Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013) (MOVe-AHEAD)

September 10, 2024 updated by: Merck Sharp & Dohme LLC

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19

The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2441

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1431FWO
        • CEMIC ( Site 0101)
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1039AAO
        • Sanatorio de la Trinidad Mitre ( Site 0108)
      • Caba, Buenos Aires, Argentina, C1128AAF
        • Mautalen Salud e Investigacion ( Site 0103)
      • Caba, Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires ( Site 0102)
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)
      • Munro, Buenos Aires, Argentina, B1605FRE
        • Clinica Independencia ( Site 0104)
      • San Nicolas, Buenos Aires, Argentina, B2900DPA
        • Grupo Oroño Centro medico San Nicolas ( Site 0109)
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Instituto Medico de la Fundacion Estudios Clinicos ( Site 0106)
  • Brazil
      • Rio de Janeiro, Brazil, 22780-192
        • Centro de Referencia Professor Helio Fraga - FIOCRUZ/RJ ( Site 0314)
      • Sao Paulo, Brazil, 04121-000
        • Centro de Referência e Treinamento DST/AIDS ( Site 0301)
    • Amazonas
      • Manaus, Amazonas, Brazil, 69040-000
        • Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0303)
    • Mato Grosso Do Sul
      • Campo Grande, Mato Grosso Do Sul, Brazil, 79070-900
        • Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul - UFMS ( Site 0305)
    • Parana
      • Curitiba, Parana, Brazil, 80810-040
        • Hospital Nossa Senhora das Gracas ( Site 0310)
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700-000
        • Oncosite-Centro de Pesquisa Clinica em Oncologia ( Site 0300)
    • Sao Paulo
      • São José do Rio Preto, Sao Paulo, Brazil, 15090000
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0312)
  • Bulgaria
      • Kyustendil, Bulgaria, 2500
        • Medical Center Hera Kyustendi EOOD ( Site 3003)
      • Montana, Bulgaria, 3400
        • Medical Center Hera EOOD - Montana branch ( Site 3002)
    • Sofia (stolitsa)
      • Sofia, Sofia (stolitsa), Bulgaria, 1510
        • Medical Center Hera EOOD ( Site 3001)
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050021
        • Fundacion Centro de Investigacion Clinica CIC ( Site 0402)
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Centro Cientifico Asistencial Jose Luis Accini ( Site 0412)
      • Barranquilla, Atlantico, Colombia, 080020
        • Clinica de la Costa Ltda. ( Site 0407)
    • Cordoba
      • Monteria, Cordoba, Colombia, 230002
        • Oncomedica S.A. ( Site 0406)
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110411
        • Hospital Universitario Clinica San Rafael ( Site 0410)
      • Zipaquira, Cundinamarca, Colombia, 250252
        • Healthy Medical Center S.A.S ( Site 0413)
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 111211
        • Caja de Compensacion Familiar CAFAM ( Site 0403)
    • Risaralda
      • Pereira, Risaralda, Colombia, 660003
        • Fundacion Centro de Investigaciones Clinicas CARDIOMET ( Site 0409)
    • Santander
      • Bucaramanga, Santander, Colombia, 681004
        • Instituto Neumologico del Oriente S.A. ( Site 0408)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Fundacion Valle del Lili ( Site 0405)
  • Dominican Republic
    • Distrito Nacional
      • Santo Domingo, Distrito Nacional, Dominican Republic, 10605
        • Unidad de Aislamiento del Centro de Obstetricia y Ginecologia ( Site 2650)
  • Egypt
    • Al Jizah
      • Giza, Al Jizah, Egypt, 12651
        • National Center for allergies and chest ( Site 2940)
      • Giza, Al Jizah, Egypt, 12661
        • Imbaba Fevers Hospital ( Site 2945)
    • Al Qahirah
      • Cairo, Al Qahirah, Egypt, 11566
        • Masri - CRC - Ain Shams University ( Site 2900)
      • Cairo, Al Qahirah, Egypt, 11566
        • Masri - CRC - Ain Shams University ( Site 2910)
      • Cairo, Al Qahirah, Egypt, 11796
        • National Hepatology and Tropical Medicine Research Institute ( Site 2930)
      • Cairo, Al Qahirah, Egypt, 11835
        • Air Force Specialized Hospital Clinical Research Center ( Site 2920)
  • France
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31500
        • Maison de Sante Universitaire La Providence ( Site 0506)
    • Ile-de-France
      • Paris, Ile-de-France, France, 75013
        • Hôpital Pitié - Salpêtrière ( Site 0501)
    • La Reunion
      • Saint Pierre Cedex, La Reunion, France, 97448
        • CHU de la Reunion - Groupe Hospitalier Sud ( Site 0508)
    • Martinique
      • Fort-de-France, Martinique, France, 97200
        • CHU Martinique ( Site 0511)
    • Seine-Maritime
      • Neufchatel-en-Bray, Seine-Maritime, France, 76270
        • Maison de santé du Pays Neufchatelois ( Site 0507)
  • Guatemala
      • Guatemala, Guatemala, 01001
        • Centro de Investigaciones Pediatricas ( Site 0703)
      • Guatemala, Guatemala, 01001
        • Unidad de Diagnostico Cardiologico ( Site 0701)
      • Guatemala, Guatemala, 01009
        • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0702)
      • Guatemala, Guatemala, 01010
        • Clinica Privada ( Site 0705)
      • Guatemala, Guatemala, 01015
        • Private Clinic - Dr. Hugo Pezzarossi ( Site 0704)
  • Hungary
      • Budapest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum - OEC ( Site 0821)
      • Budapest, Hungary, 1171
        • Strazsahegy Medicina Bt ( Site 0823)
      • Zalaegerszeg, Hungary, 8900
        • Obudai Egeszsegugyi Centrum - Zalaegerszeg ( Site 0819)
    • Bekes
      • Oroshaza, Bekes, Hungary, 5900
        • LONA MEDIC Kft ( Site 0804)
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4031
        • Debreceni Egyetem Klinikai Kozpont- Infektologiai Klinika ( Site 0824)
    • Heves
      • Gyongyos, Heves, Hungary, 3200
        • Bugat Pal Korhaz ( Site 0817)
    • Szabolcs-Szatmar-Bereg
      • Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
        • Medifarma-98 Kft. ( Site 0808)
    • Veszprem
      • Balatonfured, Veszprem, Hungary, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft. ( Site 0801)
  • Japan
      • Chiba, Japan, 260-0852
        • Chiba Aoba Municipal Hospital ( Site 1100)
      • Tokyo, Japan, 102-0083
        • Global Healthcare Clinic ( Site 1106)
      • Tokyo, Japan, 145-0071
        • Den-en-chofu family clinic ( Site 1104)
      • Tokyo, Japan, 162-8655
        • Center Hospital of the National Center for Global Health and Medicine ( Site 1101)
      • Tokyo, Japan, 171-0014
        • Sekino Hospital ( Site 1110)
    • Chiba
      • Narita, Chiba, Japan, 286-8520
        • IUHW Narita Hospital ( Site 1105)
    • Okinawa
      • Ginowan, Okinawa, Japan, 901-2214
        • National Hospital Organization Okinawa National Hospital ( Site 1109)
      • Tomigusuku, Okinawa, Japan, 901-0224
        • Social Medical Corporation Yuuaikai Yuuai Medical Center ( Site 1108)
  • Kenya
      • Kisumu, Kenya, 40100
        • KEMRI-CMR-RCTP- Kenya Medical Research Institute Kisumu ( Site 1925)
    • Nairobi City
      • Nairobi, Nairobi City, Kenya, 00200
        • Center for Clinical Research (CCR) KEMRI ( Site 1929)
      • Nairobi, Nairobi City, Kenya, 00202
        • Partners in Health Research and Development PHRD ( Site 1928)
  • Malaysia
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Hospital Raja Perempuan Zainab II ( Site 2851)
    • Melaka
      • Masjid Tanah, Melaka, Malaysia, 78300
        • Klinik Kesihatan Masjid Tanah ( Site 2850)
  • Mexico
      • Aguascalientes, Mexico, 20116
        • Centro de Investigacion Medica Aguascalientes ( Site 1305)
      • Chihuahua, Mexico, 31000
        • ICARO Investigaciones en Medicina ( Site 1313)
      • Mexico City, Mexico, 14050
        • Medica Sur S.A.B de C.V. ( Site 1303)
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization S.C. ( Site 1304)
      • Veracruz, Mexico, 91910
        • Arké SMO S.A de C.V ( Site 1306)
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1308)
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Morales Vargas Centro de Investigacion, S.C. ( Site 1318)
    • Guerrero
      • Acapulco, Guerrero, Mexico, 39570
        • Hospital General de Acapulco ( Site 1319)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Instituto Jalisciense de Metabolismo SC ( Site 1314)
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62210
        • Centro Médico Universitario ( Site 1316)
    • Nuevo Leon
      • Gral Escobedo, Nuevo Leon, Mexico, 66055
        • CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 1315)
    • Quintana Roo
      • Cancun, Quintana Roo, Mexico, 77500
        • Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 1301)
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Köhler & Milstein Research S.A. de C.V. ( Site 1300)
  • Peru
      • Lima, Peru, 15036
        • Clínica Ricardo Palma ( Site 1406)
      • Lima, Peru, 15046
        • Asociacion Civil por la Salud ( Site 1411)
      • Lima, Peru, 15046
        • Investigaciones Medicas en Salud - INMENSA ( Site 1401)
      • Lima, Peru, 15088
        • Asociacion Civil IMPACTA Salud y Educacion - Sede San Miguel ( Site 1410)
      • Lima, Peru, 15088
        • Clinica Providencia ( Site 1400)
      • Lima, Peru, 15423
        • Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1404)
    • Qallaw
      • La Perla, Qallaw, Peru, 07011
        • Policlínico Especializado en Neurología - Unid. Inv. Neurológica ( Site 1403)
  • Philippines
      • Cavite, Philippines, 4102
        • Health Index Multi-Specialty and Lying -in Clinic ( Site 1504)
    • National Capital Region
      • Muntinlupa, National Capital Region, Philippines, 1780
        • Asian Hospital and Medical Center ( Site 1503)
      • Quezon City, National Capital Region, Philippines, 1109
        • Quirino Memorial Medical Center ( Site 1501)
  • Romania
      • Brasov, Romania, 500091
        • Centrul Medical Unirea ( Site 1705)
      • Bucharest, Romania, 011601
        • Centrul Medical Unirea SRL Bucuresti ( Site 1706)
      • Bucharest, Romania, 014142
        • Delta Heath Care S.R.L ( Site 1708)
      • Bucharest, Romania, 030463
        • SC Policlinica CCBR SRL. Bucuresti ( Site 1704)
      • Constanta, Romania, 900540
        • Centrul Medical Unirea SRL Constanta ( Site 1703)
      • Iasi, Romania, 700023
        • Centrul Medical Unirea SRL IASI ( Site 1701)
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400349
        • Centrul Medical Unirea SRL ( Site 1707)
    • Timis
      • Timisoara, Timis, Romania, 300645
        • S.C Materna Care SRL ( Site 1702)
  • Russian Federation
    • Moskva
      • Moscow, Moskva, Russian Federation, 121359
        • FSBI Central Hospital with Policlinics ( Site 1807)
      • Moscow, Moskva, Russian Federation, 125310
        • Infectious Clinical Hospital # 1 ( Site 1834)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 195427
        • SPb SBHI City outpatient clinic 112 ( Site 1829)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197376
        • Smorodintsev Research Institute of Influenza ( Site 1833)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 198510
        • Nikolaevskaya hospital ( Site 1810)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 199406
        • SPb SBHI City outpatient clinic 4 ( Site 1831)
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 196143
        • Limited liability company "Scientific research center Eco-safety" ( Site 1809)
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 198261
        • City Polyclinic #88 ( Site 1808)
      • Saint-Petrsburg, Sankt-Peterburg, Russian Federation, 190013
        • LLC -Medical Center . Capital-Polis ( Site 1825)
      • Saint-Petrsburg, Sankt-Peterburg, Russian Federation, 192289
        • St.Petersburg Outpatient Clinic No. 109 ( Site 1818)
      • St.Petersburg, Sankt-Peterburg, Russian Federation, 192071
        • SPb SBHI. City outpatient clinic No.44 ( Site 1830)
      • St.Petersburg, Sankt-Peterburg, Russian Federation, 196084
        • Medical Research Institute LLC. ( Site 1814)
    • Smolenskaya Oblast
      • Smolensk, Smolenskaya Oblast, Russian Federation, 214019
        • Smolensk State Medical Academy ( Site 1803)
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420140
        • Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1802)
    • Voronezskaja Oblast
      • Voronezh, Voronezskaja Oblast, Russian Federation, 394066
        • Voronezh Regional Clinical Hospital #1 ( Site 1823)
    • Yaroslavskaya Oblast
      • Yaroslavl, Yaroslavskaya Oblast, Russian Federation, 150001
        • LLC -Clinic of modern medicine of Doctor Bogorodskaya ( Site 1828)
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9300
        • IATROS International ( Site 1921)
    • Gauteng
      • Boksburg, Gauteng, South Africa, 1459
        • REIMED Reiger Park ( Site 1910)
      • Halfway House, Gauteng, South Africa, 1685
        • Midrand Medical Centre ( Site 1913)
      • Johannesburg, Gauteng, South Africa, 2041
        • Wits Health Consortium. Clinical HIV Research Unit ( Site 1923)
      • Johannesburg, Gauteng, South Africa, 2087
        • Right To Care Research - Esizayo ( Site 1907)
      • Krugersdorp, Gauteng, South Africa, 1739
        • DJW Navorsing ( Site 1915)
      • Moloto, Gauteng, South Africa, 1022
        • Zinakekele Medical Centre ( Site 1926)
      • Mpumalanga, Gauteng, South Africa, 1055
        • Mzansi Ethical Research Centre ( Site 1918)
      • Pretoria, Gauteng, South Africa, 0186
        • Global Clinical Trial Centre ( Site 1904)
      • Pretoria-West, Gauteng, South Africa, 0183
        • Jongaie Research ( Site 1900)
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4091
        • Dr Jugnundun & Partners ( Site 1905)
      • Durban, Kwazulu-Natal, South Africa, 4091
        • Enhancing Care Foundation-DICRS ( Site 1922)
      • Durban, Kwazulu-Natal, South Africa, 4093
        • Private Practice - Dr. Neyaseelan Gounden ( Site 1911)
    • Limpopo
      • Thabazimbi, Limpopo, South Africa, 0380
        • Limpopo Clinical Research Initiative ( Site 1901)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • TASK Applied Science ( Site 1920)
      • Cape Town, Western Cape, South Africa, 7975
        • DTHF Masiphumelele Clinical Research Site ( Site 1919)
      • Paarl, Western Cape, South Africa, 7626
        • Be Part Yoluntu Centre ( Site 1914)
      • Paarl, Western Cape, South Africa, 7646
        • Paarl Research Centre ( Site 1924)
  • Spain
      • Barcelona, Spain, 08023
        • C.S. Vallcarca-Sant Gervasi ( Site 2000)
      • Barcelona, Spain, 08025
        • CAP de Sardenya ( Site 2009)
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor ( Site 2002)
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz ( Site 2024)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol ( Site 2010)
      • Centelles, Barcelona, Spain, 08540
        • CAP Centelles ( Site 2011)
    • Madrid, Comunidad De
      • Alcorcon, Madrid, Comunidad De, Spain, 28922
        • Hospital de Alcorcon ( Site 2003)
  • Thailand
    • Krung Thep Maha Nakhon
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10330
        • HIV-NAT AIDS Research Centre ( Site 2804)
      • Lak Si, Krung Thep Maha Nakhon, Thailand, 10210
        • Chulabhorn Hospital ( Site 2801)
      • Ratchathewi, Krung Thep Maha Nakhon, Thailand, 10400
        • Rajavithi Hospital ( Site 2803)
    • Nakhon Pathom
      • Phutthamonthon, Nakhon Pathom, Thailand, 73170
        • The Golden Jubilee Medical Center ( Site 2800)
    • Songkhla
      • Hat-Yai, Songkhla, Thailand, 90110
        • Songklanagarind Hospital ( Site 2802)
  • Turkey
      • Ankara, Turkey, 06230
        • Ankara Universitesi Ibni Sina Hastanesi ( Site 2101)
      • Ankara, Turkey, 06230
        • Hacettepe Universitesi Tip Fakultesi ( Site 2102)
      • Ankara, Turkey, 06560
        • Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2106)
      • Ankara, Turkey, 06800
        • Ankara Sehir Hastanesi ( Site 2111)
      • Istanbul, Turkey, 34093
        • Istanbul Universitesi Istanbul Tip Fakultesi ( Site 2110)
      • Istanbul, Turkey, 34214
        • Medipol Universite Hastanesi ( Site 2108)
      • Istanbul, Turkey, 34494
        • Basaksehir Cam ve Sakura City Hospital ( Site 2112)
      • Istanbul, Turkey, 34785
        • Sancaktepe Prof Dr Ilhan Varank EAH-Prof Dr Feriha Oz Hastanesi ( Site 2113)
      • Izmir, Turkey, 35100
        • Ege Universitesi Tip Fakultesi Hastanesi ( Site 2105)
      • Sakarya, Turkey, 54100
        • Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2107)
    • Istanbul
      • Halkali/K.cekmece, Istanbul, Turkey, 34303
        • Atakent Acibadem Hastanesi ( Site 2103)
  • Ukraine
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76007
        • Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 2232)
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
        • Regional Phthisiopulmonological Center ( Site 2203)
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76025
        • NPME -Central Clinical Hospital of Ivano-Frankivsk City Council ( Site 2204)
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61002
        • Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 2229)
      • Kharkiv, Kharkivska Oblast, Ukraine, 61172
        • PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 2201)
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 01033
        • Limited Liability Company Medical center Healthy Happy ( Site 2225)
      • Kyiv, Kyivska Oblast, Ukraine, 02232
        • MNPE Consultative-Diagnostic Centre of Desnyanskyi District of Kyiv ( Site 2205)
      • Kyiv, Kyivska Oblast, Ukraine, 03049
        • Kyiv railway clinical hospital 2 of Branch Health center ( Site 2207)
    • Lvivska Oblast
      • Lviv, Lvivska Oblast, Ukraine, 79011
        • Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 2200)
    • Odeska Oblast
      • Odesa, Odeska Oblast, Ukraine, 65014
        • Odesa Regional Center of Socially Significant Diseases ( Site 2230)
      • Odessa, Odeska Oblast, Ukraine, 65025
        • MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 2226)
    • Poltavska Oblast
      • Poltava, Poltavska Oblast, Ukraine, 36011
        • Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 2227)
    • Vinnytska Oblast
      • Vinnytsia, Vinnytska Oblast, Ukraine, 21009
        • Medical Clinical Investigational Center of Medical Center Health Clinic ( Site 2210)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Cahaba Research, Inc. ( Site 2523)
    • Arizona
      • Mesa, Arizona, United States, 85210
        • The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2484)
      • Tucson, Arizona, United States, 85712
        • The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2448)
    • California
      • Canoga Park, California, United States, 91303
        • Hope Clinical Research ( Site 2400)
      • Carlsbad, California, United States, 92009
        • Carbon Health ( Site 2515)
      • Fresno, California, United States, 93701
        • UCSF Fresno ( Site 2528)
      • Fullerton, California, United States, 92835
        • ASCADA Research, LLC ( Site 2516)
      • Huntington Beach, California, United States, 92647
        • Marvel Clinical Research ( Site 2490)
      • Los Angeles, California, United States, 90057
        • National Research Institute ( Site 2452)
      • Northridge, California, United States, 91325
        • Valley Clinical Trials Inc. ( Site 2406)
      • Oakland, California, United States, 94610
        • Carbon Health ( Site 2514)
      • Sacramento, California, United States, 95817
        • University of California Davis ( Site 2497)
      • Simi Valley, California, United States, 93065
        • Millennium Clinical Trials ( Site 2468)
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Future Innovative Treatments, LLC ( Site 2471)
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Emerson Clinical Research Institute ( Site 2457)
    • Florida
      • Bradenton, Florida, United States, 34208
        • Synergy Healthcare ( Site 2521)
      • DeLand, Florida, United States, 32720
        • Accel Research Sites-DeLand Clinical Research Unit ( Site 2535)
      • Hallandale Beach, Florida, United States, 33009
        • Velocity Clinical Research, Hallandale Beach ( Site 2485)
      • Hialeah, Florida, United States, 33012
        • Indago Research and Health Center Inc ( Site 2412)
      • Immokalee, Florida, United States, 34142
        • Advanced Research For Health Improvement LLC ( Site 2436)
      • Miami, Florida, United States, 33186
        • Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2508)
      • Port Saint Lucie, Florida, United States, 34952
        • CDC Research Institute, LLC ( Site 2540)
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida ( Site 2402)
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2425)
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Balanced Life Healthcare Solutions/SKYCRNG ( Site 2539)
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Chicago Clinical Research Institute Inc ( Site 2454)
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center ( Site 2510)
    • Louisiana
      • Metairie, Louisiana, United States, 70001
        • Southern Clinical Research Associates ( Site 2542)
      • Metairie, Louisiana, United States, 70006
        • MedPharmics, LLC ( Site 2443)
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Institute of Human Virology ( Site 2504)
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Group ( Site 2435)
      • Silver Spring, Maryland, United States, 20904
        • Jadestone Clinical Research, LLC ( Site 2530)
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Michigan Center of Medical Research ( Site 2445)
      • Lathrup Village, Michigan, United States, 48076
        • Michigan Center of Medical Research ( Site 2525)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Allina Health Infectious Diseases Research Clinic ( Site 2507)
    • Mississippi
      • Fayette, Mississippi, United States, 39069
        • Prime Health and Wellness/SKYCRNG ( Site 2538)
      • Ridgeland, Mississippi, United States, 39157
        • Quinn Healthcare/Skycrng ( Site 2537)
    • Missouri
      • Columbia, Missouri, United States, 65201
        • University of Missouri Hospital ( Site 2486)
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group PLLC ( Site 2476)
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3135
        • University of Nebraska Medical Center ( Site 2430)
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research, LLC ( Site 2404)
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • ID Care ( Site 2466)
      • Raritan, New Jersey, United States, 08869
        • Amici Clinical Research LLC ( Site 2426)
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • AXCES Research Group ( Site 2437)
    • New York
      • Bronx, New York, United States, 10462
        • Montefiore Medical Center ( Site 2503)
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • ECU Adult Specialty Care ( Site 2415)
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Center for Research and Education at The Christ Hospital ( Site 2517)
      • Dayton, Ohio, United States, 45406
        • Dayton Clinical Research ( Site 2488)
    • Oklahoma
      • Tahlequah, Oklahoma, United States, 74464
        • Cherokee Nation WW Hastings Indian Hospital/Cherokee Nation Health Services ( Site 2459)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Clinical Research ( Site 2470)
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Velocity Clinical Research-Providence ( Site 2432)
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC ( Site 2409)
    • Texas
      • Amarillo, Texas, United States, 79109
        • PharmaTex Research, LLC ( Site 2541)
      • Boerne, Texas, United States, 78006
        • TTS Research ( Site 2433)
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital ( Site 2463)
      • Houston, Texas, United States, 77087
        • Santa Clara Family Clinic ( Site 2462)
      • Victoria, Texas, United States, 77901
        • Crossroads Clinical Research LLC ( Site 2451)
    • Virginia
      • Williamsburg, Virginia, United States, 23188
        • TPMG Clinical Research ( Site 2495)
    • Washington
      • Seattle, Washington, United States, 98109
        • Covid-19 Clinical Research Center (CCRC) ( Site 2421)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Lives in a household with an index case where the index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have 1) a first detectable SARS-CoV-2 test result from a sample collected within ≤5 days prior to randomization of the participant, and 2) at least 1 symptom attributable to COVID-19 (e.g., fever, difficulty breathing)
  • Does not have confirmed or suspected COVID-19
  • Is willing and able to take oral medication
  • For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for ≥3 months after the last dose of study drug
  • Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method), or is a WOCBP who is abstinent from heterosexual intercourse

Exclusion Criteria:

  • Has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms) within 6 months prior to randomization
  • Has either of the following: human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL (regardless of CD4 count) or an acquired immunodeficiency syndrome (AIDS)-defining illness
  • Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with any of the following: cirrhosis, end-stage liver disease, hepatocellular carcinoma; aspartate transaminase (AST) and/or (ALT) >3x upper limit of normal at screening
  • 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 with conditions that could limit gastrointestinal absorption of capsule contents
  • Has received, is taking, or is anticipated to require any prohibited therapies
  • Has received a COVID-19 vaccination with the first dose ≥7 days prior to randomization
  • 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
  • Is living in a household with >10 people

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Molnupiravir
Participants take molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
Drug: Molnupiravir
Four molnupiravir 200 mg capsules taken by mouth.
Other Names:
  • MK-4482
Placebo Comparator: Placebo
Participants take placebo Q12H on Days 1 to 5.
Drug: Placebo
Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline Nasopharyngeal (NP) Swabs and Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14
Time Frame: Day 14
Percentage of participants who had undetectable SARS-CoV-2 in baseline NP swabs and developed COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14 were reported.
Day 14
Percentage of Participants With ≥1 Adverse Event
Time Frame: 29 days
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.
29 days
Percentage of Participants Discontinuing From Study Therapy Due to AE
Time Frame: Up to 5 days
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
Percentage of Participants (Regardless of SARS-CoV-2 in Baseline NP Swabs) Who Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14
Time Frame: Up to Day 14
Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
Up to Day 14
Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline NP Swabs and Developed COVID-19 (Laboratory-Confirmed SARS-CoV-2 Infection With Symptoms) Through Day 29
Time Frame: Up to Day 29
Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using RT-PCR. The efficacy analysis population was the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
Up to Day 29
Percentage of Participants Who Had Undetectable SARS-CoV-2 in Baseline NP Swabs and Developed Detectable SARS-CoV-2 in NP Swabs on or Before Day 14
Time Frame: Up to Day 14
All participants had NP swabs collected at screening and through Day 14 to test for SARS-CoV-2 using RT-PCR. Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
Up to Day 14
Percentage of Participants Who Had Detectable SARS-CoV-2 in Baseline NP Swabs and Developed COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) Through Day 14
Time Frame: Up to Day 14
Participants who experienced targeted symptoms of COVID-19 (e.g., cough, sore throat) and had NP swabs tested for SARS-CoV-2 using RT-PCR. Efficacy analysis was conducted on the mITT (modified intent to treat) population consisting of all randomized participants who received at least 1 dose of study intervention.
Up to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2021

Primary Completion (Actual)

November 16, 2022

Study Completion (Actual)

November 16, 2022

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

June 25, 2021

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 10, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4482-013
  • MK-4482-013 (Other Identifier: MSD)
  • jRCT2031210281 (Registry Identifier: jRCT (Japan Registry of Clinical Trials))
  • PHRR211007-003980 (Registry Identifier: PHRR)
  • 2021-000904-39 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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