111611
      • Centro de Atencion e Investigacion Medica CAIMED ( Site 0413)
  • Distrito Capital De Bogota
    • Bogota, Distrito Capital De Bogota, Colombia, 110111
      • Fundacion Santa Fe de Bogota ( Site 0412)
  • Santander
    • Bucaramanca, Santander, Colombia, 680003
      • Fundacion Cardiovascular de Colombia ( Site 0402)
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 760032
      • Fundacion Valle del Lili ( Site 0401)
    • Cali, Valle Del Cauca, Colombia, 760042
      • Centro Medico Imbanaco de Cali S.A ( Site 0415)
• Egypt
  • Al Jizah
    • Giza, Al Jizah, Egypt, 12651
      • National Center for allergies and chest ( Site 3320)
  • Al Qahirah
    • Cairo, Al Qahirah, Egypt, 11562
      • National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300)
    • Cairo, Al Qahirah, Egypt, 11591
      • Abbassia Chest Hospital ( Site 3340)
    • Cairo, Al Qahirah, Egypt, 11591
      • Abbassia Fever Hospital ( Site 3330)
    • Cairo, Al Qahirah, Egypt, 12899
      • Helwan Fever Hospital ( Site 3350)
• France
  • Paris, France, 75012
    • CHU Hopital Saint Antoine ( Site 0505)
  • Paris, France, 75013
    • Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)
  • Ain
    • Paris, Ain, France, 75018
      • Hopital Bichat Claude Bernard ( Site 0503)
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13285
      • Hopital Saint Joseph ( Site 0513)
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • Groupe Hospitalier Pellegrin ( Site 0511)
  • La Reunion
    • Saint Pierre Cedex, La Reunion, France, 97448
      • CHU de la Reunion - Groupe Hospitalier Sud ( Site 0514)
  • Midi-Pyrenees
    • Toulouse, Midi-Pyrenees, France, 31059
      • C.H.U. de Toulouse Hopital Purpan ( Site 0501)
  • Nord
    • Tourcoing, Nord, France, 59208
      • Centre Hospitalier de Tourcoing ( Site 0502)
• Germany
  • Berlin, Germany, 10439
    • ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301)
  • Hamburg, Germany, 20146
    • ICH Study Center GmbH & Co.KG ( Site 2306)
  • Hessen
    • Frankfurt a main, Hessen, Germany, 60590
      • Universitaetsklinikum Frankfurt ( Site 2302)
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • Universitaetsklinikum Essen ( Site 2305)
• Guatemala
  • Guatemala, Guatemala, 01009
    • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 2601)
  • Guatemala, Guatemala, 01015
    • Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2600)
• Israel
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center. Ein Kerem ( Site 2100)
• Italy
  • Bologna, Italy, 40138
    • Policlinico S. Orsola-Malpighi ( Site 0604)
  • Genova, Italy, 16132
    • IRCCS Ospedale Policlinico San Martino ( Site 0603)
  • Milano, Italy, 20157
    • ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)
  • Milano, Italy, 20122
    • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606)
  • Milano, Italy, 20127
    • Ospedale San Raffaele ( Site 0605)
  • Milano, Italy, 20162
    • Ospedale Niguarda ( Site 0608)
  • Palermo, Italy, 90127
    • AOU Policlinico Paolo Giaccone ( Site 0609)
  • Roma, Italy, 00149
    • Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 0600)
  • Torino, Italy, 10149
    • Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602)
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria Friuli Centrale -ASU FC ( Site 0607)
  • Napoli
    • Napoles, Napoli, Italy, 80145
      • Asl Napoli 1 Centro ( Site 0610)
• Japan
  • Chiba, Japan, 260-0852
    • Chiba Aoba Municipal Hospital ( Site 0702)
  • Tokyo, Japan, 145-0071
    • Den-en-chofu family clinic ( Site 0701)
  • Tokyo, Japan, 162-8655
    • Center Hospital of the National Center for Global Health and Medicine ( Site 0700)
• Mexico
  • Chihuahua, Mexico, 31000
    • ICARO Investigaciones en Medicina ( Site 0812)
  • Oaxaca, Mexico, 68000
    • Oaxaca Site Management Organization S.C. ( Site 0811)
  • Tlalnepantla de Baz, Mexico, 54055
    • Clinical Research Institute S.C. ( Site 0813)
  • Veracruz, Mexico, 91910
    • Arké SMO S.A de C.V ( Site 0808)
  • Distrito Federal
    • Ciudad de mexico, Distrito Federal, Mexico, 14080
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)
    • Mexico City, Distrito Federal, Mexico, 06760
      • CAIMED México ( Site 0814)
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37660
      • Hospital Regional de Alta Especialidad del Bajio ( Site 0807)
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)
  • Quintana Roo
    • Cancun, Quintana Roo, Mexico, 70500
      • Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0810)
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Köhler & Milstein Research S.A. de C.V. ( Site 0809)
• Philippines
  • National Capital Region
    • Quezon City, National Capital Region, Philippines, 1100
      • Lung Center of the Philippines ( Site 0902)
    • Quezon City, National Capital Region, Philippines, 1109
      • Quirino Memorial Medical Center ( Site 0903)
• Poland
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-302
      • NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-501
      • Krakowskie Centrum Medyczne Sp. z o.o ( Site 1008)
  • Mazowieckie
    • Piaseczno, Mazowieckie, Poland, 05-500
      • Centrum Medyczne Pulawska Sp. z o.o. ( Site 1007)
  • Podkarpackie
    • Rzeszow, Podkarpackie, Poland, 35-326
      • Centrum Medyczne MEDYK Sp. z o.o. Sp.k. ( Site 1009)
• Russian Federation
  • Moskva
    • Moscow, Moskva, Russian Federation, 111123
      • Central Scientific Research Institute of Epidemiology ( Site 1104)
    • Moscow, Moskva, Russian Federation, 115419
      • Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1122)
    • Moscow, Moskva, Russian Federation, 121205
      • Hadassah Medical LTD ( Site 1124)
    • Moscow, Moskva, Russian Federation, 121359
      • Central Clinical Hospital with Polyclinic ( Site 1105)
  • Nizhegorodskaya Oblast
    • Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603076
      • City Hospital No.33 of Leninsky ( Site 1127)
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 195427
      • SPb SBHI City outpatient clinic 112 ( Site 1128)
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 196084
      • Medical Research Institute LLC ( Site 1116)
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197376
      • Smorodintsev Research Institute of Influenza ( Site 1129)
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 199406
      • SPb SBHI City outpatient clinic 4 ( Site 1131)
    • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 192148
      • Strategic Medical System LLC ( Site 1114)
    • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 192289
      • St.Petersburg Outpatient Clinic No. 109 ( Site 1119)
    • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 196143
      • Limited liability company "Scientific research center Eco-safety" ( Site 1117)
    • St.Petersburg, Sankt-Peterburg, Russian Federation, 192071
      • City Polyclinic N44 ( Site 1130)
  • Smolenskaya Oblast
    • Smolensk, Smolenskaya Oblast, Russian Federation, 214019
      • Smolensk State Medical University ( Site 1110)
  • Tatarstan, Respublika
    • Kazan, Tatarstan, Respublika, Russian Federation, 420140
      • Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9300
      • IATROS International ( Site 1212)
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2087
      • Right To Care Research - Esizayo ( Site 1229)
    • Mpumalanga, Gauteng, South Africa, 1055
      • Mzansi Ethical Research Centre ( Site 1225)
    • Pretoria-West, Gauteng, South Africa, 0183
      • Jongaie Research ( Site 1223)
    • Soweto, Gauteng, South Africa, 2013
      • Wits Baragwanath Clinical Trial Site ( Site 1214)
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4091
      • Enhancing Care Foundation-DICRS ( Site 1216)
  • Limpopo
    • Thabazimbi, Limpopo, South Africa, 0380
      • Limpopo Clinical Research Initiative ( Site 1227)
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7500
      • TREAD Research ( Site 1211)
    • Cape Town, Western Cape, South Africa, 7925
      • Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219)
    • Paarl, Western Cape, South Africa, 7626
      • Be Part Yoluntu Centre ( Site 1218)
    • Paarl, Western Cape, South Africa, 7646
      • Paarl Research Centre ( Site 1228)
    • Worcester, Western Cape, South Africa, 6850
      • Clinical Projects Research Centre ( Site 1215)
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic ( Site 1304)
  • Barcelona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol ( Site 1303)
  • Barcelona, Spain, 08025
    • CAP Sardenya - Barcelona ( Site 1307)
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal ( Site 1301)
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz ( Site 1300)
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor ( Site 1310)
  • Barcelona
    • Centelles, Barcelona, Spain, 08540
      • CAP Centelles ( Site 1308)
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Fundacion Hospital Alcorcon de Madrid ( Site 1314)
  • Madrid, Comunidad De
    • Madrid, Madrid, Comunidad De, Spain, 28007
      • Hospital General Universitario Gregorio Maranon ( Site 1302)
• Sweden
  • Stockholms Lan
    • Stockholm, Stockholms Lan, Sweden, 113 61
      • Karolinska Universitetssjukhuset Solna ( Site 1400)
  • Uppsala Lan
    • Uppsala, Uppsala Lan, Sweden, 752 37
      • ClinSmart Sweden AB.Uppsala ( Site 1402)
  • Vastra Gotalands Lan
    • Goteborg, Vastra Gotalands Lan, Sweden, 416 85
      • Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)
• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital ( Site 3100)
  • Taoyuan, Taiwan, 33004
    • Taoyuan General Hospital ( Site 3101)
• Ukraine
  • Ivano-Frankivska Oblast
    • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76007
      • Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)
    • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
      • CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)
    • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
      • MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)
  • Kharkivska Oblast
    • Kharkiv, Kharkivska Oblast, Ukraine, 61002
      • Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 1621)
    • Kharkiv, Kharkivska Oblast, Ukraine, 61172
      • PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 1627)
  • Kyivska Oblast
    • Kyiv, Kyivska Oblast, Ukraine, 01033
      • Limited Liability Company Medical center Healthy Happy ( Site 1625)
    • Kyiv, Kyivska Oblast, Ukraine, 02002
      • LLC "Adonis plus" ( Site 1619)
    • Kyiv, Kyivska Oblast, Ukraine, 03049
      • Kyiv railway clinical hospital 2 of Branch Health center ( Site 1602)
    • Kyiv, Kyivska Oblast, Ukraine, 04050
      • ARTEM. State Holding Company ( Site 1618)
  • Lvivska Oblast
    • Lviv, Lvivska Oblast, Ukraine, 79011
      • Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 1622)
  • Odeska Oblast
    • Odessa, Odeska Oblast, Ukraine, 65025
      • MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 1626)
  • Poltavska Oblast
    • Poltava, Poltavska Oblast, Ukraine, 36011
      • Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614)
  • Vinnytska Oblast
    • Vinnytsia, Vinnytska Oblast, Ukraine, 21009
      • Medical Center Health Clinic ( Site 1623)
• United Kingdom
  • Blackpool, United Kingdom, FY3 7EN
    • Layton Medical Centre ( Site 1705)
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704)
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2HX
      • The Adam Practice ( Site 1708)
  • Kent
    • Orpington, Kent, United Kingdom, BR5 3QG
      • Accellacare South London Quality Research Centre ( Site 1709)
  • London, City Of
    • London, London, City Of, United Kingdom, NW3 2QG
      • Royal Free London NHS Foundation Trust ( Site 1700)
    • London, London, City Of, United Kingdom, SE5 9RS
      • King's College Hospital ( Site 1707)
• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Phoenix Medical Group ( Site 1822)
  • California
    • Los Angeles, California, United States, 90036
      • Ruane Clinical Research Group, Inc. ( Site 2406)
    • Los Angeles, California, United States, 90069
      • Men's Health Foundation ( Site 1820)
    • North Hollywood, California, United States, 91606
      • Carbon Health Technologies Inc ( Site 2505)
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center ( Site 1833)
  • District of Columbia
    • Washington, District of Columbia, United States, 20011
      • Emerson Clinical Research Institute ( Site 1828)
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute ( Site 2508)
    • Fort Pierce, Florida, United States, 34982
      • Midway Immunology and Research Center ( Site 1837)
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc ( Site 1809)
    • Immokalee, Florida, United States, 34142
      • Advanced Research For Health Improvement LLC ( Site 1816)
    • Miami, Florida, United States, 33174
      • Advanced Medical Research, LLC ( Site 1864)
    • Naples, Florida, United States, 34102
      • Advanced Research For Health Improvement LLC ( Site 1813)
    • Orlando, Florida, United States, 32806
      • Bliss Healthcare Services ( Site 1847)
  • Georgia
    • Albany, Georgia, United States, 31707
      • Javara Inc. ( Site 1869)
    • Columbus, Georgia, United States, 31904
      • IACT Health ( Site 1818)
    • Fayetteville, Georgia, United States, 30214
      • Javara Inc. ( Site 1868)
  • Illinois
    • Chicago, Illinois, United States, 60644
      • Loretto Hospital ( Site 1886)
  • Maryland
    • Laurel, Maryland, United States, 20708
      • Jadestone Clinical Research, LLC ( Site 2502)
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Center of Medical Research ( Site 2500)
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center ( Site 2414)
  • New Jersey
    • Raritan, New Jersey, United States, 08869
      • Amici Clinical Research LLC ( Site 2507)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico, Health Sciences Center ( Site 1819)
    • Santa Fe, New Mexico, United States, 87505
      • AXCES Research Group ( Site 2418)
  • Texas
    • Bellaire, Texas, United States, 77401
      • Saint Hope Foundation, Inc. ( Site 1830)
    • Houston, Texas, United States, 77098
      • The Crofoot Research Center, Inc. ( Site 1812)
    • Sugar Land, Texas, United States, 77478
      • Javara Inc. ( Site 1866)
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners, LLC. ( Site 2503)
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center First Hill ( Site 1807)
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center ( Site 1829)
    • Spokane, Washington, United States, 99204
      • Multicare Health System ( Site 1811)
    • University Place, Washington, United States, 98466
      • Multicare Health System ( Site 1814)
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College Of Wisconsin ( Site 2510)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Molnupiravir 200 mg; 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir; Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total); Other Names: MK-4482
Experimental: Part 1: Molnupiravir 400 mg; 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir; Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total); Other Names: MK-4482
Experimental: Part 1: Molnupiravir 800 mg; 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir; Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total); Other Names: MK-4482
Placebo Comparator: Part 1: Placebo; Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Placebo; Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Placebo Comparator: Part 2: Placebo; Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total)	Drug: Placebo; Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
Experimental: Part 2: Molnupiravir 800 mg; 800 mg Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total)	Drug: Molnupiravir; Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total); Other Names: MK-4482

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Up to 29 days
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.	Day 3
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.	EOT (Day 5)
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.	Day 10
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.	Day 15
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.	Day 29

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.
• 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.
• 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, for the MOVe-OUT Study Group. Phase 2/3 Trial of Molnupiravir for Treatment of Covid-19 in Nonhospitalized Adults.NEJM Evid 2021;1(2). DOI: 10.1056/EVIDoa2100043. Published December 16, 2021. https://evidence.nejm.org/doi/full/10.1056/EVIDoa2100043

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): May 5, 2022

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Molnupiravir
• Other Study ID Numbers: 4482-002; MK-4482-002 (Other Identifier: Merck); PHRR201209-003186 (Registry Identifier: PHRR); jRCT2031210148 (Registry Identifier: jRCT); 2020-003368-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No