A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)

NCT06667700 | Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 4482-0232023-507227-36-00U1111-1295-4678MK-4482-023jRCT2031250022
• Study Type: interventional
• Target: 3,082
• Locations: 24 countries
• Sites: 222

Brief Summary

Researchers are looking for other ways to prevent severe illness from COVID-19. COVID-19 is a virus that most often causes mild flu or cold-like symptoms. However, people with certain health conditions or other factors have a high risk (chance) of getting severely ill from COVID-19, which can require a hospital stay or lead to death. Some people who are high risk for severe illness may be unable to take certain treatments for COVID-19 because they are not available to them, or they take other medicines that may react with a treatment and cause an unwanted effect. Molnupiravir (MK-4482) is a study medicine designed to stop the COVID-19 virus from copying itself in the body (multiplying). The goal of this study is to learn if molnupiravir prevents severe illness from COVID-19 more than placebo in people who are high risk.

Conditions

Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization, All-cause Mortality, or Covid-19-related Medically-attended Visit (MAV)

  Hospitalization is defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. Hospitalization and death may be due to any cause. An MAV is defined as any unscheduled, nonroutine healthcare visit where the participant is evaluated by a licensed (according to local/national guidelines) healthcare provider. As prespecified by the protocol, the percentage of participants who experience ONE OR MORE of these 3 events (hospitalization, death, or COVID-19-related MAV) occurring from randomization through Day 29 will be presented.

  Up to 29 days

• Percentage of Participants Who Experienced an Adverse Event (AE)

  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. The percentage of participants with at least 1 AE will be presented.

  Up to approximately 5 months

• Percentage of Participants Who Discontinued Study Intervention Due to AE

  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. The percentage of participants who discontinue study intervention due to an AE will be presented.

  Up to approximately 5 days

Secondary Outcomes (7)

• Time to Sustained Alleviation (without relapse) of all selected 8 (5 prespecified and 3 determined by baseline prevalence), self-reported COVID-19 signs/symptoms

  Up to 29 days

• Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Titer

  Day 1 (baseline) and up to Day 29

• Percentage of Participants with Undetectable SARS-CoV-2 RNA

  Up to 29 days

• Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization or All-cause Mortality

  Up to 29 days

• Percentage of Participants With Clinically Important Medical Interventions (CIMI) Associated with COVID-19-related MAV or COVID-19-related Hospitalization Through Day 29

  Up to 29 days

Study Arms (2)

Molnupiravir

EXPERIMENTAL

Participants will receive 800 mg molnupiravir orally every 12 hours for 5 days (a total of 10 consecutive doses)

Drug: Molnupiravir

Placebo

PLACEBO COMPARATOR

Participants will receive molnupiravir-matching placebo orally every 12 hours for 5 days (a total of 10 consecutive doses)

Drug: Placebo

Interventions

Molnupiravir DRUG

Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Also known as: MK-4482, LAGEVRIO®

Molnupiravir

Placebo DRUG

Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Placebo

Eligibility Criteria

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

You may qualify if:

• Is an individual of any sex/gender, ≥18 years of age
• Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization
• Has initial onset of signs/symptoms attributable to COVID-19 for ≤4 days prior to the day of randomization and ≥2 of the following signs/symptoms attributable to COVID-19 on the day of randomization: cough, sore throat, nasal congestion, shortness of breath or difficulty breathing with exertion, muscle or body aches, fatigue, fever \>38.0°C or chills, nausea or vomiting or diarrhea, change in sense of smell or change in sense of taste, or headache
• Has ≥1 of the following characteristics or medical conditions associated with the highest risk of severe illness from COVID-19:
• Advanced age of ≥75 years of age
• Immunocompromised
• Neurocognitive or physical disability
• Has ≥3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g., chronic lung disease, obesity with body mass index (BMI) ≥35, diabetes)
• Is unable or unwilling to receive treatment with nirmatrelvir/ritonavir (NMV/r) due to 1 or more of the following:
• Is receiving drug(s) highly dependent on cytochrome P450 3A (CYP3A) for clearance and for which elevated concentrations are associated with serious and/or life-threatening consequences or drug(s) with a clinically significant drug-drug interaction for which co-administration is not possible
• Is receiving potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance
• Has severe hepatic impairment
• Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use
• Has known or suspected NMV/r resistance
• Has uncontrolled HIV infection

You may not qualify if:

• Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently
• Has received or plans to receive SARS-CoV-2 directed oral antivirals or monoclonal antibodies for current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as standard of care)
• Has ≥1 of the following signs/symptoms that are attributable to severe or critical COVID-19:
• Shortness of breath at rest
• Respiratory rate ≥30 breaths per minute
• Heart rate ≥125 beats per minute
• Peripheral oxygen saturation (SpO2) ≤93% on room air or on supplemental oxygen for a reason other than COVID-19 which has not increased since onset of COVID-19 signs/symptoms
• New or increasing need for supplemental oxygen: receiving \>4 liters/minute supplemental oxygen due to COVID-19 OR on supplemental oxygen for a reason other than COVID-19 which has increased due to COVID-19
• Has received a COVID-19 vaccine within 30 days prior to randomization
• Has a history of confirmed influenza, respiratory syncytial virus (RSV), or SARS-CoV-2 infection (with or without symptoms; excluding current infection) within 30 days prior to randomization
• Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (222)

Cullman Clinical Trials ( Site 3813)

Cullman, Alabama, 35055, United States

COMPLETED

Helios Clinical Research ( Site 3826)

Paradise Valley, Arizona, 85253, United States

RECRUITING

Absolute Clinical Research ( Site 3709)

Phoenix, Arizona, 85051, United States

RECRUITING

Clinica de Salud del Valle de Salinas ( Site 3825)

Castroville, California, 95012, United States

RECRUITING

Ascada Health PC dba Ascada Research ( Site 3750)

Fullerton, California, 92835, United States

COMPLETED

Pacific Clinical Studies ( Site 3827)

Los Alamitos, California, 90720, United States

RECRUITING

Valley Clinical Trials, Inc. ( Site 3707)

Northridge, California, 91325, United States

RECRUITING

FOMAT Medical Research ( Site 3720)

Oxnard, California, 93030, United States

RECRUITING

Paradigm Clinical Research, LLC ( Site 3785)

San Diego, California, 91208, United States

RECRUITING

Optimus Medical ( Site 3817)

San Francisco, California, 94102, United States

RECRUITING

Millennium Clinical Trials ( Site 3758)

Westlake Village, California, 91361, United States

RECRUITING

Paradigm Clinical Research Centers, Inc ( Site 3718)

Wheat Ridge, Colorado, 80033, United States

RECRUITING

Encore Medical Research of Boynton Beach ( Site 3701)

Boynton Beach, Florida, 33436, United States

RECRUITING

Prestige Clinical Research Center ( Site 3722)

Coral Gables, Florida, 33134, United States

RECRUITING

Indago Research & Health Center, Inc ( Site 3714)

Hialeah, Florida, 33012, United States

RECRUITING

Prestige Clinical Research ( Site 3830)

Homestead, Florida, 33030, United States

RECRUITING

Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779)

Largo, Florida, 33777, United States

RECRUITING

Clinical Site Partners, LLC dba Flourish Research ( Site 3717)

Leesburg, Florida, 34748, United States

RECRUITING

Advanced Pulmonary Research Institute ( Site 3781)

Loxahatchee Groves, Florida, 33470, United States

RECRUITING

Southern Clinical Research ( Site 3773)

Miami, Florida, 33125, United States

RECRUITING

Florida Pharmaceutical Research and Associates ( Site 3763)

Miami, Florida, 33143, United States

RECRUITING

Bio-Medical Research LLC ( Site 3804)

Miami, Florida, 33144, United States

RECRUITING

Bright Research Center ( Site 3746)

Miami, Florida, 33144, United States

COMPLETED

Miami Clinical Research ( Site 3729)

Miami, Florida, 33155, United States

RECRUITING

Reed Medical Research ( Site 3761)

Miami, Florida, 33176, United States

RECRUITING

Palm Springs Community Health Center ( Site 3757)

Miami Lakes, Florida, 33014, United States

RECRUITING

Panax Clinical Research ( Site 3803)

Miami Lakes, Florida, 33014, United States

RECRUITING

Combined Research Orlando Phase I-IV ( Site 3797)

Orlando, Florida, 32807, United States

RECRUITING

CDC Research Institute ( Site 3716)

Port Saint Lucie, Florida, 34952, United States

RECRUITING

New Tampa Health ( Site 3764)

Tampa, Florida, 33603, United States

RECRUITING

Clinical Research Trials of Florida ( Site 3703)

Tampa, Florida, 33607, United States

RECRUITING

Precision Research Center ( Site 3704)

Tampa, Florida, 33614, United States

RECRUITING

Encore Medical Research - Weston ( Site 3708)

Weston, Florida, 33331, United States

ACTIVE NOT RECRUITING

Balanced Life Health Care Solutions/SKYCRNG ( Site 3713)

Lawrenceville, Georgia, 30046, United States

RECRUITING

Renew Health Clinical Research ( Site 3760)

Snellville, Georgia, 30078, United States

RECRUITING

Rophe Adult and Pediatric Medicine/SKYCRNG ( Site 3816)

Union City, Georgia, 30291, United States

COMPLETED

Paradigm Clinical Research - Boise ( Site 3841)

Boise, Idaho, 83709, United States

RECRUITING

Rush University Medical Center ( Site 3748)

Chicago, Illinois, 60612, United States

RECRUITING

Duly Health and Care ( Site 3799)

Lombard, Illinois, 60148, United States

RECRUITING

University of Louisville School of Medicine ( Site 3706)

Louisville, Kentucky, 40202, United States

RECRUITING

Barnum Medical Research ( Site 3828)

Natchitoches, Louisiana, 71457, United States

COMPLETED

Annapolis Internal Medicine - CCT Research ( Site 3700)

Annapolis, Maryland, 21401, United States

RECRUITING

Kur Research - Columbia Medical ( Site 3767)

Columbia, Maryland, 21045, United States

RECRUITING

Revival Research Institute, LLC ( Site 3835)

Dearborn, Michigan, 48126, United States

COMPLETED

Michigan Center of Medical Research (MICHMER) ( Site 3734)

Farmington Hills, Michigan, 48334, United States

RECRUITING

Henry Ford St John TM Center for Infectious Disease Research ( Site 3766)

Grosse Pointe Woods, Michigan, 48236, United States

RECRUITING

Mankato Clinic ( Site 3842)

Mankato, Minnesota, 56001, United States

RECRUITING

Prime Health and Wellness/SKYCRNG ( Site 3726)

Fayette, Mississippi, 39069, United States

RECRUITING

SKY Integrative Medical Center/SKYCRNG ( Site 3740)

Ridgeland, Mississippi, 39157, United States

RECRUITING

Nevada Health Centers ( Site 3840)

Carson City, Nevada, 89706, United States

RECRUITING

WR-CRCN, LLC ( Site 3818)

Las Vegas, Nevada, 89106, United States

RECRUITING

Saint Michael's Medical Center ( Site 3808)

Newark, New Jersey, 07102, United States

RECRUITING

Holy Name Medical Center ( Site 3807)

Teaneck, New Jersey, 07666, United States

RECRUITING

Weill Cornell Medical College ( Site 3814)

New York, New York, 10065, United States

RECRUITING

Prime Global Research ( Site 3731)

The Bronx, New York, 10456, United States

RECRUITING

OnSite Clinical Solutions ( Site 3784)

Charlotte, North Carolina, 28277, United States

RECRUITING

Monroe Biomedical Research ( Site 3732)

Monroe, North Carolina, 28112, United States

RECRUITING

IMA Clinical Research Mount Airy ( Site 3745)

Mount Airy, North Carolina, 27030, United States

RECRUITING

Research Innovations, LLC ( Site 3712)

Beavercreek, Ohio, 45431, United States

RECRUITING

Midlands Neurology & Pain Associates ( Site 3751)

Columbia, South Carolina, 29205, United States

ACTIVE NOT RECRUITING

Helios Clinical Research - JAC ( Site 3833)

Jackson, Tennessee, 38305, United States

RECRUITING

Javara - Privia Medical Group Gulf Coast - The Woodlands HWH ( Site 3837)

Conroe, Texas, 77384, United States

RECRUITING

South Texas Clinical Research ( Site 3815)

Corpus Christi, Texas, 78404, United States

RECRUITING

Care United Research, LLC ( Site 3747)

Forney, Texas, 75126, United States

RECRUITING

Houston Methodist Hospital ( Site 3800)

Houston, Texas, 77030, United States

RECRUITING

MD Anderson ( Site 3843)

Houston, Texas, 77030, United States

RECRUITING

Andres Garcia Zuniga, M.D., P.A. ( Site 3782)

Laredo, Texas, 78041, United States

RECRUITING

LinQ Research ( Site 3824)

Pearland, Texas, 77584, United States

RECRUITING

Crossroads Clinical Research-Family Practice ( Site 3739)

Victoria, Texas, 77901, United States

RECRUITING

Velocity Clinical Research - Hampton ( Site 3744)

Hampton, Virginia, 23666, United States

RECRUITING

Eastside Research Associates ( Site 3727)

Redmond, Washington, 98052, United States

RECRUITING

CEMIC ( Site 0101)

Buenos Aires., Buenos Aires, C1431FWO, Argentina

RECRUITING

Hospital Italiano de Buenos Aires ( Site 0107)

Ciudad Autonoma de Buenos Aires., Buenos Aires, C1199ABB, Argentina

RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0111)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Nefra Medical Care - Moron ( Site 0109)

Morón, Buenos Aires, 1708, Argentina

RECRUITING

Hospital Felicio Rocho (HFR) - Nucleo de Ciencias da Saude ( Site 0402)

Belo Horizonte, Minas Gerais, 30180-080, Brazil

RECRUITING

Instituto Atena de Pesquisa Clinica ( Site 0406)

Natal, Rio Grande do Norte, 59020-500, Brazil

RECRUITING

Centro de Pesquisa em Medicina Tropical - CEPEM - Rondonia ( Site 0405)

Porto Velho, Rondônia, 76812329, Brazil

RECRUITING

Centro de Pesquisa Sao Lucas ( Site 0401)

Campinas, São Paulo, 13060-803, Brazil

RECRUITING

Centro de Pesquisa Clinica Institucional do HCFMUSP - CPCi ( Site 0403)

São Paulo, 05403-010, Brazil

RECRUITING

Medical Center Asclepius ( Site 0506)

Velingrad, Pazardzhik, 4600, Bulgaria

RECRUITING

Medical Center Zdrave 1 ( Site 0509)

Kozloduy, Vratsa, 3320, Bulgaria

RECRUITING

Medconsult Pleven - Lovech ( Site 0501)

Lovech, 5500, Bulgaria

RECRUITING

Medical Center Hera ( Site 0507)

Montana, 3400, Bulgaria

RECRUITING

MHAT "Dr. Stamen Iliev" Montana-Department of Pulmonology ( Site 0504)

Montana, 3403, Bulgaria

RECRUITING

Medconsult Pleven ( Site 0503)

Pleven, 5800, Bulgaria

RECRUITING

DKC V - Plovdiv ( Site 0508)

Plovdiv, 4023, Bulgaria

RECRUITING

SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD ( Site 0502)

Rousse, 7002, Bulgaria

RECRUITING

Diagnostic Consultative Center 22 - Sofia ( Site 0500)

Sofia, 1113, Bulgaria

RECRUITING

Medical Center Hera EOOD ( Site 0505)

Sofia, 1510, Bulgaria

RECRUITING

IPS SURA San Diego ( Site 0806)

Medellín, Antioquia, 50016, Colombia

RECRUITING

IPS Centro Científico Asistencial S.A.S ( Site 0800)

Barranquilla, Atlántico, 080020, Colombia

RECRUITING

Clinica Colsanitas - Sede Reina Sofia ( Site 0807)

Bogotá, Bogota D.C., 110111, Colombia

RECRUITING

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0804)

Bogotá, Bogota D.C., 111321, Colombia

RECRUITING

Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0801)

Valledupar, Cesar Department, 200001, Colombia

RECRUITING

IMAT S.A.S ( Site 0805)

Montería, Departamento de Córdoba, 230002, Colombia

RECRUITING

Fundación Valle del Lili ( Site 0803)

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

MeVac - Meilahti Vaccine Research Center ( Site 1200)

Helsinki, Uusimaa, 00290, Finland

RECRUITING

Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital F-Centre d'Investigation Clinique - Plur ( Site 1301)

Dijon, Bourgogne-Franche-Comté, 21000, France

RECRUITING

CHU de Saint-Etienne ( Site 1302)

Saint Priest En Jarez, Pays de la Loire Region, 42270, France

RECRUITING

centre hospitalier lyon sud ( Site 1303)

Pierre-Bénite, Rhone, 69310, France

RECRUITING

Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1300)

Paris, Île-de-France Region, 75013, France

RECRUITING

Clinic Health - Batumi ( Site 1405)

Batumi, Adjara, 6000, Georgia

RECRUITING

Family Medical Regional Center ( Site 1404)

Batumi, Adjara, 6000, Georgia

RECRUITING

LTD High Technology Hospital Medcenter ( Site 1408)

Batumi, Adjara, 6010, Georgia

RECRUITING

University Clinic of Innovative Medicine ( Site 1400)

Batumi, Adjara, 6010, Georgia

RECRUITING

Caucasus Medical Centre ( Site 1406)

Tbilisi, Adjara, 0186, Georgia

RECRUITING

"Georgian Clinics" JSC ( Site 1410)

Zugdidi, Samegrelo and Zemo Svaneti, 2100, Georgia

RECRUITING

New Hospitals ( Site 1409)

Tbilisi, 0114, Georgia

RECRUITING

Curatio Clinic - Main Location ( Site 1401)

Tbilisi, 0186, Georgia

RECRUITING

TUM Klinikum ( Site 1502)

Munich, Bavaria, 81675, Germany

RECRUITING

Universitätsklinikum Frankfurt Goethe-Universität ( Site 1503)

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Universitaetsklinikum Koeln ( Site 1505)

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Campus Charite Mitte Nephrologie und Internistische Intensivmedizin ( Site 1501)

Berlin, State of Berlin, 10117, Germany

ACTIVE NOT RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1904)

Bologna, 40138, Italy

RECRUITING

Ospedale San Martino ( Site 1900)

Genova, 16132, Italy

RECRUITING

ASST Fatebenefratelli Sacco ( Site 1901)

Milan, 20157, Italy

RECRUITING

AOU Pisana- Ospedale Cisanello ( Site 1905)

Pisa, 56124, Italy

RECRUITING

National Hospital Organization Shimoshizu National Hospital ( Site 2007)

Yotsukaidō, Chiba, 284-0003, Japan

RECRUITING

Tsuchiura Beryl Clinic ( Site 2009)

Tsuchiura, Ibaraki, 300-0062, Japan

RECRUITING

National Hospital Organization Tokyo National Hospital ( Site 2003)

Kiyose, Tokyo, 204-8585, Japan

RECRUITING

Sekino Hospital ( Site 2016)

Toshimaku, Tokyo, 171-0014, Japan

RECRUITING

National Hospital Organization Kyushu Medical Center ( Site 2006)

Fukuoka, 810-8563, Japan

RECRUITING

Kumamoto Chuo Hospital ( Site 2002)

Kumamoto, 862-0965, Japan

RECRUITING

Morales Vargas Centro de Investigacion ( Site 2206)

León, Guanajuato, 37000, Mexico

RECRUITING

CIO - Centro de Inmuno-Oncología de Occidente ( Site 2207)

Guadalajara, Jalisco, 44630, Mexico

RECRUITING

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Departamento de Infectología ( Site 2203)

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Instituto Nacional de Salud Publica ( Site 2205)

Cuernavaca, Morelos, 62100, Mexico

RECRUITING

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2204)

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 2202)

Mérida, Yucatán, 97130, Mexico

RECRUITING

ICARO Investigaciones en Medicina ( Site 2200)

Chihuahua City, 31000, Mexico

RECRUITING

Arké SMO S.A de C.V-ARKE SMO S.A. de C.V. ( Site 2210)

Veracruz, 91910, Mexico

RECRUITING

CGM Research Trust ( Site 2307)

Christchurch, Canterbury, 8013, New Zealand

RECRUITING

Pacific Clinical Research Network - Tasman ( Site 2304)

Nelson, Tasman District, 7011, New Zealand

RECRUITING

Lakeland Clinical Trials Waikato ( Site 2302)

Nawton, Waikato Region, 3200, New Zealand

RECRUITING

Lakeland Clinical Trials Wellington ( Site 2303)

Upper Hutt, Wellington Region, 5018, New Zealand

RECRUITING

Pacific Clinical Research Network West Auckland ( Site 2301)

Auckland, 0600, New Zealand

RECRUITING

Optimal Clinical Trials North ( Site 2308)

Auckland, 0632, New Zealand

RECRUITING

Silverdale Medical Limited ( Site 2305)

Auckland, 0932, New Zealand

RECRUITING

Optimal Clinical Trials ( Site 2306)

Auckland, 1010, New Zealand

RECRUITING

Asociación Civil Selva Amazónica ( Site 2405)

Iquitos, Loreto, 16001, Peru

RECRUITING

Via Libre ( Site 2409)

Lima, 15001, Peru

RECRUITING

Clinica Ricardo Palma-Centro de Investigacion de Enfermedades Respiratorias Thorax ( Site 2404)

Lima, 15036, Peru

RECRUITING

Health Index Multispeciality Clinic ( Site 2501)

Bacoor, Cavite, 4102, Philippines

RECRUITING

Ospital Ng Makati ( Site 2505)

Makati City, National Capital Region, 1218, Philippines

RECRUITING

Philippine General Hospital-Department of Medicine ( Site 2504)

Manila, National Capital Region, 1000, Philippines

RECRUITING

GreenCity Medical Center ( Site 2503)

San Fernando City, Pampanga, 2000, Philippines

RECRUITING

PL Certus ( Site 2613)

Poznan, Greater Poland Voivodeship, 60-309, Poland

RECRUITING

In-Vivo Bydgoszcz ( Site 2601)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

RECRUITING

NZOZ GynCentrum - Oddział Kraków ( Site 2609)

Krakow, Lesser Poland Voivodeship, 31-322, Poland

RECRUITING

Penta Hospitals Przychodnie Wrocław Wejherowska ( Site 2611)

Wroclaw, Lower Silesian Voivodeship, 54-239, Poland

RECRUITING

NZOZ GynCentrum - Oddział Bielsko-Biała ( Site 2602)

Bielsko-Biala, Silesian Voivodeship, 43-300, Poland

RECRUITING

Clinical Medical Research ( Site 2604)

Katowice, Silesian Voivodeship, 40-156, Poland

RECRUITING

Holsamed ( Site 2603)

Katowice, Silesian Voivodeship, 40-600, Poland

RECRUITING

Investigadores del Este LLC ( Site 4001)

Humacao, 00791, Puerto Rico

RECRUITING

Miralles Clinical Research LLC ( Site 4004)

San Juan, 00921, Puerto Rico

RECRUITING

MV HEALTH SERVICES LLC ( Site 4003)

San Juan, 00926, Puerto Rico

RECRUITING

Spitalul Clinic de Boli Infecțioase și Tropicale Victor Babeș ( Site 2701)

Bucharest, Bucharest, 030303, Romania

RECRUITING

Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu ( Site 2705)

Baloteşti, Ilfov, 077015, Romania

COMPLETED

Centrul Medical SANA ( Site 2704)

Bucharest, 011025, Romania

RECRUITING

National Institute for Infectious Diseases Prof. Dr. Matei Bals ( Site 2706)

Bucharest, 021105, Romania

RECRUITING

National Institute for Infectious Diseases Prof. Dr. Matei Bals ( Site 2707)

Bucharest, 021105, Romania

RECRUITING

Spitalul Clinic de Boli Infecțioase ( Site 2703)

Cluj-Napoca, 400348, Romania

RECRUITING

Spitalul Clinic de Boli Infecțioase ( Site 2702)

Constanța, 900709, Romania

RECRUITING

Wonju Severance Christian Hospital-Internal Medicine ( Site 3009)

Wŏnju, Kang-won-do, 26426, South Korea

RECRUITING

Chonnam National University Hospital-Infectious Diseases ( Site 3008)

Gwangju, Kwangju-Kwangyokshi, 61469, South Korea

RECRUITING

Korea University Ansan Hospital ( Site 3007)

Ansan-si, Kyonggi-do, 15355, South Korea

RECRUITING

Gyeongsang National University Hospital ( Site 3005)

Jinju, Kyongsangnam-do, 52727, South Korea

RECRUITING

Pusan National University Hospital-Internal Medicine ( Site 3010)

Pusan, Pusan-Kwangyokshi, 49241, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3002)

Deagu, Taegu-Kwangyokshi, 41404, South Korea

RECRUITING

Korea University Anam Hospital ( Site 3001)

Seoul, 02841, South Korea

RECRUITING

Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3003)

Seoul, 07441, South Korea

RECRUITING

Korea University Guro Hospital ( Site 3006)

Seoul, 08308, South Korea

RECRUITING

Hospital General Universitario de Elche-Infectius Disease ( Site 3105)

Elche, Alicante, 03202, Spain

RECRUITING

Hospital Germans Trias i Pujol ( Site 3101)

Badalona, Barcelona, 08916, Spain

RECRUITING

EAP Osona Sud - Alt Congost S.L.P ( Site 3107)

Centelles, Barcelona, 08540, Spain

RECRUITING

Hospital Universitari Vall d'Hebron ( Site 3102)

Barcelona, Catalonia, 08035, Spain

RECRUITING

Hospital Universitario de A Coruña ( Site 3112)

A Coruña, Galicia, 15006, Spain

RECRUITING

Hospital Santa Lucia-Medicina Infecciosas ( Site 3106)

Cartagena, Murcia, 30202, Spain

RECRUITING

EAP Sardenya ( Site 3109)

Barcelona, 08025, Spain

RECRUITING

Hospital Universitario Infanta Leonor ( Site 3110)

Madrid, 28031, Spain

RECRUITING

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 3100)

Seville, 41013, Spain

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3306)

Kaoshiung, Kaohsiung, 807, Taiwan

RECRUITING

Taoyuan General Hospital ( Site 3300)

Taoyuan, Taoyuan, 33004, Taiwan

RECRUITING

Kaohsiung Veterans General Hospital ( Site 3307)

Kaohsiung City, 813, Taiwan

RECRUITING

Taipei Medical University - Shuang Ho Hospital ( Site 3308)

New Taipei City, 23561, Taiwan

RECRUITING

Taichung Veterans General Hospital ( Site 3305)

Taichung, 40705, Taiwan

RECRUITING

National Taiwan University Hospital ( Site 3301)

Taipei, 10002, Taiwan

RECRUITING

Tri-Service General Hospital ( Site 3304)

Taipei, 114, Taiwan

RECRUITING

Taipei Municipal Wangfang Hospital ( Site 3309)

Taipei, 11696, Taiwan

RECRUITING

Chang Gung Memorial Hospital - Linkou Branch ( Site 3303)

Taoyuan District, 333, Taiwan

RECRUITING

Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 3401)

Bangkok, Bangkok, 10700, Thailand

RECRUITING

HIV Netherlands Australia Thailand Research Collaboration ( Site 3402)

Pathumwan, Bangkok, 10330, Thailand

RECRUITING

EUROMEDCLINIC ( Site 3517)

Cherkasy, Cherkasy Oblast, 18021, Ukraine

RECRUITING

MUNICIPAL NON-PROFIT ENTERPRISE CENTRAL CITY CLINICAL HOSPITAL OF CHERNIVTSI CITY COUNCIL ( Site 3513)

Chernivtsi, Chernihiv Oblast, 58022, Ukraine

RECRUITING

Clinical medical and diagnostic center Limited Liability Company "Simedgroup" ( Site 3524)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine

RECRUITING

Regional Phthisiology and Pulmonology Center ( Site 3523)

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

RECRUITING

Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 3537)

Kropyvnytskyi, Kirovohrad Oblast, 25006, Ukraine

RECRUITING

Limited Liability Company Ukrainian Center of Tomotherapy-Clinical Trials Department ( Site 3512)

Kropyvnytskyi, Kirovohrad Oblast, 25011, Ukraine

RECRUITING

Medical Center "Harmoniya Krasy" ( Site 3545)

Kyiv, Kyivska Oblast, 01135, Ukraine

RECRUITING

Edelweiss Medics ( Site 3503)

Kyiv, Kyivska Oblast, 02002, Ukraine

RECRUITING

Communal Non-Profit Enterprise "Kyiv City Clinical Hospital #1"-Department of Clinical Research ( Site 3514)

Kyiv, Kyivska Oblast, 02091, Ukraine

RECRUITING

Medbud Clinic-Treatment prevention unit ( Site 3506)

Kyiv, Kyivska Oblast, 03037, Ukraine

RECRUITING

Medical Center of Limited ( Site 3546)

Kyiv, Kyivska Oblast, 04050, Ukraine

RECRUITING

Center of Family Medicine Plus ( Site 3502)

Kyiv, Kyivska Oblast, 04210, Ukraine

RECRUITING

Polyclinic of Communal 4th city clinical hospital ( Site 3501)

Lviv, Lviv Oblast, 79011, Ukraine

RECRUITING

Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 3525)

Lviv, Lviv Oblast, 79059, Ukraine

RECRUITING

University clinic of the National Pirogov Memorial Medical University ( Site 3547)

Vinnytsia, Vinnytsia Oblast, 21001, Ukraine

RECRUITING

Clinic of Pyrohov National Medical University of Vinnytsia ( Site 3528)

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

RECRUITING

Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 3530)

Lutsk, Volyn Oblast, 43005, Ukraine

RECRUITING

Uzhhorod Municipal Multidisciplinary Clinical Hospital of Uzhhorod City Council ( Site 3538)

Uzhhorod, Zakarpattia Oblast, 88000, Ukraine

RECRUITING

Medlight Clinic ( Site 3548)

Kyiv, 02222, Ukraine

RECRUITING

Kyiv Railway Clinical Hospital No.2 of Branch Health Center -Center of Clinical Trials ( Site 3549)

Kyiv, 03049, Ukraine

RECRUITING

Whiteladies Medical Group ( Site 3611)

Bristol, Bristol, City of, BS8 2PU, United Kingdom

RECRUITING

Royal Devon & Exeter Hospital ( Site 3604)

Exeter, England, EX2 5DW, United Kingdom

RECRUITING

Royal Victoria Infirmary ( Site 3608)

Newcastle, Newcastle Upon Tyne, NE1 4LP, United Kingdom

RECRUITING

Norwich Practices Health Centre ( Site 3605)

Norwich, Norfolk, NR1 1RB, United Kingdom

RECRUITING

Oak Street Medical Practice ( Site 3612)

Norwich, Norfolk, NR3 3DL, United Kingdom

RECRUITING

Lakeside Surgery ( Site 3600)

Northamptonshire, Northamptonshire, NN17 2UR, United Kingdom

RECRUITING

Bicester Health Centre ( Site 3609)

Bicester, Oxfordshire, OX26 6AT, United Kingdom

RECRUITING

Banbury Cross Health Centre ( Site 3610)

Oxford, Oxfordshire, OX16 9AD, United Kingdom

RECRUITING

Buttercross Health Centre ( Site 3606)

Somerset, Somerset, TA11 7PB, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Protocol Plain Language Summary

MeSH Terms

Conditions

COVID-19

Interventions

molnupiravir

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): January 26, 2031
• Study Completion (Estimated): January 26, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

PR (3); ES (9); DE (4); BU (10); RO (7); KR (9); TW (9); PH (4); PE (3); PL (7); JP (6); FI (1); FR (4); GE (8); TH (2); US (71); UA (20); AR (4); BR (5); NZ (8); GB (9); ME (8); CO (7); IT (4)