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

NCT04939428 | Completed Phase 3 Results DMC FDA Drug

• 5 other identifiers: 4482-013MK-4482-013jRCT2031210281PHRR211007-0039802021-000904-39
• Study Type: interventional
• Target: 2,441
• Locations: 23 countries
• Sites: 226

Brief Summary

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.

Conditions

Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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 Outcomes (4)

• 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

  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

  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

  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

  Up to Day 14

Study Arms (2)

Molnupiravir

EXPERIMENTAL

Participants take molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.

Drug: Molnupiravir

Placebo

PLACEBO COMPARATOR

Participants take placebo Q12H on Days 1 to 5.

Drug: Placebo

Interventions

Molnupiravir DRUG

Four molnupiravir 200 mg capsules taken by mouth.

Also known as: MK-4482

Molnupiravir

Placebo DRUG

Placebo capsule matched to molnupiravir 200 mg capsules taken by mouth.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (226)

Cahaba Research, Inc. ( Site 2523)

Birmingham, Alabama, 35235, United States

Location

The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2484)

Mesa, Arizona, 85210, United States

Location

The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2448)

Tucson, Arizona, 85712, United States

Location

Hope Clinical Research ( Site 2400)

Canoga Park, California, 91303, United States

Location

Carbon Health ( Site 2515)

Carlsbad, California, 92009, United States

Location

UCSF Fresno ( Site 2528)

Fresno, California, 93701, United States

Location

ASCADA Research, LLC ( Site 2516)

Fullerton, California, 92835, United States

Location

Marvel Clinical Research ( Site 2490)

Huntington Beach, California, 92647, United States

Location

National Research Institute ( Site 2452)

Los Angeles, California, 90057, United States

Location

Valley Clinical Trials Inc. ( Site 2406)

Northridge, California, 91325, United States

Location

Carbon Health ( Site 2514)

Oakland, California, 94610, United States

Location

University of California Davis ( Site 2497)

Sacramento, California, 95817, United States

Location

Millennium Clinical Trials ( Site 2468)

Simi Valley, California, 93065, United States

Location

Future Innovative Treatments, LLC ( Site 2471)

Colorado Springs, Colorado, 80907, United States

Location

Emerson Clinical Research Institute ( Site 2457)

Washington D.C., District of Columbia, 20011, United States

Location

Synergy Healthcare ( Site 2521)

Bradenton, Florida, 34208, United States

Location

Accel Research Sites-DeLand Clinical Research Unit ( Site 2535)

DeLand, Florida, 32720, United States

Location

Velocity Clinical Research, Hallandale Beach ( Site 2485)

Hallandale, Florida, 33009, United States

Location

Indago Research and Health Center Inc ( Site 2412)

Hialeah, Florida, 33012, United States

Location

Advanced Research For Health Improvement LLC ( Site 2436)

Immokalee, Florida, 34142, United States

Location

Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2508)

Miami, Florida, 33186, United States

Location

CDC Research Institute, LLC ( Site 2540)

Port Saint Lucie, Florida, 34952, United States

Location

Clinical Research Trials of Florida ( Site 2402)

Tampa, Florida, 33607, United States

Location

Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2425)

Winter Park, Florida, 32789, United States

Location

Balanced Life Healthcare Solutions/SKYCRNG ( Site 2539)

Lawrenceville, Georgia, 30046, United States

Location

Chicago Clinical Research Institute Inc ( Site 2454)

Chicago, Illinois, 60607, United States

Location

Rush University Medical Center ( Site 2510)

Chicago, Illinois, 60612, United States

Location

Southern Clinical Research Associates ( Site 2542)

Metairie, Louisiana, 70001, United States

Location

MedPharmics, LLC ( Site 2443)

Metairie, Louisiana, 70006, United States

Location

Institute of Human Virology ( Site 2504)

Baltimore, Maryland, 21201, United States

Location

Centennial Medical Group ( Site 2435)

Elkridge, Maryland, 21075, United States

Location

Jadestone Clinical Research, LLC ( Site 2530)

Silver Spring, Maryland, 20904, United States

Location

Michigan Center of Medical Research ( Site 2445)

Farmington Hills, Michigan, 48334, United States

Location

Michigan Center of Medical Research ( Site 2525)

Lathrup Village, Michigan, 48076, United States

Location

Allina Health Infectious Diseases Research Clinic ( Site 2507)

Minneapolis, Minnesota, 55404, United States

Location

Prime Health and Wellness/SKYCRNG ( Site 2538)

Fayette, Mississippi, 39069, United States

Location

Quinn Healthcare/Skycrng ( Site 2537)

Ridgeland, Mississippi, 39157, United States

Location

University of Missouri Hospital ( Site 2486)

Columbia, Missouri, 65201, United States

Location

Mercury Street Medical Group PLLC ( Site 2476)

Butte, Montana, 59701, United States

Location

University of Nebraska Medical Center ( Site 2430)

Omaha, Nebraska, 68198-3135, United States

Location

Excel Clinical Research, LLC ( Site 2404)

Las Vegas, Nevada, 89109, United States

Location

ID Care ( Site 2466)

Hillsborough, New Jersey, 08844, United States

Location

Amici Clinical Research LLC ( Site 2426)

Raritan, New Jersey, 08869, United States

Location

AXCES Research Group ( Site 2437)

Santa Fe, New Mexico, 87505, United States

Location

Montefiore Medical Center ( Site 2503)

The Bronx, New York, 10462, United States

Location

ECU Adult Specialty Care ( Site 2415)

Greenville, North Carolina, 27834, United States

Location

The Lindner Center for Research and Education at The Christ Hospital ( Site 2517)

Cincinnati, Ohio, 45219, United States

Location

Dayton Clinical Research ( Site 2488)

Dayton, Ohio, 45406, United States

Location

Cherokee Nation WW Hastings Indian Hospital/Cherokee Nation Health Services ( Site 2459)

Tahlequah, Oklahoma, 74464, United States

Location

Preferred Clinical Research ( Site 2470)

Pittsburgh, Pennsylvania, 15236, United States

Location

Velocity Clinical Research-Providence ( Site 2432)

East Greenwich, Rhode Island, 02818, United States

Location

Tribe Clinical Research, LLC ( Site 2409)

Greenville, South Carolina, 29607, United States

Location

PharmaTex Research, LLC ( Site 2541)

Amarillo, Texas, 79109, United States

Location

TTS Research ( Site 2433)

Boerne, Texas, 78006, United States

Location

Houston Methodist Hospital ( Site 2463)

Houston, Texas, 77030, United States

Location

Santa Clara Family Clinic ( Site 2462)

Houston, Texas, 77087, United States

Location

Crossroads Clinical Research LLC ( Site 2451)

Victoria, Texas, 77901, United States

Location

TPMG Clinical Research ( Site 2495)

Williamsburg, Virginia, 23188, United States

Location

Covid-19 Clinical Research Center (CCRC) ( Site 2421)

Seattle, Washington, 98109, United States

Location

Sanatorio de la Trinidad Mitre ( Site 0108)

CABA, Buenos Aires, C1039AAO, Argentina

Location

Mautalen Salud e Investigacion ( Site 0103)

Caba, Buenos Aires, C1128AAF, Argentina

Location

Hospital Italiano de Buenos Aires ( Site 0102)

CABA, Buenos Aires, C1199ABB, Argentina

Location

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0105)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Clinica Independencia ( Site 0104)

Munro, Buenos Aires, B1605FRE, Argentina

Location

Grupo Oroño Centro medico San Nicolas ( Site 0109)

San Nicolás de los Arroyos, Buenos Aires, B2900DPA, Argentina

Location

Instituto Medico de la Fundacion Estudios Clinicos ( Site 0106)

Rosario, Santa Fe Province, 2000, Argentina

Location

CEMIC ( Site 0101)

Buenos Aires, C1431FWO, Argentina

Location

Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0303)

Manaus, Amazonas, 69040-000, Brazil

Location

Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul - UFMS ( Site 0305)

Campo Grande, Mato Grosso do Sul, 79070-900, Brazil

Location

Hospital Nossa Senhora das Gracas ( Site 0310)

Curitiba, Paraná, 80810-040, Brazil

Location

Oncosite-Centro de Pesquisa Clinica em Oncologia ( Site 0300)

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0312)

São José do Rio Preto, São Paulo, 15090000, Brazil

Location

Centro de Referencia Professor Helio Fraga - FIOCRUZ/RJ ( Site 0314)

Rio de Janeiro, 22780-192, Brazil

Location

Centro de Referência e Treinamento DST/AIDS ( Site 0301)

São Paulo, 04121-000, Brazil

Location

Medical Center Hera EOOD ( Site 3001)

Sofia, Sofia (stolitsa), 1510, Bulgaria

Location

Medical Center Hera Kyustendi EOOD ( Site 3003)

Kyustendil, 2500, Bulgaria

Location

Medical Center Hera EOOD - Montana branch ( Site 3002)

Montana, 3400, Bulgaria

Location

Fundacion Centro de Investigacion Clinica CIC ( Site 0402)

Medellín, Antioquia, 050021, Colombia

Location

Centro Cientifico Asistencial Jose Luis Accini ( Site 0412)

Barranquilla, Atlántico, 080020, Colombia

Location

Clinica de la Costa Ltda. ( Site 0407)

Barranquilla, Atlántico, 080020, Colombia

Location

Caja de Compensacion Familiar CAFAM ( Site 0403)

Bogotá, Bogota D.C., 111211, Colombia

Location

Hospital Universitario Clinica San Rafael ( Site 0410)

Bogota, Cundinamarca, 110411, Colombia

Location

Healthy Medical Center S.A.S ( Site 0413)

Zipaquirá, Cundinamarca, 250252, Colombia

Location

Oncomedica S.A. ( Site 0406)

Montería, Departamento de Córdoba, 230002, Colombia

Location

Fundacion Centro de Investigaciones Clinicas CARDIOMET ( Site 0409)

Pereira, Risaralda Department, 660003, Colombia

Location

Instituto Neumologico del Oriente S.A. ( Site 0408)

Bucaramanga, Santander Department, 681004, Colombia

Location

Fundacion Valle del Lili ( Site 0405)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Unidad de Aislamiento del Centro de Obstetricia y Ginecologia ( Site 2650)

Santo Domingo, Nacional, 10605, Dominican Republic

Location

Masri - CRC - Ain Shams University ( Site 2900)

Cairo, Cairo Governorate, 11566, Egypt

Location

Masri - CRC - Ain Shams University ( Site 2910)

Cairo, Cairo Governorate, 11566, Egypt

Location

National Hepatology and Tropical Medicine Research Institute ( Site 2930)

Cairo, Cairo Governorate, 11796, Egypt

Location

Air Force Specialized Hospital Clinical Research Center ( Site 2920)

Cairo, Cairo Governorate, 11835, Egypt

Location

National Center for allergies and chest ( Site 2940)

Giza, Giza Governorate, 12651, Egypt

Location

Imbaba Fevers Hospital ( Site 2945)

Giza, Giza Governorate, 12661, Egypt

Location

Maison de Sante Universitaire La Providence ( Site 0506)

Toulouse, Haute-Garonne, 31500, France

Location

CHU de la Reunion - Groupe Hospitalier Sud ( Site 0508)

Saint-Pierre, La Reunion, 97448, France

Location

CHU Martinique ( Site 0511)

Fort-de-France, Martinique, 97200, France

Location

Maison de santé du Pays Neufchatelois ( Site 0507)

Neufchâtel-en-Bray, Seine-Maritime, 76270, France

Location

Hôpital Pitié - Salpêtrière ( Site 0501)

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

Location

Centro de Investigaciones Pediatricas ( Site 0703)

Guatemala City, 01001, Guatemala

Location

Unidad de Diagnostico Cardiologico ( Site 0701)

Guatemala City, 01001, Guatemala

Location

Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0702)

Guatemala City, 01009, Guatemala

Location

Clinica Privada ( Site 0705)

Guatemala City, 01010, Guatemala

Location

Private Clinic - Dr. Hugo Pezzarossi ( Site 0704)

Guatemala City, 01015, Guatemala

Location

LONA MEDIC Kft ( Site 0804)

Orosháza, Bekes County, 5900, Hungary

Location

Debreceni Egyetem Klinikai Kozpont- Infektologiai Klinika ( Site 0824)

Debrecen, Hajdú-Bihar, 4031, Hungary

Location

Bugat Pal Korhaz ( Site 0817)

Gyöngyös, Heves County, 3200, Hungary

Location

Medifarma-98 Kft. ( Site 0808)

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

DRC Gyogyszervizsgalo Kozpont Kft. ( Site 0801)

Balatonfüred, Veszprém megye, 8230, Hungary

Location

Obudai Egeszsegugyi Centrum - OEC ( Site 0821)

Budapest, 1036, Hungary

Location

Strazsahegy Medicina Bt ( Site 0823)

Budapest, 1171, Hungary

Location

Obudai Egeszsegugyi Centrum - Zalaegerszeg ( Site 0819)

Zalaegerszeg, 8900, Hungary

Location

IUHW Narita Hospital ( Site 1105)

Narita, Chiba, 286-8520, Japan

Location

National Hospital Organization Okinawa National Hospital ( Site 1109)

Ginowan, Okinawa, 901-2214, Japan

Location

Social Medical Corporation Yuuaikai Yuuai Medical Center ( Site 1108)

Tomigusuku, Okinawa, 901-0224, Japan

Location

Chiba Aoba Municipal Hospital ( Site 1100)

Chiba, 260-0852, Japan

Location

Global Healthcare Clinic ( Site 1106)

Tokyo, 102-0083, Japan

Location

Den-en-chofu family clinic ( Site 1104)

Tokyo, 145-0071, Japan

Location

Center Hospital of the National Center for Global Health and Medicine ( Site 1101)

Tokyo, 162-8655, Japan

Location

Sekino Hospital ( Site 1110)

Tokyo, 171-0014, Japan

Location

Center for Clinical Research (CCR) KEMRI ( Site 1929)

Nairobi, Nairobi City, 00200, Kenya

Location

Partners in Health Research and Development PHRD ( Site 1928)

Nairobi, Nairobi City, 00202, Kenya

Location

KEMRI-CMR-RCTP- Kenya Medical Research Institute Kisumu ( Site 1925)

Kisumu, 40100, Kenya

Location

Hospital Raja Perempuan Zainab II ( Site 2851)

Kota Bharu, Kelantan, 15586, Malaysia

Location

Klinik Kesihatan Masjid Tanah ( Site 2850)

Masjid Tanah, Melaka, 78300, Malaysia

Location

Morales Vargas Centro de Investigacion, S.C. ( Site 1318)

León, Guanajuato, 37000, Mexico

Location

Hospital General de Acapulco ( Site 1319)

Acapulco de Juárez, Guerrero, 39570, Mexico

Location

Instituto Jalisciense de Metabolismo SC ( Site 1314)

Guadalajara, Jalisco, 44670, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1308)

Mexico City, Mexico City, 14080, Mexico

Location

Centro Médico Universitario ( Site 1316)

Cuernavaca, Morelos, 62210, Mexico

Location

CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 1315)

General Escobedo, Nuevo León, 66055, Mexico

Location

Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 1301)

Cancún, Quintana Roo, 77500, Mexico

Location

Köhler & Milstein Research S.A. de C.V. ( Site 1300)

Mérida, Yucatán, 97070, Mexico

Location

Centro de Investigacion Medica Aguascalientes ( Site 1305)

Aguascalientes, 20116, Mexico

Location

ICARO Investigaciones en Medicina ( Site 1313)

Chihuahua City, 31000, Mexico

Location

Medica Sur S.A.B de C.V. ( Site 1303)

Mexico City, 14050, Mexico

Location

Oaxaca Site Management Organization S.C. ( Site 1304)

Oaxaca City, 68000, Mexico

Location

Arké SMO S.A de C.V ( Site 1306)

Veracruz, 91910, Mexico

Location

Policlínico Especializado en Neurología - Unid. Inv. Neurológica ( Site 1403)

La Perla, Qallaw, 07011, Peru

Location

Clínica Ricardo Palma ( Site 1406)

Lima, 15036, Peru

Location

Asociacion Civil por la Salud ( Site 1411)

Lima, 15046, Peru

Location

Investigaciones Medicas en Salud - INMENSA ( Site 1401)

Lima, 15046, Peru

Location

Asociacion Civil IMPACTA Salud y Educacion - Sede San Miguel ( Site 1410)

Lima, 15088, Peru

Location

Clinica Providencia ( Site 1400)

Lima, 15088, Peru

Location

Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1404)

Lima, 15423, Peru

Location

Asian Hospital and Medical Center ( Site 1503)

Muntinlupa, National Capital Region, 1780, Philippines

Location

Quirino Memorial Medical Center ( Site 1501)

Quezon City, National Capital Region, 1109, Philippines

Location

Health Index Multi-Specialty and Lying -in Clinic ( Site 1504)

Cavite, 4102, Philippines

Location

Centrul Medical Unirea SRL ( Site 1707)

Cluj-Napoca, Cluj, 400349, Romania

Location

S.C Materna Care SRL ( Site 1702)

Timișoara, Timiș County, 300645, Romania

Location

Centrul Medical Unirea ( Site 1705)

Brasov, 500091, Romania

Location

Centrul Medical Unirea SRL Bucuresti ( Site 1706)

Bucharest, 011601, Romania

Location

Delta Heath Care S.R.L ( Site 1708)

Bucharest, 014142, Romania

Location

SC Policlinica CCBR SRL. Bucuresti ( Site 1704)

Bucharest, 030463, Romania

Location

Centrul Medical Unirea SRL Constanta ( Site 1703)

Constanța, 900540, Romania

Location

Centrul Medical Unirea SRL IASI ( Site 1701)

Iași, 700023, Romania

Location

FSBI Central Hospital with Policlinics ( Site 1807)

Moscow, Moscow, 121359, Russia

Location

Infectious Clinical Hospital # 1 ( Site 1834)

Moscow, Moscow, 125310, Russia

Location

SPb SBHI. City outpatient clinic No.44 ( Site 1830)

Saint Petersburg, Sankt-Peterburg, 192071, Russia

Location

SPb SBHI City outpatient clinic 112 ( Site 1829)

Saint Petersburg, Sankt-Peterburg, 195427, Russia

Location

Medical Research Institute LLC. ( Site 1814)

Saint Petersburg, Sankt-Peterburg, 196084, Russia

Location

Limited liability company "Scientific research center Eco-safety" ( Site 1809)

Saint Petersburg, Sankt-Peterburg, 196143, Russia

Location

Smorodintsev Research Institute of Influenza ( Site 1833)

Saint Petersburg, Sankt-Peterburg, 197376, Russia

Location

City Polyclinic #88 ( Site 1808)

Saint Petersburg, Sankt-Peterburg, 198261, Russia

Location

Nikolaevskaya hospital ( Site 1810)

Saint Petersburg, Sankt-Peterburg, 198510, Russia

Location

SPb SBHI City outpatient clinic 4 ( Site 1831)

Saint Petersburg, Sankt-Peterburg, 199406, Russia

Location

LLC -Medical Center . Capital-Polis ( Site 1825)

Saint-Petrsburg, Sankt-Peterburg, 190013, Russia

Location

St.Petersburg Outpatient Clinic No. 109 ( Site 1818)

Saint-Petrsburg, Sankt-Peterburg, 192289, Russia

Location

Smolensk State Medical Academy ( Site 1803)

Smolensk, Smolensk Oblast, 214019, Russia

Location

Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1802)

Kazan', Tatarstan, Respublika, 420140, Russia

Location

Voronezh Regional Clinical Hospital #1 ( Site 1823)

Voronezh, Voronezskaja Oblast, 394066, Russia

Location

LLC -Clinic of modern medicine of Doctor Bogorodskaya ( Site 1828)

Yaroslavl, Yaroslavl Oblast, 150001, Russia

Location

IATROS International ( Site 1921)

Bloemfontein, Free State, 9300, South Africa

Location

REIMED Reiger Park ( Site 1910)

Boksburg, Gauteng, 1459, South Africa

Location

Midrand Medical Centre ( Site 1913)

Halfway House, Gauteng, 1685, South Africa

Location

Wits Health Consortium. Clinical HIV Research Unit ( Site 1923)

Johannesburg, Gauteng, 2041, South Africa

Location

Right To Care Research - Esizayo ( Site 1907)

Johannesburg, Gauteng, 2087, South Africa

Location

DJW Navorsing ( Site 1915)

Krugersdorp, Gauteng, 1739, South Africa

Location

Zinakekele Medical Centre ( Site 1926)

Moloto, Gauteng, 1022, South Africa

Location

Mzansi Ethical Research Centre ( Site 1918)

Mpumalanga, Gauteng, 1055, South Africa

Location

Global Clinical Trial Centre ( Site 1904)

Pretoria, Gauteng, 0186, South Africa

Location

Jongaie Research ( Site 1900)

Pretoria West, Gauteng, 0183, South Africa

Location

Dr Jugnundun & Partners ( Site 1905)

Durban, KwaZulu-Natal, 4091, South Africa

Location

Enhancing Care Foundation-DICRS ( Site 1922)

Durban, KwaZulu-Natal, 4091, South Africa

Location

Private Practice - Dr. Neyaseelan Gounden ( Site 1911)

Durban, KwaZulu-Natal, 4093, South Africa

Location

Limpopo Clinical Research Initiative ( Site 1901)

Thabazimbi, Limpopo, 0380, South Africa

Location

TASK Applied Science ( Site 1920)

Cape Town, Western Cape, 7405, South Africa

Location

DTHF Masiphumelele Clinical Research Site ( Site 1919)

Cape Town, Western Cape, 7975, South Africa

Location

Be Part Yoluntu Centre ( Site 1914)

Paarl, Western Cape, 7626, South Africa

Location

Paarl Research Centre ( Site 1924)

Paarl, Western Cape, 7646, South Africa

Location

Hospital Universitari Germans Trias i Pujol ( Site 2010)

Badalona, Barcelona, 08916, Spain

Location

CAP Centelles ( Site 2011)

Centelles, Barcelona, 08540, Spain

Location

Hospital de Alcorcon ( Site 2003)

Alcorcón, Madrid, Comunidad de, 28922, Spain

Location

C.S. Vallcarca-Sant Gervasi ( Site 2000)

Barcelona, 08023, Spain

Location

CAP de Sardenya ( Site 2009)

Barcelona, 08025, Spain

Location

Hospital Universitario Infanta Leonor ( Site 2002)

Madrid, 28031, Spain

Location

Hospital Universitario La Paz ( Site 2024)

Madrid, 28046, Spain

Location

HIV-NAT AIDS Research Centre ( Site 2804)

Bangkok, Bangkok, 10330, Thailand

Location

Chulabhorn Hospital ( Site 2801)

Lak Si, Bangkok, 10210, Thailand

Location

Rajavithi Hospital ( Site 2803)

Ratchathewi, Bangkok, 10400, Thailand

Location

The Golden Jubilee Medical Center ( Site 2800)

Phutthamonthon, Changwat Nakhon Pathom, 73170, Thailand

Location

Songklanagarind Hospital ( Site 2802)

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Atakent Acibadem Hastanesi ( Site 2103)

Halkali/K.cekmece, Istanbul, 34303, Turkey (Türkiye)

Location

Ankara Universitesi Ibni Sina Hastanesi ( Site 2101)

Ankara, 06230, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi ( Site 2102)

Ankara, 06230, Turkey (Türkiye)

Location

Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2106)

Ankara, 06560, Turkey (Türkiye)

Location

Ankara Sehir Hastanesi ( Site 2111)

Ankara, 06800, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi ( Site 2110)

Istanbul, 34093, Turkey (Türkiye)

Location

Medipol Universite Hastanesi ( Site 2108)

Istanbul, 34214, Turkey (Türkiye)

Location

Basaksehir Cam ve Sakura City Hospital ( Site 2112)

Istanbul, 34494, Turkey (Türkiye)

Location

Sancaktepe Prof Dr Ilhan Varank EAH-Prof Dr Feriha Oz Hastanesi ( Site 2113)

Istanbul, 34785, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi ( Site 2105)

Izmir, 35100, Turkey (Türkiye)

Location

Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2107)

Sakarya, 54100, Turkey (Türkiye)

Location

Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 2232)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76007, Ukraine

Location

Regional Phthisiopulmonological Center ( Site 2203)

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

Location

NPME -Central Clinical Hospital of Ivano-Frankivsk City Council ( Site 2204)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76025, Ukraine

Location

Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 2229)

Kharkiv, Kharkivs’ka Oblast’, 61002, Ukraine

Location

PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 2201)

Kharkiv, Kharkivs’ka Oblast’, 61172, Ukraine

Location

Limited Liability Company Medical center Healthy Happy ( Site 2225)

Kyiv, Kyivska Oblast, 01033, Ukraine

Location

MNPE Consultative-Diagnostic Centre of Desnyanskyi District of Kyiv ( Site 2205)

Kyiv, Kyivska Oblast, 02232, Ukraine

Location

Kyiv railway clinical hospital 2 of Branch Health center ( Site 2207)

Kyiv, Kyivska Oblast, 03049, Ukraine

Location

Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 2200)

Lviv, Lviv Oblast, 79011, Ukraine

Location

Odesa Regional Center of Socially Significant Diseases ( Site 2230)

Odesa, Odesa Oblast, 65014, Ukraine

Location

MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 2226)

Odesa, Odesa Oblast, 65025, Ukraine

Location

Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 2227)

Poltava, Poltava Oblast, 36011, Ukraine

Location

Medical Clinical Investigational Center of Medical Center Health Clinic ( Site 2210)

Vinnytsia, Vinnytsia Oblast, 21009, Ukraine

Location

Related Publications (1)

• Alpizar SA, Accini J, Anderson DC, Eysa B, Medina-Pinon I, Ohmagari N, Ostrovskyy MM, Aggrey-Amable A, Beck K, Byrne D, Grayson S, Hwang PMT, Lonchar JD, Strizki J, Xu Y, Paschke A, De Anda CS, Sears PS; MOVe-AHEAD study group. Molnupiravir for intra-household prevention of COVID-19: The MOVe-AHEAD randomized, placebo-controlled trial. J Infect. 2023 Nov;87(5):392-402. doi: 10.1016/j.jinf.2023.08.016. Epub 2023 Sep 9.

  PMID: 37690669 RESULT

Related Links

• Merck Clinical Trials Information
• 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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: June 25, 2021
• Study Start: August 11, 2021
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: September 26, 2024
• Results First Posted: February 6, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

ZA (18); GU (5); RU (16); KE (3); EG (6); JP (8); ES (7); HU (8); ME (13); TU (11); PH (3); BR (7); AR (8); US (59); TH (5); DO (1); MY (2); FR (5); BU (3); CO (10); PE (7); UA (13); RO (8)