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A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adults With COVID-19 at High Risk for Disease Progression
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3082
Start Date
2024-12-02
Completion Date
2031-01-26
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Molnupiravir
Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)
Placebo
Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)
Locations (218)
Cullman Clinical Trials ( Site 3813)
Cullman, Alabama, United States
Helios Clinical Research ( Site 3826)
Paradise Valley, Arizona, United States
Absolute Clinical Research ( Site 3709)
Phoenix, Arizona, United States
Clinica de Salud del Valle de Salinas ( Site 3825)
Castroville, California, United States
Ascada Health PC dba Ascada Research ( Site 3750)
Fullerton, California, United States
Pacific Clinical Studies ( Site 3827)
Los Alamitos, California, United States
Valley Clinical Trials, Inc. ( Site 3707)
Northridge, California, United States
FOMAT Medical Research ( Site 3720)
Oxnard, California, United States
Paradigm Clinical Research, LLC ( Site 3785)
San Diego, California, United States
Optimus Medical ( Site 3817)
San Francisco, California, United States
Millennium Clinical Trials ( Site 3758)
Westlake Village, California, United States
Paradigm Clinical Research Centers, Inc ( Site 3718)
Wheat Ridge, Colorado, United States
Encore Medical Research of Boynton Beach ( Site 3701)
Boynton Beach, Florida, United States
Prestige Clinical Research Center ( Site 3722)
Coral Gables, Florida, United States
Indago Research & Health Center, Inc ( Site 3714)
Hialeah, Florida, United States
Prestige Clinical Research ( Site 3830)
Homestead, Florida, United States
Accel Research Sites Network - St. Pete-Largo Clinical Research Unit ( Site 3779)
Largo, Florida, United States
Clinical Site Partners, LLC dba Flourish Research ( Site 3717)
Leesburg, Florida, United States
Advanced Pulmonary Research Institute ( Site 3781)
Loxahatchee Groves, Florida, United States
Southern Clinical Research ( Site 3773)
Miami, Florida, United States
Florida Pharmaceutical Research and Associates ( Site 3763)
Miami, Florida, United States
Bio-Medical Research LLC ( Site 3804)
Miami, Florida, United States
Bright Research Center ( Site 3746)
Miami, Florida, United States
Miami Clinical Research ( Site 3729)
Miami, Florida, United States
Reed Medical Research ( Site 3761)
Miami, Florida, United States
Palm Springs Community Health Center ( Site 3757)
Miami Lakes, Florida, United States
Panax Clinical Research ( Site 3803)
Miami Lakes, Florida, United States
Combined Research Orlando Phase I-IV ( Site 3797)
Orlando, Florida, United States
CDC Research Institute ( Site 3716)
Port Saint Lucie, Florida, United States
New Tampa Health ( Site 3764)
Tampa, Florida, United States
Clinical Research Trials of Florida ( Site 3703)
Tampa, Florida, United States
Precision Research Center ( Site 3704)
Tampa, Florida, United States
Encore Medical Research - Weston ( Site 3708)
Weston, Florida, United States
Balanced Life Health Care Solutions/SKYCRNG ( Site 3713)
Lawrenceville, Georgia, United States
Renew Health Clinical Research ( Site 3760)
Snellville, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG ( Site 3816)
Union City, Georgia, United States
Paradigm Clinical Research - Boise ( Site 3841)
Boise, Idaho, United States
Rush University Medical Center ( Site 3748)
Chicago, Illinois, United States
Duly Health and Care ( Site 3799)
Lombard, Illinois, United States
University of Louisville School of Medicine ( Site 3706)
Louisville, Kentucky, United States
Barnum Medical Research ( Site 3828)
Natchitoches, Louisiana, United States
Annapolis Internal Medicine - CCT Research ( Site 3700)
Annapolis, Maryland, United States
Kur Research - Columbia Medical ( Site 3767)
Columbia, Maryland, United States
Revival Research Institute, LLC ( Site 3835)
Dearborn, Michigan, United States
Michigan Center of Medical Research (MICHMER) ( Site 3734)
Farmington Hills, Michigan, United States
Henry Ford St John TM Center for Infectious Disease Research ( Site 3766)
Grosse Pointe Woods, Michigan, United States
Mankato Clinic ( Site 3842)
Mankato, Minnesota, United States
Prime Health and Wellness/SKYCRNG ( Site 3726)
Fayette, Mississippi, United States
SKY Integrative Medical Center/SKYCRNG ( Site 3740)
Ridgeland, Mississippi, United States
Nevada Health Centers ( Site 3840)
Carson City, Nevada, United States
WR-CRCN, LLC ( Site 3818)
Las Vegas, Nevada, United States
Saint Michael's Medical Center ( Site 3808)
Newark, New Jersey, United States
Holy Name Medical Center ( Site 3807)
Teaneck, New Jersey, United States
Weill Cornell Medical College ( Site 3814)
New York, New York, United States
Prime Global Research ( Site 3731)
The Bronx, New York, United States
OnSite Clinical Solutions ( Site 3784)
Charlotte, North Carolina, United States
Monroe Biomedical Research ( Site 3732)
Monroe, North Carolina, United States
IMA Clinical Research Mount Airy ( Site 3745)
Mount Airy, North Carolina, United States
Research Innovations, LLC ( Site 3712)
Beavercreek, Ohio, United States
Midlands Neurology & Pain Associates ( Site 3751)
Columbia, South Carolina, United States
Helios Clinical Research - JAC ( Site 3833)
Jackson, Tennessee, United States
Javara - Privia Medical Group Gulf Coast - The Woodlands HWH ( Site 3837)
Conroe, Texas, United States
South Texas Clinical Research ( Site 3815)
Corpus Christi, Texas, United States
Care United Research, LLC ( Site 3747)
Forney, Texas, United States
Houston Methodist Hospital ( Site 3800)
Houston, Texas, United States
MD Anderson ( Site 3843)
Houston, Texas, United States
Andres Garcia Zuniga, M.D., P.A. ( Site 3782)
Laredo, Texas, United States
LinQ Research ( Site 3824)
Pearland, Texas, United States
Crossroads Clinical Research-Family Practice ( Site 3739)
Victoria, Texas, United States
Velocity Clinical Research - Hampton ( Site 3744)
Hampton, Virginia, United States
Eastside Research Associates ( Site 3727)
Redmond, Washington, United States
CEMIC ( Site 0101)
Buenos Aires., Buenos Aires, Argentina
Hospital Italiano de Buenos Aires ( Site 0107)
Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0111)
Mar del Plata, Buenos Aires, Argentina
Nefra Medical Care - Moron ( Site 0109)
Morón, Buenos Aires, Argentina
Hospital Felicio Rocho (HFR) - Nucleo de Ciencias da Saude ( Site 0402)
Belo Horizonte, Minas Gerais, Brazil
Centro de Pesquisa Sao Lucas ( Site 0401)
Campinas, São Paulo, Brazil
Centro de Pesquisa Clinica Institucional do HCFMUSP - CPCi ( Site 0403)
São Paulo, Brazil
Medical Center Asclepius ( Site 0506)
Velingrad, Pazardzhik, Bulgaria
Medical Center Zdrave 1 ( Site 0509)
Kozloduy, Vratsa, Bulgaria
Medconsult Pleven - Lovech ( Site 0501)
Lovech, Bulgaria
Medical Center Hera ( Site 0507)
Montana, Bulgaria
MHAT "Dr. Stamen Iliev" Montana-Department of Pulmonology ( Site 0504)
Montana, Bulgaria
Medconsult Pleven ( Site 0503)
Pleven, Bulgaria
DKC V - Plovdiv ( Site 0508)
Plovdiv, Bulgaria
SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD ( Site 0502)
Rousse, Bulgaria
Diagnostic Consultative Center 22 - Sofia ( Site 0500)
Sofia, Bulgaria
Medical Center Hera EOOD ( Site 0505)
Sofia, Bulgaria
IPS SURA San Diego ( Site 0806)
Medellín, Antioquia, Colombia
IPS Centro Científico Asistencial S.A.S ( Site 0800)
Barranquilla, Atlántico, Colombia
Clinica Colsanitas - Sede Reina Sofia ( Site 0807)
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0804)
Bogotá, Bogota D.C., Colombia
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0801)
Valledupar, Cesar Department, Colombia
IMAT S.A.S ( Site 0805)
Montería, Departamento de Córdoba, Colombia
Fundación Valle del Lili ( Site 0803)
Cali, Valle del Cauca Department, Colombia
MeVac - Meilahti Vaccine Research Center ( Site 1200)
Helsinki, Uusimaa, Finland
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital F-Centre d'Investigation Clinique - Plur ( Site 1301)
Dijon, Bourgogne-Franche-Comté, France
CHU de Saint-Etienne ( Site 1302)
Saint Priest En Jarez, Pays de la Loire Region, France
centre hospitalier lyon sud ( Site 1303)
Pierre-Bénite, Rhone, France
Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1300)
Paris, Île-de-France Region, France
Clinic Health - Batumi ( Site 1405)
Batumi, Adjara, Georgia
Family Medical Regional Center ( Site 1404)
Batumi, Adjara, Georgia
LTD High Technology Hospital Medcenter ( Site 1408)
Batumi, Adjara, Georgia
University Clinic of Innovative Medicine ( Site 1400)
Batumi, Adjara, Georgia
Caucasus Medical Centre ( Site 1406)
Tbilisi, Adjara, Georgia
"Georgian Clinics" JSC ( Site 1410)
Zugdidi, Samegrelo and Zemo Svaneti, Georgia
New Hospitals ( Site 1409)
Tbilisi, Georgia
Curatio Clinic - Main Location ( Site 1401)
Tbilisi, Georgia
TUM Klinikum ( Site 1502)
Munich, Bavaria, Germany
Universitätsklinikum Frankfurt Goethe-Universität ( Site 1503)
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Koeln ( Site 1505)
Cologne, North Rhine-Westphalia, Germany
Campus Charite Mitte Nephrologie und Internistische Intensivmedizin ( Site 1501)
Berlin, State of Berlin, Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1904)
Bologna, Italy
Ospedale San Martino ( Site 1900)
Genova, Italy
ASST Fatebenefratelli Sacco ( Site 1901)
Milan, Italy
AOU Pisana- Ospedale Cisanello ( Site 1905)
Pisa, Italy
National Hospital Organization Shimoshizu National Hospital ( Site 2007)
Yotsukaidō, Chiba, Japan
Tsuchiura Beryl Clinic ( Site 2009)
Tsuchiura, Ibaraki, Japan
National Hospital Organization Tokyo National Hospital ( Site 2003)
Kiyose, Tokyo, Japan
Sekino Hospital ( Site 2016)
Toshimaku, Tokyo, Japan
National Hospital Organization Kyushu Medical Center ( Site 2006)
Fukuoka, Japan
Kumamoto Chuo Hospital ( Site 2002)
Kumamoto, Japan
Morales Vargas Centro de Investigacion ( Site 2206)
León, Guanajuato, Mexico
CIO - Centro de Inmuno-Oncología de Occidente ( Site 2207)
Guadalajara, Jalisco, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Departamento de Infectología ( Site 2203)
Mexico City, Mexico City, Mexico
Instituto Nacional de Salud Publica ( Site 2205)
Cuernavaca, Morelos, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2204)
Monterrey, Nuevo León, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 2202)
Mérida, Yucatán, Mexico
ICARO Investigaciones en Medicina ( Site 2200)
Chihuahua City, Mexico
Arké SMO S.A de C.V-ARKE SMO S.A. de C.V. ( Site 2210)
Veracruz, Mexico
CGM Research Trust ( Site 2307)
Christchurch, Canterbury, New Zealand
Pacific Clinical Research Network - Tasman ( Site 2304)
Nelson, Tasman District, New Zealand
Lakeland Clinical Trials Waikato ( Site 2302)
Nawton, Waikato Region, New Zealand
Lakeland Clinical Trials Wellington ( Site 2303)
Upper Hutt, Wellington Region, New Zealand
Pacific Clinical Research Network West Auckland ( Site 2301)
Auckland, New Zealand
Optimal Clinical Trials North ( Site 2308)
Auckland, New Zealand
Silverdale Medical Limited ( Site 2305)
Auckland, New Zealand
Optimal Clinical Trials ( Site 2306)
Auckland, New Zealand
Asociación Civil Selva Amazónica ( Site 2405)
Iquitos, Loreto, Peru
Via Libre ( Site 2409)
Lima, Peru
Clinica Ricardo Palma-Centro de Investigacion de Enfermedades Respiratorias Thorax ( Site 2404)
Lima, Peru
Health Index Multispeciality Clinic ( Site 2501)
Bacoor, Cavite, Philippines
Ospital Ng Makati ( Site 2505)
Makati City, National Capital Region, Philippines
GreenCity Medical Center ( Site 2503)
San Fernando City, Pampanga, Philippines
PL Certus ( Site 2613)
Poznan, Greater Poland Voivodeship, Poland
In-Vivo Bydgoszcz ( Site 2601)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
NZOZ GynCentrum - Oddział Kraków ( Site 2609)
Krakow, Lesser Poland Voivodeship, Poland
Penta Hospitals Przychodnie Wrocław Wejherowska ( Site 2611)
Wroclaw, Lower Silesian Voivodeship, Poland
NZOZ GynCentrum - Oddział Bielsko-Biała ( Site 2602)
Bielsko-Biala, Silesian Voivodeship, Poland
Clinical Medical Research ( Site 2604)
Katowice, Silesian Voivodeship, Poland
Holsamed ( Site 2603)
Katowice, Silesian Voivodeship, Poland
Investigadores del Este LLC ( Site 4001)
Humacao, Puerto Rico
Miralles Clinical Research LLC ( Site 4004)
San Juan, Puerto Rico
MV HEALTH SERVICES LLC ( Site 4003)
San Juan, Puerto Rico
Spitalul Clinic de Boli Infecțioase și Tropicale Victor Babeș ( Site 2701)
Bucharest, București, Romania
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu ( Site 2705)
Baloteşti, Ilfov, Romania
Centrul Medical SANA ( Site 2704)
Bucharest, Romania
National Institute for Infectious Diseases Prof. Dr. Matei Bals ( Site 2706)
Bucharest, Romania
Spitalul Clinic de Boli Infecțioase ( Site 2703)
Cluj-Napoca, Romania
Spitalul Clinic de Boli Infecțioase ( Site 2702)
Constanța, Romania
Wonju Severance Christian Hospital-Internal Medicine ( Site 3009)
Wŏnju, Kang-won-do, South Korea
Chonnam National University Hospital-Infectious Diseases ( Site 3008)
Gwangju, Kwangju-Kwangyokshi, South Korea
Korea University Ansan Hospital ( Site 3007)
Ansan-si, Kyonggi-do, South Korea
Gyeongsang National University Hospital ( Site 3005)
Jinju, Kyongsangnam-do, South Korea
Pusan National University Hospital-Internal Medicine ( Site 3010)
Pusan, Pusan-Kwangyokshi, South Korea
Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3002)
Deagu, Taegu-Kwangyokshi, South Korea
Korea University Anam Hospital ( Site 3001)
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3003)
Seoul, South Korea
Korea University Guro Hospital ( Site 3006)
Seoul, South Korea
Hospital General Universitario de Elche-Infectius Disease ( Site 3105)
Elche, Alicante, Spain
Hospital Germans Trias i Pujol ( Site 3101)
Badalona, Barcelona, Spain
EAP Osona Sud - Alt Congost S.L.P ( Site 3107)
Centelles, Barcelona, Spain
Hospital Universitari Vall d'Hebron ( Site 3102)
Barcelona, Catalonia, Spain
Hospital Universitario de A Coruña ( Site 3112)
A Coruña, Galicia, Spain
Hospital Santa Lucia-Medicina Infecciosas ( Site 3106)
Cartagena, Murcia, Spain
EAP Sardenya ( Site 3109)
Barcelona, Spain
Hospital Universitario Infanta Leonor ( Site 3110)
Madrid, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 3100)
Seville, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3306)
Kaoshiung, Kaohsiung, Taiwan
Taoyuan General Hospital ( Site 3300)
Taoyuan, Taoyuan, Taiwan
Kaohsiung Veterans General Hospital ( Site 3307)
Kaohsiung City, Taiwan
Taipei Medical University - Shuang Ho Hospital ( Site 3308)
New Taipei City, Taiwan
Taichung Veterans General Hospital ( Site 3305)
Taichung, Taiwan
National Taiwan University Hospital ( Site 3301)
Taipei, Taiwan
Tri-Service General Hospital ( Site 3304)
Taipei, Taiwan
Taipei Municipal Wangfang Hospital ( Site 3309)
Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 3303)
Taoyuan District, Taiwan
Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 3401)
Bangkok, Bangkok, Thailand
HIV Netherlands Australia Thailand Research Collaboration ( Site 3402)
Pathumwan, Bangkok, Thailand
EUROMEDCLINIC ( Site 3517)
Cherkasy, Cherkasy Oblast, Ukraine
MUNICIPAL NON-PROFIT ENTERPRISE CENTRAL CITY CLINICAL HOSPITAL OF CHERNIVTSI CITY COUNCIL ( Site 3513)
Chernivtsi, Chernihiv Oblast, Ukraine
Clinical medical and diagnostic center Limited Liability Company "Simedgroup" ( Site 3524)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Regional Phthisiology and Pulmonology Center ( Site 3523)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 3537)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
Limited Liability Company Ukrainian Center of Tomotherapy-Clinical Trials Department ( Site 3512)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
Medical Center "Harmoniya Krasy" ( Site 3545)
Kyiv, Kyivska Oblast, Ukraine
Edelweiss Medics ( Site 3503)
Kyiv, Kyivska Oblast, Ukraine
Communal Non-Profit Enterprise "Kyiv City Clinical Hospital #1"-Department of Clinical Research ( Site 3514)
Kyiv, Kyivska Oblast, Ukraine
Medbud Clinic-Treatment prevention unit ( Site 3506)
Kyiv, Kyivska Oblast, Ukraine
Medical Center of Limited ( Site 3546)
Kyiv, Kyivska Oblast, Ukraine
Center of Family Medicine Plus ( Site 3502)
Kyiv, Kyivska Oblast, Ukraine
Polyclinic of Communal 4th city clinical hospital ( Site 3501)
Lviv, Lviv Oblast, Ukraine
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 3525)
Lviv, Lviv Oblast, Ukraine
University clinic of the National Pirogov Memorial Medical University ( Site 3547)
Vinnytsia, Vinnytsia Oblast, Ukraine
Clinic of Pyrohov National Medical University of Vinnytsia ( Site 3528)
Vinnytsia, Vinnytsia Oblast, Ukraine
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 3530)
Lutsk, Volyn Oblast, Ukraine
Uzhhorod Municipal Multidisciplinary Clinical Hospital of Uzhhorod City Council ( Site 3538)
Uzhhorod, Zakarpattia Oblast, Ukraine
Medlight Clinic ( Site 3548)
Kyiv, Ukraine
Kyiv Railway Clinical Hospital No.2 of Branch Health Center -Center of Clinical Trials ( Site 3549)
Kyiv, Ukraine
Whiteladies Medical Group ( Site 3611)
Bristol, Bristol, City of, United Kingdom
Royal Devon & Exeter Hospital ( Site 3604)
Exeter, England, United Kingdom
Royal Victoria Infirmary ( Site 3608)
Newcastle, Newcastle Upon Tyne, United Kingdom
Norwich Practices Health Centre ( Site 3605)
Norwich, Norfolk, United Kingdom
Oak Street Medical Practice ( Site 3612)
Norwich, Norfolk, United Kingdom
Lakeside Surgery ( Site 3600)
Northamptonshire, Northamptonshire, United Kingdom
Bicester Health Centre ( Site 3609)
Bicester, Oxfordshire, United Kingdom
Banbury Cross Health Centre ( Site 3610)
Oxford, Oxfordshire, United Kingdom
Buttercross Health Centre ( Site 3606)
Somerset, Somerset, United Kingdom