Clinical trial NCT04939428: Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronavirus Disease (COVID-19)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-06-25
Enrollment: 2441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Day 14
measure: Percentage of Participants With ≥1 Adverse Event
timeFrame: 29 days
measure: Percentage of Participants Discontinuing From Study Therapy Due to AE
timeFrame: Up to 5 days
Secondary outcomes:
measure: 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
timeFrame: Up to Day 14
measure: 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
timeFrame: Up to Day 29
measure: 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
timeFrame: Up to Day 14
measure: 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
timeFrame: Up to Day 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Research, Inc. ( Site 2523)
state: Alabama
city: Mesa
country: United States
facility: The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2484)
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2448)
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research ( Site 2400)
state: California
city: Carlsbad
country: United States
facility: Carbon Health ( Site 2515)
state: California
city: Fresno
country: United States
facility: UCSF Fresno ( Site 2528)
state: California
city: Fullerton
country: United States
facility: ASCADA Research, LLC ( Site 2516)
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research ( Site 2490)
state: California
city: Los Angeles
country: United States
facility: National Research Institute ( Site 2452)
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials Inc. ( Site 2406)
state: California
city: Oakland
country: United States
facility: Carbon Health ( Site 2514)
state: California
city: Sacramento
country: United States
facility: University of California Davis ( Site 2497)
state: California
city: Simi Valley
country: United States
facility: Millennium Clinical Trials ( Site 2468)
state: California
city: Colorado Springs
country: United States
facility: Future Innovative Treatments, LLC ( Site 2471)
state: Colorado
city: Washington
country: United States
facility: Emerson Clinical Research Institute ( Site 2457)
state: District of Columbia
city: Bradenton
country: United States
facility: Synergy Healthcare ( Site 2521)
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites-DeLand Clinical Research Unit ( Site 2535)
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 2485)
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center Inc ( Site 2412)
state: Florida
city: Immokalee
country: United States
facility: Advanced Research For Health Improvement LLC ( Site 2436)
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2508)
state: Florida
city: Port Saint Lucie
country: United States
facility: CDC Research Institute, LLC ( Site 2540)
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida ( Site 2402)
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2425)
state: Florida
city: Lawrenceville
country: United States
facility: Balanced Life Healthcare Solutions/SKYCRNG ( Site 2539)
state: Georgia
city: Chicago
country: United States
facility: Chicago Clinical Research Institute Inc ( Site 2454)
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center ( Site 2510)
state: Illinois
city: Metairie
country: United States
facility: Southern Clinical Research Associates ( Site 2542)
state: Louisiana
city: Metairie
country: United States
facility: MedPharmics, LLC ( Site 2443)
state: Louisiana
city: Baltimore
country: United States
facility: Institute of Human Virology ( Site 2504)
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Group ( Site 2435)
state: Maryland
city: Silver Spring
country: United States
facility: Jadestone Clinical Research, LLC ( Site 2530)
state: Maryland
city: Farmington Hills
country: United States
facility: Michigan Center of Medical Research ( Site 2445)
state: Michigan
city: Lathrup Village
country: United States
facility: Michigan Center of Medical Research ( Site 2525)
state: Michigan
city: Minneapolis
country: United States
facility: Allina Health Infectious Diseases Research Clinic ( Site 2507)
state: Minnesota
city: Fayette
country: United States
facility: Prime Health and Wellness/SKYCRNG ( Site 2538)
state: Mississippi
city: Ridgeland
country: United States
facility: Quinn Healthcare/Skycrng ( Site 2537)
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri Hospital ( Site 2486)
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group PLLC ( Site 2476)
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center ( Site 2430)
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC ( Site 2404)
state: Nevada
city: Hillsborough
country: United States
facility: ID Care ( Site 2466)
state: New Jersey
city: Raritan
country: United States
facility: Amici Clinical Research LLC ( Site 2426)
state: New Jersey
city: Santa Fe
country: United States
facility: AXCES Research Group ( Site 2437)
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center ( Site 2503)
state: New York
city: Greenville
country: United States
facility: ECU Adult Specialty Care ( Site 2415)
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 2517)
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research ( Site 2488)
state: Ohio
city: Tahlequah
country: United States
facility: Cherokee Nation WW Hastings Indian Hospital/Cherokee Nation Health Services ( Site 2459)
state: Oklahoma
city: Pittsburgh
country: United States
facility: Preferred Clinical Research ( Site 2470)
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research-Providence ( Site 2432)
state: Rhode Island
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC ( Site 2409)
state: South Carolina
city: Amarillo
country: United States
facility: PharmaTex Research, LLC ( Site 2541)
state: Texas
city: Boerne
country: United States
facility: TTS Research ( Site 2433)
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital ( Site 2463)
state: Texas
city: Houston
country: United States
facility: Santa Clara Family Clinic ( Site 2462)
state: Texas
city: Victoria
country: United States
facility: Crossroads Clinical Research LLC ( Site 2451)
state: Texas
city: Williamsburg
country: United States
facility: TPMG Clinical Research ( Site 2495)
state: Virginia
city: Seattle
country: United States
facility: Covid-19 Clinical Research Center (CCRC) ( Site 2421)
state: Washington
city: Caba
country: Argentina
facility: Sanatorio de la Trinidad Mitre ( Site 0108)
state: Buenos Aires
city: Caba
country: Argentina
facility: Mautalen Salud e Investigacion ( Site 0103)
state: Buenos Aires
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires ( Site 0102)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0105)
state: Buenos Aires
city: Munro
country: Argentina
facility: Clinica Independencia ( Site 0104)
state: Buenos Aires
city: San Nicolas
country: Argentina
facility: Grupo Oroño Centro medico San Nicolas ( Site 0109)
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto Medico de la Fundacion Estudios Clinicos ( Site 0106)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: CEMIC ( Site 0101)
city: Manaus
country: Brazil
facility: Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0303)
state: Amazonas
city: Campo Grande
country: Brazil
facility: Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul - UFMS ( Site 0305)
state: Mato Grosso Do Sul
city: Curitiba
country: Brazil
facility: Hospital Nossa Senhora das Gracas ( Site 0310)
state: Parana
city: Ijui
country: Brazil
facility: Oncosite-Centro de Pesquisa Clinica em Oncologia ( Site 0300)
state: Rio Grande Do Sul
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0312)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Centro de Referencia Professor Helio Fraga - FIOCRUZ/RJ ( Site 0314)
city: Sao Paulo
country: Brazil
facility: Centro de Referência e Treinamento DST/AIDS ( Site 0301)
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD ( Site 3001)
state: Sofia (stolitsa)
city: Kyustendil
country: Bulgaria
facility: Medical Center Hera Kyustendi EOOD ( Site 3003)
city: Montana
country: Bulgaria
facility: Medical Center Hera EOOD - Montana branch ( Site 3002)
city: Medellin
country: Colombia
facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0402)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Cientifico Asistencial Jose Luis Accini ( Site 0412)
state: Atlantico
city: Barranquilla
country: Colombia
facility: Clinica de la Costa Ltda. ( Site 0407)
state: Atlantico
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 0406)
state: Cordoba
city: Bogota
country: Colombia
facility: Hospital Universitario Clinica San Rafael ( Site 0410)
state: Cundinamarca
city: Zipaquira
country: Colombia
facility: Healthy Medical Center S.A.S ( Site 0413)
state: Cundinamarca
city: Bogota
country: Colombia
facility: Caja de Compensacion Familiar CAFAM ( Site 0403)
state: Distrito Capital De Bogota
city: Pereira
country: Colombia
facility: Fundacion Centro de Investigaciones Clinicas CARDIOMET ( Site 0409)
state: Risaralda
city: Bucaramanga
country: Colombia
facility: Instituto Neumologico del Oriente S.A. ( Site 0408)
state: Santander
city: Cali
country: Colombia
facility: Fundacion Valle del Lili ( Site 0405)
state: Valle Del Cauca
city: Santo Domingo
country: Dominican Republic
facility: Unidad de Aislamiento del Centro de Obstetricia y Ginecologia ( Site 2650)
state: Distrito Nacional
city: Giza
country: Egypt
facility: National Center for allergies and chest ( Site 2940)
state: Al Jizah
city: Giza
country: Egypt
facility: Imbaba Fevers Hospital ( Site 2945)
state: Al Jizah
city: Cairo
country: Egypt
facility: Masri - CRC - Ain Shams University ( Site 2900)
state: Al Qahirah
city: Cairo
country: Egypt
facility: Masri - CRC - Ain Shams University ( Site 2910)
state: Al Qahirah
city: Cairo
country: Egypt
facility: National Hepatology and Tropical Medicine Research Institute ( Site 2930)
state: Al Qahirah
city: Cairo
country: Egypt
facility: Air Force Specialized Hospital Clinical Research Center ( Site 2920)
state: Al Qahirah
city: Toulouse
country: France
facility: Maison de Sante Universitaire La Providence ( Site 0506)
state: Haute-Garonne
city: Paris
country: France
facility: Hôpital Pitié - Salpêtrière ( Site 0501)
state: Ile-de-France
city: Saint Pierre Cedex
country: France
facility: CHU de la Reunion - Groupe Hospitalier Sud ( Site 0508)
state: La Reunion
city: Fort-de-France
country: France
facility: CHU Martinique ( Site 0511)
state: Martinique
city: Neufchatel-en-Bray
country: France
facility: Maison de santé du Pays Neufchatelois ( Site 0507)
state: Seine-Maritime
city: Guatemala
country: Guatemala
facility: Centro de Investigaciones Pediatricas ( Site 0703)
city: Guatemala
country: Guatemala
facility: Unidad de Diagnostico Cardiologico ( Site 0701)
city: Guatemala
country: Guatemala
facility: Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0702)
city: Guatemala
country: Guatemala
facility: Clinica Privada ( Site 0705)
city: Guatemala
country: Guatemala
facility: Private Clinic - Dr. Hugo Pezzarossi ( Site 0704)
city: Oroshaza
country: Hungary
facility: LONA MEDIC Kft ( Site 0804)
state: Bekes
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont- Infektologiai Klinika ( Site 0824)
state: Hajdu-Bihar
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz ( Site 0817)
state: Heves
city: Nyiregyhaza
country: Hungary
facility: Medifarma-98 Kft. ( Site 0808)
state: Szabolcs-Szatmar-Bereg
city: Balatonfured
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Kft. ( Site 0801)
state: Veszprem
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum - OEC ( Site 0821)
city: Budapest
country: Hungary
facility: Strazsahegy Medicina Bt ( Site 0823)
city: Zalaegerszeg
country: Hungary
facility: Obudai Egeszsegugyi Centrum - Zalaegerszeg ( Site 0819)
city: Narita
country: Japan
facility: IUHW Narita Hospital ( Site 1105)
state: Chiba
city: Ginowan
country: Japan
facility: National Hospital Organization Okinawa National Hospital ( Site 1109)
state: Okinawa
city: Tomigusuku
country: Japan
facility: Social Medical Corporation Yuuaikai Yuuai Medical Center ( Site 1108)
state: Okinawa
city: Chiba
country: Japan
facility: Chiba Aoba Municipal Hospital ( Site 1100)
city: Tokyo
country: Japan
facility: Global Healthcare Clinic ( Site 1106)
city: Tokyo
country: Japan
facility: Den-en-chofu family clinic ( Site 1104)
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine ( Site 1101)
city: Tokyo
country: Japan
facility: Sekino Hospital ( Site 1110)
city: Nairobi
country: Kenya
facility: Center for Clinical Research (CCR) KEMRI ( Site 1929)
state: Nairobi City
city: Nairobi
country: Kenya
facility: Partners in Health Research and Development PHRD ( Site 1928)
state: Nairobi City
city: Kisumu
country: Kenya
facility: KEMRI-CMR-RCTP- Kenya Medical Research Institute Kisumu ( Site 1925)
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II ( Site 2851)
state: Kelantan
city: Masjid Tanah
country: Malaysia
facility: Klinik Kesihatan Masjid Tanah ( Site 2850)
state: Melaka
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1308)
state: Distrito Federal
city: Leon
country: Mexico
facility: Morales Vargas Centro de Investigacion, S.C. ( Site 1318)
state: Guanajuato
city: Acapulco
country: Mexico
facility: Hospital General de Acapulco ( Site 1319)
state: Guerrero
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Metabolismo SC ( Site 1314)
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Centro Médico Universitario ( Site 1316)
state: Morelos
city: Gral Escobedo
country: Mexico
facility: CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 1315)
state: Nuevo Leon
city: Cancun
country: Mexico
facility: Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 1301)
state: Quintana Roo
city: Merida
country: Mexico
facility: Köhler & Milstein Research S.A. de C.V. ( Site 1300)
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Centro de Investigacion Medica Aguascalientes ( Site 1305)
city: Chihuahua
country: Mexico
facility: ICARO Investigaciones en Medicina ( Site 1313)
city: Mexico City
country: Mexico
facility: Medica Sur S.A.B de C.V. ( Site 1303)
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C. ( Site 1304)
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V ( Site 1306)
city: La Perla
country: Peru
facility: Policlínico Especializado en Neurología - Unid. Inv. Neurológica ( Site 1403)
state: Qallaw
city: Lima
country: Peru
facility: Clínica Ricardo Palma ( Site 1406)
city: Lima
country: Peru
facility: Asociacion Civil por la Salud ( Site 1411)
city: Lima
country: Peru
facility: Investigaciones Medicas en Salud - INMENSA ( Site 1401)
city: Lima
country: Peru
facility: Asociacion Civil IMPACTA Salud y Educacion - Sede San Miguel ( Site 1410)
city: Lima
country: Peru
facility: Clinica Providencia ( Site 1400)
city: Lima
country: Peru
facility: Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1404)
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center ( Site 1503)
state: National Capital Region
city: Quezon City
country: Philippines
facility: Quirino Memorial Medical Center ( Site 1501)
state: National Capital Region
city: Cavite
country: Philippines
facility: Health Index Multi-Specialty and Lying -in Clinic ( Site 1504)
city: Cluj-Napoca
country: Romania
facility: Centrul Medical Unirea SRL ( Site 1707)
state: Cluj
city: Timisoara
country: Romania
facility: S.C Materna Care SRL ( Site 1702)
state: Timis
city: Brasov
country: Romania
facility: Centrul Medical Unirea ( Site 1705)
city: Bucharest
country: Romania
facility: Centrul Medical Unirea SRL Bucuresti ( Site 1706)
city: Bucharest
country: Romania
facility: Delta Heath Care S.R.L ( Site 1708)
city: Bucharest
country: Romania
facility: SC Policlinica CCBR SRL. Bucuresti ( Site 1704)
city: Constanta
country: Romania
facility: Centrul Medical Unirea SRL Constanta ( Site 1703)
city: Iasi
country: Romania
facility: Centrul Medical Unirea SRL IASI ( Site 1701)
city: Moscow
country: Russian Federation
facility: FSBI Central Hospital with Policlinics ( Site 1807)
state: Moskva
city: Moscow
country: Russian Federation
facility: Infectious Clinical Hospital # 1 ( Site 1834)
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: SPb SBHI City outpatient clinic 112 ( Site 1829)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Smorodintsev Research Institute of Influenza ( Site 1833)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Nikolaevskaya hospital ( Site 1810)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: SPb SBHI City outpatient clinic 4 ( Site 1831)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Limited liability company "Scientific research center Eco-safety" ( Site 1809)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: City Polyclinic #88 ( Site 1808)
state: Sankt-Peterburg
city: Saint-Petrsburg
country: Russian Federation
facility: LLC -Medical Center . Capital-Polis ( Site 1825)
state: Sankt-Peterburg
city: Saint-Petrsburg
country: Russian Federation
facility: St.Petersburg Outpatient Clinic No. 109 ( Site 1818)
state: Sankt-Peterburg
city: St.Petersburg
country: Russian Federation
facility: SPb SBHI. City outpatient clinic No.44 ( Site 1830)
state: Sankt-Peterburg
city: St.Petersburg
country: Russian Federation
facility: Medical Research Institute LLC. ( Site 1814)
state: Sankt-Peterburg
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy ( Site 1803)
state: Smolenskaya Oblast
city: Kazan
country: Russian Federation
facility: Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1802)
state: Tatarstan, Respublika
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hospital #1 ( Site 1823)
state: Voronezskaja Oblast
city: Yaroslavl
country: Russian Federation
facility: LLC -Clinic of modern medicine of Doctor Bogorodskaya ( Site 1828)
state: Yaroslavskaya Oblast
city: Bloemfontein
country: South Africa
facility: IATROS International ( Site 1921)
state: Free State
city: Boksburg
country: South Africa
facility: REIMED Reiger Park ( Site 1910)
state: Gauteng
city: Halfway House
country: South Africa
facility: Midrand Medical Centre ( Site 1913)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Health Consortium. Clinical HIV Research Unit ( Site 1923)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Right To Care Research - Esizayo ( Site 1907)
state: Gauteng
city: Krugersdorp
country: South Africa
facility: DJW Navorsing ( Site 1915)
state: Gauteng
city: Moloto
country: South Africa
facility: Zinakekele Medical Centre ( Site 1926)
state: Gauteng
city: Mpumalanga
country: South Africa
facility: Mzansi Ethical Research Centre ( Site 1918)
state: Gauteng
city: Pretoria-West
country: South Africa
facility: Jongaie Research ( Site 1900)
state: Gauteng
city: Pretoria
country: South Africa
facility: Global Clinical Trial Centre ( Site 1904)
state: Gauteng
city: Durban
country: South Africa
facility: Dr Jugnundun & Partners ( Site 1905)
state: Kwazulu-Natal
city: Durban
country: South Africa
facility: Enhancing Care Foundation-DICRS ( Site 1922)
state: Kwazulu-Natal
city: Durban
country: South Africa
facility: Private Practice - Dr. Neyaseelan Gounden ( Site 1911)
state: Kwazulu-Natal
city: Thabazimbi
country: South Africa
facility: Limpopo Clinical Research Initiative ( Site 1901)
state: Limpopo
city: Cape Town
country: South Africa
facility: TASK Applied Science ( Site 1920)
state: Western Cape
city: Cape Town
country: South Africa
facility: DTHF Masiphumelele Clinical Research Site ( Site 1919)
state: Western Cape
city: Paarl
country: South Africa
facility: Be Part Yoluntu Centre ( Site 1914)
state: Western Cape
city: Paarl
country: South Africa
facility: Paarl Research Centre ( Site 1924)
state: Western Cape
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol ( Site 2010)
state: Barcelona
city: Centelles
country: Spain
facility: CAP Centelles ( Site 2011)
state: Barcelona
city: Alcorcon
country: Spain
facility: Hospital de Alcorcon ( Site 2003)
state: Madrid, Comunidad De
city: Barcelona
country: Spain
facility: C.S. Vallcarca-Sant Gervasi ( Site 2000)
city: Barcelona
country: Spain
facility: CAP de Sardenya ( Site 2009)
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor ( Site 2002)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 2024)
city: Bangkok
country: Thailand
facility: HIV-NAT AIDS Research Centre ( Site 2804)
state: Krung Thep Maha Nakhon
city: Lak Si
country: Thailand
facility: Chulabhorn Hospital ( Site 2801)
state: Krung Thep Maha Nakhon
city: Ratchathewi
country: Thailand
facility: Rajavithi Hospital ( Site 2803)
state: Krung Thep Maha Nakhon
city: Phutthamonthon
country: Thailand
facility: The Golden Jubilee Medical Center ( Site 2800)
state: Nakhon Pathom
city: Hat-Yai
country: Thailand
facility: Songklanagarind Hospital ( Site 2802)
state: Songkhla
city: Halkali/K.cekmece
country: Turkey
facility: Atakent Acibadem Hastanesi ( Site 2103)
state: Istanbul
city: Ankara
country: Turkey
facility: Ankara Universitesi Ibni Sina Hastanesi ( Site 2101)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi ( Site 2102)
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2106)
city: Ankara
country: Turkey
facility: Ankara Sehir Hastanesi ( Site 2111)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 2110)
city: Istanbul
country: Turkey
facility: Medipol Universite Hastanesi ( Site 2108)
city: Istanbul
country: Turkey
facility: Basaksehir Cam ve Sakura City Hospital ( Site 2112)
city: Istanbul
country: Turkey
facility: Sancaktepe Prof Dr Ilhan Varank EAH-Prof Dr Feriha Oz Hastanesi ( Site 2113)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2105)
city: Sakarya
country: Turkey
facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2107)
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 2232)
state: Ivano-Frankivska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Regional Phthisiopulmonological Center ( Site 2203)
state: Ivano-Frankivska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: NPME -Central Clinical Hospital of Ivano-Frankivsk City Council ( Site 2204)
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 2229)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 2201)
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: Limited Liability Company Medical center Healthy Happy ( Site 2225)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: MNPE Consultative-Diagnostic Centre of Desnyanskyi District of Kyiv ( Site 2205)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv railway clinical hospital 2 of Branch Health center ( Site 2207)
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 2200)
state: Lvivska Oblast
city: Odesa
country: Ukraine
facility: Odesa Regional Center of Socially Significant Diseases ( Site 2230)
state: Odeska Oblast
city: Odessa
country: Ukraine
facility: MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 2226)
state: Odeska Oblast
city: Poltava
country: Ukraine
facility: Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 2227)
state: Poltavska Oblast
city: Vinnytsia
country: Ukraine
facility: Medical Clinical Investigational Center of Medical Center Health Clinic ( Site 2210)
state: Vinnytska Oblast
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.