AzTrials
AzTrials

Coronavirus Disease (COVID-19)Phase 3MOVe-AHEADNCT04939428

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

A Phase 3 study testing Molnupiravir in people with Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 226 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Coronavirus Disease (COVID-19)
What is being tested?
Molnupiravir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,441 participants
Where
226 sitesin 23 countries
Study dates
11 Aug 2021to 16 Nov 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

226 sites in 23 countries.

226 sites in 23 countries

United States59 sites

  • PharmaTex Research, LLC ( Site 2541)

    Amarillo, Texas, 79109

  • Institute of Human Virology ( Site 2504)

    Baltimore, Maryland, 21201

  • Cahaba Research, Inc. ( Site 2523)

    Birmingham, Alabama, 35235

  • TTS Research ( Site 2433)

    Boerne, Texas, 78006

  • Synergy Healthcare ( Site 2521)

    Bradenton, Florida, 34208

  • Mercury Street Medical Group PLLC ( Site 2476)

    Butte, Montana, 59701

  • Hope Clinical Research ( Site 2400)

    Canoga Park, California, 91303

  • Carbon Health ( Site 2515)

    Carlsbad, California, 92009

  • Chicago Clinical Research Institute Inc ( Site 2454)

    Chicago, Illinois, 60607

  • Rush University Medical Center ( Site 2510)

    Chicago, Illinois, 60612

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

    Cincinnati, Ohio, 45219

  • Future Innovative Treatments, LLC ( Site 2471)

    Colorado Springs, Colorado, 80907

  • University of Missouri Hospital ( Site 2486)

    Columbia, Missouri, 65201

  • Dayton Clinical Research ( Site 2488)

    Dayton, Ohio, 45406

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

    DeLand, Florida, 32720

  • Velocity Clinical Research-Providence ( Site 2432)

    East Greenwich, Rhode Island, 02818

  • Centennial Medical Group ( Site 2435)

    Elkridge, Maryland, 21075

  • Michigan Center of Medical Research ( Site 2445)

    Farmington Hills, Michigan, 48334

  • Prime Health and Wellness/SKYCRNG ( Site 2538)

    Fayette, Mississippi, 39069

  • UCSF Fresno ( Site 2528)

    Fresno, California, 93701

  • ASCADA Research, LLC ( Site 2516)

    Fullerton, California, 92835

  • ECU Adult Specialty Care ( Site 2415)

    Greenville, North Carolina, 27834

  • Tribe Clinical Research, LLC ( Site 2409)

    Greenville, South Carolina, 29607

  • Velocity Clinical Research, Hallandale Beach ( Site 2485)

    Hallandale, Florida, 33009

  • Indago Research and Health Center Inc ( Site 2412)

    Hialeah, Florida, 33012

  • ID Care ( Site 2466)

    Hillsborough, New Jersey, 08844

  • Houston Methodist Hospital ( Site 2463)

    Houston, Texas, 77030

  • Santa Clara Family Clinic ( Site 2462)

    Houston, Texas, 77087

  • Marvel Clinical Research ( Site 2490)

    Huntington Beach, California, 92647

  • Advanced Research For Health Improvement LLC ( Site 2436)

    Immokalee, Florida, 34142

  • Excel Clinical Research, LLC ( Site 2404)

    Las Vegas, Nevada, 89109

  • Michigan Center of Medical Research ( Site 2525)

    Lathrup Village, Michigan, 48076

  • Balanced Life Healthcare Solutions/SKYCRNG ( Site 2539)

    Lawrenceville, Georgia, 30046

  • National Research Institute ( Site 2452)

    Los Angeles, California, 90057

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

    Mesa, Arizona, 85210

  • Southern Clinical Research Associates ( Site 2542)

    Metairie, Louisiana, 70001

  • MedPharmics, LLC ( Site 2443)

    Metairie, Louisiana, 70006

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

    Miami, Florida, 33186

  • Allina Health Infectious Diseases Research Clinic ( Site 2507)

    Minneapolis, Minnesota, 55404

  • Valley Clinical Trials Inc. ( Site 2406)

    Northridge, California, 91325

  • Carbon Health ( Site 2514)

    Oakland, California, 94610

  • University of Nebraska Medical Center ( Site 2430)

    Omaha, Nebraska, 68198-3135

  • Preferred Clinical Research ( Site 2470)

    Pittsburgh, Pennsylvania, 15236

  • CDC Research Institute, LLC ( Site 2540)

    Port Saint Lucie, Florida, 34952

  • Amici Clinical Research LLC ( Site 2426)

    Raritan, New Jersey, 08869

  • Quinn Healthcare/Skycrng ( Site 2537)

    Ridgeland, Mississippi, 39157

  • University of California Davis ( Site 2497)

    Sacramento, California, 95817

  • AXCES Research Group ( Site 2437)

    Santa Fe, New Mexico, 87505

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

    Seattle, Washington, 98109

  • Jadestone Clinical Research, LLC ( Site 2530)

    Silver Spring, Maryland, 20904

  • Millennium Clinical Trials ( Site 2468)

    Simi Valley, California, 93065

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

    Tahlequah, Oklahoma, 74464

  • Clinical Research Trials of Florida ( Site 2402)

    Tampa, Florida, 33607

  • Montefiore Medical Center ( Site 2503)

    The Bronx, New York, 10462

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

    Tucson, Arizona, 85712

  • Crossroads Clinical Research LLC ( Site 2451)

    Victoria, Texas, 77901

  • Emerson Clinical Research Institute ( Site 2457)

    Washington D.C., District of Columbia, 20011

  • TPMG Clinical Research ( Site 2495)

    Williamsburg, Virginia, 23188

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

    Winter Park, Florida, 32789

Other trials in United States

South Africa18 sites

  • IATROS International ( Site 1921)

    Bloemfontein, Free State, 9300

  • REIMED Reiger Park ( Site 1910)

    Boksburg, Gauteng, 1459

  • TASK Applied Science ( Site 1920)

    Cape Town, Western Cape, 7405

  • DTHF Masiphumelele Clinical Research Site ( Site 1919)

    Cape Town, Western Cape, 7975

  • Dr Jugnundun & Partners ( Site 1905)

    Durban, KwaZulu-Natal, 4091

  • Enhancing Care Foundation-DICRS ( Site 1922)

    Durban, KwaZulu-Natal, 4091

  • Private Practice - Dr. Neyaseelan Gounden ( Site 1911)

    Durban, KwaZulu-Natal, 4093

  • Midrand Medical Centre ( Site 1913)

    Halfway House, Gauteng, 1685

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

    Johannesburg, Gauteng, 2041

  • Right To Care Research - Esizayo ( Site 1907)

    Johannesburg, Gauteng, 2087

  • DJW Navorsing ( Site 1915)

    Krugersdorp, Gauteng, 1739

  • Zinakekele Medical Centre ( Site 1926)

    Moloto, Gauteng, 1022

  • Mzansi Ethical Research Centre ( Site 1918)

    Mpumalanga, Gauteng, 1055

  • Be Part Yoluntu Centre ( Site 1914)

    Paarl, Western Cape, 7626

  • Paarl Research Centre ( Site 1924)

    Paarl, Western Cape, 7646

  • Global Clinical Trial Centre ( Site 1904)

    Pretoria, Gauteng, 0186

  • Jongaie Research ( Site 1900)

    Pretoria West, Gauteng, 0183

  • Limpopo Clinical Research Initiative ( Site 1901)

    Thabazimbi, Limpopo, 0380

Other trials in South Africa

Russia16 sites

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

    Kazan', Tatarstan, Respublika, 420140

  • FSBI Central Hospital with Policlinics ( Site 1807)

    Moscow, Moscow, 121359

  • Infectious Clinical Hospital # 1 ( Site 1834)

    Moscow, Moscow, 125310

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

    Saint Petersburg, Sankt-Peterburg, 192071

  • SPb SBHI City outpatient clinic 112 ( Site 1829)

    Saint Petersburg, Sankt-Peterburg, 195427

  • Medical Research Institute LLC. ( Site 1814)

    Saint Petersburg, Sankt-Peterburg, 196084

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

    Saint Petersburg, Sankt-Peterburg, 196143

  • Smorodintsev Research Institute of Influenza ( Site 1833)

    Saint Petersburg, Sankt-Peterburg, 197376

  • City Polyclinic #88 ( Site 1808)

    Saint Petersburg, Sankt-Peterburg, 198261

  • Nikolaevskaya hospital ( Site 1810)

    Saint Petersburg, Sankt-Peterburg, 198510

  • SPb SBHI City outpatient clinic 4 ( Site 1831)

    Saint Petersburg, Sankt-Peterburg, 199406

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

    Saint-Petrsburg, Sankt-Peterburg, 190013

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

    Saint-Petrsburg, Sankt-Peterburg, 192289

  • Smolensk State Medical Academy ( Site 1803)

    Smolensk, Smolensk Oblast, 214019

  • Voronezh Regional Clinical Hospital #1 ( Site 1823)

    Voronezh, Voronezskaja Oblast, 394066

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

    Yaroslavl, Yaroslavl Oblast, 150001

Other trials in Russia

Mexico13 sites

  • Hospital General de Acapulco ( Site 1319)

    Acapulco de Juárez, Guerrero, 39570

  • Centro de Investigacion Medica Aguascalientes ( Site 1305)

    Aguascalientes, 20116

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

    Cancún, Quintana Roo, 77500

  • ICARO Investigaciones en Medicina ( Site 1313)

    Chihuahua City, 31000

  • Centro Médico Universitario ( Site 1316)

    Cuernavaca, Morelos, 62210

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

    General Escobedo, Nuevo León, 66055

  • Instituto Jalisciense de Metabolismo SC ( Site 1314)

    Guadalajara, Jalisco, 44670

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

    León, Guanajuato, 37000

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

    Mérida, Yucatán, 97070

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

    Mexico City, Mexico City, 14080

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

    Mexico City, 14050

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

    Oaxaca City, 68000

  • Arké SMO S.A de C.V ( Site 1306)

    Veracruz, 91910

Other trials in Mexico

Ukraine13 sites

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

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76007

  • Regional Phthisiopulmonological Center ( Site 2203)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

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

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76025

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

    Kharkiv, Kharkiv Oblast, 61002

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

    Kharkiv, Kharkiv Oblast, 61172

  • Limited Liability Company Medical center Healthy Happy ( Site 2225)

    Kyiv, Kyivska Oblast, 01033

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

    Kyiv, Kyivska Oblast, 02232

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

    Kyiv, Kyivska Oblast, 03049

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

    Lviv, Lviv Oblast, 79011

  • Odesa Regional Center of Socially Significant Diseases ( Site 2230)

    Odesa, Odesa Oblast, 65014

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

    Odesa, Odesa Oblast, 65025

  • Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 2227)

    Poltava, Poltava Oblast, 36011

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

    Vinnytsia, Vinnytsia Oblast, 21009

Other trials in Ukraine

Turkey (Türkiye)11 sites

  • Ankara Universitesi Ibni Sina Hastanesi ( Site 2101)

    Ankara, 06230

  • Hacettepe Universitesi Tip Fakultesi ( Site 2102)

    Ankara, 06230

  • Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2106)

    Ankara, 06560

  • Ankara Sehir Hastanesi ( Site 2111)

    Ankara, 06800

  • Atakent Acibadem Hastanesi ( Site 2103)

    Halkali/K.cekmece, Istanbul, 34303

  • Istanbul Universitesi Istanbul Tip Fakultesi ( Site 2110)

    Istanbul, 34093

  • Medipol Universite Hastanesi ( Site 2108)

    Istanbul, 34214

  • Basaksehir Cam ve Sakura City Hospital ( Site 2112)

    Istanbul, 34494

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

    Istanbul, 34785

  • Ege Universitesi Tip Fakultesi Hastanesi ( Site 2105)

    Izmir, 35100

  • Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2107)

    Sakarya, 54100

Other trials in Turkey (Türkiye)

Colombia10 sites

  • Centro Cientifico Asistencial Jose Luis Accini ( Site 0412)

    Barranquilla, Atlántico, 080020

  • Clinica de la Costa Ltda. ( Site 0407)

    Barranquilla, Atlántico, 080020

  • Hospital Universitario Clinica San Rafael ( Site 0410)

    Bogota, Cundinamarca, 110411

  • Caja de Compensacion Familiar CAFAM ( Site 0403)

    Bogotá, Bogota D.C., 111211

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

    Bucaramanga, Santander Department, 681004

  • Fundacion Valle del Lili ( Site 0405)

    Cali, Valle del Cauca Department, 760032

  • Fundacion Centro de Investigacion Clinica CIC ( Site 0402)

    Medellín, Antioquia, 050021

  • Oncomedica S.A. ( Site 0406)

    Montería, Departamento de Córdoba, 230002

  • Fundacion Centro de Investigaciones Clinicas CARDIOMET ( Site 0409)

    Pereira, Risaralda Department, 660003

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

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Argentina8 sites

  • CEMIC ( Site 0101)

    Buenos Aires, C1431FWO

  • Mautalen Salud e Investigacion ( Site 0103)

    Caba, Buenos Aires, C1128AAF

  • Sanatorio de la Trinidad Mitre ( Site 0108)

    CABA, Buenos Aires, C1039AAO

  • Hospital Italiano de Buenos Aires ( Site 0102)

    CABA, Buenos Aires, C1199ABB

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0105)

    Mar del Plata, Buenos Aires, B7600FZO

  • Clinica Independencia ( Site 0104)

    Munro, Buenos Aires, B1605FRE

  • Instituto Medico de la Fundacion Estudios Clinicos ( Site 0106)

    Rosario, Santa Fe Province, 2000

  • Grupo Oroño Centro medico San Nicolas ( Site 0109)

    San Nicolás de los Arroyos, Buenos Aires, B2900DPA

Other trials in Argentina

Hungary8 sites

  • DRC Gyogyszervizsgalo Kozpont Kft. ( Site 0801)

    Balatonfüred, Veszprém megye, 8230

  • Obudai Egeszsegugyi Centrum - OEC ( Site 0821)

    Budapest, 1036

  • Strazsahegy Medicina Bt ( Site 0823)

    Budapest, 1171

  • Debreceni Egyetem Klinikai Kozpont- Infektologiai Klinika ( Site 0824)

    Debrecen, Hajdú-Bihar, 4031

  • Bugat Pal Korhaz ( Site 0817)

    Gyöngyös, Heves County, 3200

  • Medifarma-98 Kft. ( Site 0808)

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • LONA MEDIC Kft ( Site 0804)

    Orosháza, Bekes County, 5900

  • Obudai Egeszsegugyi Centrum - Zalaegerszeg ( Site 0819)

    Zalaegerszeg, 8900

Other trials in Hungary

Japan8 sites

  • Chiba Aoba Municipal Hospital ( Site 1100)

    Chiba, 260-0852

  • National Hospital Organization Okinawa National Hospital ( Site 1109)

    Ginowan, Okinawa, 901-2214

  • IUHW Narita Hospital ( Site 1105)

    Narita, Chiba, 286-8520

  • Global Healthcare Clinic ( Site 1106)

    Tokyo, 102-0083

  • Den-en-chofu family clinic ( Site 1104)

    Tokyo, 145-0071

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

    Tokyo, 162-8655

  • Sekino Hospital ( Site 1110)

    Tokyo, 171-0014

  • Social Medical Corporation Yuuaikai Yuuai Medical Center ( Site 1108)

    Tomigusuku, Okinawa, 901-0224

Other trials in Japan

Romania8 sites

  • Centrul Medical Unirea ( Site 1705)

    Brasov, 500091

  • Centrul Medical Unirea SRL Bucuresti ( Site 1706)

    Bucharest, 011601

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

    Bucharest, 014142

  • SC Policlinica CCBR SRL. Bucuresti ( Site 1704)

    Bucharest, 030463

  • Centrul Medical Unirea SRL ( Site 1707)

    Cluj-Napoca, Cluj, 400349

  • Centrul Medical Unirea SRL Constanta ( Site 1703)

    Constanța, 900540

  • Centrul Medical Unirea SRL IASI ( Site 1701)

    Iași, 700023

  • S.C Materna Care SRL ( Site 1702)

    Timișoara, Timiș County, 300645

Other trials in Romania

Brazil7 sites

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

    Campo Grande, Mato Grosso do Sul, 79070-900

  • Hospital Nossa Senhora das Gracas ( Site 0310)

    Curitiba, Paraná, 80810-040

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

    Ijuí, Rio Grande do Sul, 98700-000

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

    Manaus, Amazonas, 69040-000

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

    Rio de Janeiro, 22780-192

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

    São José do Rio Preto, São Paulo, 15090000

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

    São Paulo, 04121-000

Other trials in Brazil

Peru7 sites

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

    La Perla, Qallaw, 07011

  • Clínica Ricardo Palma ( Site 1406)

    Lima, 15036

  • Asociacion Civil por la Salud ( Site 1411)

    Lima, 15046

  • Investigaciones Medicas en Salud - INMENSA ( Site 1401)

    Lima, 15046

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

    Lima, 15088

  • Clinica Providencia ( Site 1400)

    Lima, 15088

  • Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1404)

    Lima, 15423

Other trials in Peru

Spain7 sites

  • Hospital de Alcorcon ( Site 2003)

    Alcorcón, Madrid, Comunidad de, 28922

  • Hospital Universitari Germans Trias i Pujol ( Site 2010)

    Badalona, Barcelona, 08916

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

    Barcelona, 08023

  • CAP de Sardenya ( Site 2009)

    Barcelona, 08025

  • CAP Centelles ( Site 2011)

    Centelles, Barcelona, 08540

  • Hospital Universitario Infanta Leonor ( Site 2002)

    Madrid, 28031

  • Hospital Universitario La Paz ( Site 2024)

    Madrid, 28046

Other trials in Spain

Egypt6 sites

  • Masri - CRC - Ain Shams University ( Site 2900)

    Cairo, Cairo Governorate, 11566

  • Masri - CRC - Ain Shams University ( Site 2910)

    Cairo, Cairo Governorate, 11566

  • National Hepatology and Tropical Medicine Research Institute ( Site 2930)

    Cairo, Cairo Governorate, 11796

  • Air Force Specialized Hospital Clinical Research Center ( Site 2920)

    Cairo, Cairo Governorate, 11835

  • National Center for allergies and chest ( Site 2940)

    Giza, Giza Governorate, 12651

  • Imbaba Fevers Hospital ( Site 2945)

    Giza, Giza Governorate, 12661

Other trials in Egypt

France5 sites

  • CHU Martinique ( Site 0511)

    Fort-de-France, Martinique, 97200

  • Maison de santé du Pays Neufchatelois ( Site 0507)

    Neufchâtel-en-Bray, Seine-Maritime, 76270

  • Hôpital Pitié - Salpêtrière ( Site 0501)

    Paris, Île-de-France Region, 75013

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

    Saint-Pierre, La Reunion, 97448

  • Maison de Sante Universitaire La Providence ( Site 0506)

    Toulouse, Haute-Garonne, 31500

Other trials in France

Guatemala5 sites

  • Centro de Investigaciones Pediatricas ( Site 0703)

    Guatemala City, 01001

  • Unidad de Diagnostico Cardiologico ( Site 0701)

    Guatemala City, 01001

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

    Guatemala City, 01009

  • Clinica Privada ( Site 0705)

    Guatemala City, 01010

  • Private Clinic - Dr. Hugo Pezzarossi ( Site 0704)

    Guatemala City, 01015

Other trials in Guatemala

Thailand5 sites

  • HIV-NAT AIDS Research Centre ( Site 2804)

    Bangkok, Bangkok, 10330

  • Songklanagarind Hospital ( Site 2802)

    Hat Yai, Changwat Songkhla, 90110

  • Chulabhorn Hospital ( Site 2801)

    Lak Si, Bangkok, 10210

  • The Golden Jubilee Medical Center ( Site 2800)

    Phutthamonthon, Changwat Nakhon Pathom, 73170

  • Rajavithi Hospital ( Site 2803)

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

Bulgaria3 sites

  • Medical Center Hera Kyustendi EOOD ( Site 3003)

    Kyustendil, 2500

  • Medical Center Hera EOOD - Montana branch ( Site 3002)

    Montana, 3400

  • Medical Center Hera EOOD ( Site 3001)

    Sofia, Sofia (stolitsa), 1510

Other trials in Bulgaria

Kenya3 sites

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

    Kisumu, 40100

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

    Nairobi, Nairobi City, 00200

  • Partners in Health Research and Development PHRD ( Site 1928)

    Nairobi, Nairobi City, 00202

Other trials in Kenya

Philippines3 sites

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

    Cavite, 4102

  • Asian Hospital and Medical Center ( Site 1503)

    Muntinlupa, National Capital Region, 1780

  • Quirino Memorial Medical Center ( Site 1501)

    Quezon City, National Capital Region, 1109

Other trials in Philippines

Malaysia2 sites

  • Hospital Raja Perempuan Zainab II ( Site 2851)

    Kota Bharu, Kelantan, 15586

  • Klinik Kesihatan Masjid Tanah ( Site 2850)

    Masjid Tanah, Melaka, 78300

Other trials in Malaysia

Dominican Republic1 site

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

    Santo Domingo, Nacional, 10605

Other trials in Dominican Republic

About this study

Official title: 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.

Being tested
Molnupiravir, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MolnupiravirDrug

    Also called MK-4482

    Four molnupiravir 200 mg capsules taken by mouth.

  • PlaceboDrug

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

Study groups in NCT04939428
Study groupRoleWhat they receive
MolnupiravirExperimentalParticipants take molnupiravir 800 mg every 12 hours (Q12H) on Days 1 to 5.
Receives: Drug: Molnupiravir
PlaceboPlacebo comparatorParticipants take placebo Q12H on Days 1 to 5.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 14

  2. 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.

    Measured: 29 days

  3. 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.

    Measured: Up to 5 days

Secondary outcomes (4)

  1. 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

    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.

    Measured: Up to Day 14

  2. 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

    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.

    Measured: Up to Day 29

  3. 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

    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.

    Measured: Up to Day 14

  4. 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

    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.

    Measured: Up to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study start11 Aug 2021
  3. Primary completion16 Nov 2022
  4. Study completion16 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
2,441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939428
Sponsor's protocol ID
4482-013
Other IDs
MK-4482-013, jRCT2031210281, PHRR211007-003980, 2021-000904-39
Acronym
MOVe-AHEAD
Status last verified
Sep 2024
First submitted
24 Jun 2021
Last updated
26 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 37690669

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Molnupiravir in people with Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 226 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, South Africa, Russia, Mexico, Ukraine and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04939428, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.

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