Clinical trial NCT04575597: Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)
Official title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronavirus Disease (COVID-19)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 1735
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29


Eligibility criteria: Inclusion Criteria:

* Has documentation of laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with sample collection ≤5 days prior to the day of randomization. PCR is the preferred method; however with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (RNA) or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed.
* Had initial onset of signs/symptoms attributable to COVID-19 for ≤5 days prior to the day of randomization and at least 1 of the following sign/symptom attributable to COVID-19 on the day of randomization.
* Has mild or moderate COVID-19.
* Has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19.
* Males agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: Either abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception.
* Females are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for at least 4 days after the last dose of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

Exclusion Criteria:

* Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization.
* Is on dialysis or has reduced estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2 by the Modification of Diet in Renal Disease (MDRD) equation.
* Has any of the following conditions: human immunodeficiency virus (HIV) with a recent viral load \>50 copies/mL (regardless of CD4 count) or an AIDS-defining illness in the past 6 months, participants with HIV may only be enrolled if on a stable antiretroviral therapy regimen; a neutrophilic granulocyte absolute count \<500/mm\^3.
* Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3X upper limit of normal at screening.
* Has a platelet count \<100,000/μL or received a platelet transfusion in the 5 days prior to randomization.
* Is taking or is anticipated to require any prohibited therapies.
* 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.
* 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 who are not expected to survive longer than 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents.

Primary outcomes:
measure: Percentage of Participants Who Were Hospitalized and/or Died Through Day 29 (Primary Pre-specified Analysis)
timeFrame: Up to 29 days
measure: Number of Participants With an Adverse Event (AE)
timeFrame: Up to 318 days
measure: Number of Participants Who Discontinued Study Intervention Due to an AE
timeFrame: Up to 5 days
Secondary outcomes:
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Cough
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Sore Throat
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Muscles or Body Aches
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Fatigue
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Chills
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Headache
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Nausea
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Vomiting
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Diarrhea
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Taste
timeFrame: Up to 29 days
measure: Time to Sustained Resolution or Improvement of Each Targeted COVID-19 Sign/Symptom - Loss of Smell
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Cough
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Sore Throat
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nasal Congestion
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Rhinorrhea
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Shortness of Breath or Difficulty Breathing
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Muscle or Body Aches
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Fatigue
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Feeling Hot or Feverish
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Chills
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Headache
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Nausea
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Vomiting
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Diarrhea
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Taste
timeFrame: Up to 29 days
measure: Time to Progression of Each Targeted COVID-19 Sign/Symptom - Loss of Smell
timeFrame: Up to 29 days
measure: Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 3
timeFrame: Day 3
measure: Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on End of Treatment (EOT [Day 5])
timeFrame: EOT (Day 5)
measure: Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 10
timeFrame: Day 10
measure: Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 15
timeFrame: Day 15
measure: Number of Participants With Responses on WHO 11-point Ordinal Outcomes Score on a Scale on Day 29
timeFrame: Day 29
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Phoenix Medical Group ( Site 1822)
state: Arizona
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group, Inc. ( Site 2406)
state: California
city: Los Angeles
country: United States
facility: Men's Health Foundation ( Site 1820)
state: California
city: North Hollywood
country: United States
facility: Carbon Health Technologies Inc ( Site 2505)
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center ( Site 1833)
state: California
city: Washington
country: United States
facility: Emerson Clinical Research Institute ( Site 1828)
state: District of Columbia
city: Atlantis
country: United States
facility: JEM Research Institute ( Site 2508)
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center ( Site 1837)
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc ( Site 1809)
state: Florida
city: Immokalee
country: United States
facility: Advanced Research For Health Improvement LLC ( Site 1816)
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research, LLC ( Site 1864)
state: Florida
city: Naples
country: United States
facility: Advanced Research For Health Improvement LLC ( Site 1813)
state: Florida
city: Orlando
country: United States
facility: Bliss Healthcare Services ( Site 1847)
state: Florida
city: Albany
country: United States
facility: Javara Inc. ( Site 1869)
state: Georgia
city: Columbus
country: United States
facility: IACT Health ( Site 1818)
state: Georgia
city: Fayetteville
country: United States
facility: Javara Inc. ( Site 1868)
state: Georgia
city: Chicago
country: United States
facility: Loretto Hospital ( Site 1886)
state: Illinois
city: Laurel
country: United States
facility: Jadestone Clinical Research, LLC ( Site 2502)
state: Maryland
city: Farmington Hills
country: United States
facility: Michigan Center of Medical Research ( Site 2500)
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center ( Site 2414)
state: Nebraska
city: Raritan
country: United States
facility: Amici Clinical Research LLC ( Site 2507)
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico, Health Sciences Center ( Site 1819)
state: New Mexico
city: Santa Fe
country: United States
facility: AXCES Research Group ( Site 2418)
state: New Mexico
city: Bellaire
country: United States
facility: Saint Hope Foundation, Inc. ( Site 1830)
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center, Inc. ( Site 1812)
state: Texas
city: Sugar Land
country: United States
facility: Javara Inc. ( Site 1866)
state: Texas
city: Richmond
country: United States
facility: Clinical Research Partners, LLC. ( Site 2503)
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center First Hill ( Site 1807)
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center ( Site 1829)
state: Washington
city: Spokane
country: United States
facility: Multicare Health System ( Site 1811)
state: Washington
city: University Place
country: United States
facility: Multicare Health System ( Site 1814)
state: Washington
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin ( Site 2510)
state: Wisconsin
city: Vicente Lopez
country: Argentina
facility: Clinica Independencia ( Site 3400)
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)
state: Santa Fe
city: Brasilia
country: Brazil
facility: Chronos Pesquisa Clínica ( Site 0155)
state: Distrito Federal
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0150)
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Hospital de Clinicas da Universidade Federal do Parana ( Site 0154)
state: Parana
city: Bento Goncalves
country: Brazil
facility: Hospital Tacchini ( Site 0157)
state: Rio Grande Do Sul
city: Sao Jose do Rio Preto
country: Brazil
facility: FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto de Infectologia Emilio Ribas ( Site 0153)
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152)
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group ( Site 0207)
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital ( Site 0201)
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0204)
state: Quebec
city: Rancagua
country: Chile
facility: Servicios Medicos Urumed ( Site 0307)
state: Lbtdr Gen Bernardo O Higgins
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA ( Site 0308)
state: Los Rios
city: Santiago
country: Chile
facility: Clinica Universidad de los Andes ( Site 0302)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez ( Site 0305)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Espacio EME ( Site 0304)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Investigacion Clinica UC CICUC ( Site 0309)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clinica Bicentenario Spa ( Site 0306)
state: Region M. De Santiago
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe ( Site 0405)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)
state: Atlantico
city: Barranquilla
country: Colombia
facility: Clinica de la Costa Ltda. ( Site 0403)
state: Atlantico
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 0407)
state: Cordoba
city: Bogota
country: Colombia
facility: Caja de Compensación Familiar CAFAM. Sede Centro de Atención en Salud CAFAM Floresta ( Site 0406)
state: Cundinamarca
city: Bogota
country: Colombia
facility: Centro de Atencion e Investigacion Medica CAIMED ( Site 0413)
state: Cundinamarca
city: Bogota
country: Colombia
facility: Fundacion Santa Fe de Bogota ( Site 0412)
state: Distrito Capital De Bogota
city: Bucaramanca
country: Colombia
facility: Fundacion Cardiovascular de Colombia ( Site 0402)
state: Santander
city: Cali
country: Colombia
facility: Fundacion Valle del Lili ( Site 0401)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A ( Site 0415)
state: Valle Del Cauca
city: Giza
country: Egypt
facility: National Center for allergies and chest ( Site 3320)
state: Al Jizah
city: Cairo
country: Egypt
facility: National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300)
state: Al Qahirah
city: Cairo
country: Egypt
facility: Abbassia Chest Hospital ( Site 3340)
state: Al Qahirah
city: Cairo
country: Egypt
facility: Abbassia Fever Hospital ( Site 3330)
state: Al Qahirah
city: Cairo
country: Egypt
facility: Helwan Fever Hospital ( Site 3350)
state: Al Qahirah
city: Paris
country: France
facility: Hopital Bichat Claude Bernard ( Site 0503)
state: Ain
city: Marseille
country: France
facility: Hopital Saint Joseph ( Site 0513)
state: Bouches-du-Rhone
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin ( Site 0511)
state: Gironde
city: Saint Pierre Cedex
country: France
facility: CHU de la Reunion - Groupe Hospitalier Sud ( Site 0514)
state: La Reunion
city: Toulouse
country: France
facility: C.H.U. de Toulouse Hopital Purpan ( Site 0501)
state: Midi-Pyrenees
city: Tourcoing
country: France
facility: Centre Hospitalier de Tourcoing ( Site 0502)
state: Nord
city: Paris
country: France
facility: CHU Hopital Saint Antoine ( Site 0505)
city: Paris
country: France
facility: Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)
city: Frankfurt a main
country: Germany
facility: Universitaetsklinikum Frankfurt ( Site 2302)
state: Hessen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 2305)
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301)
city: Hamburg
country: Germany
facility: ICH Study Center GmbH & Co.KG ( Site 2306)
city: Guatemala
country: Guatemala
facility: Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 2601)
city: Guatemala
country: Guatemala
facility: Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2600)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center. Ein Kerem ( Site 2100)
city: Napoles
country: Italy
facility: Asl Napoli 1 Centro ( Site 0610)
state: Napoli
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi ( Site 0604)
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino ( Site 0603)
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606)
city: Milano
country: Italy
facility: Ospedale San Raffaele ( Site 0605)
city: Milano
country: Italy
facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)
city: Milano
country: Italy
facility: Ospedale Niguarda ( Site 0608)
city: Palermo
country: Italy
facility: AOU Policlinico Paolo Giaccone ( Site 0609)
city: Roma
country: Italy
facility: Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 0600)
city: Torino
country: Italy
facility: Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602)
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale -ASU FC ( Site 0607)
city: Chiba
country: Japan
facility: Chiba Aoba Municipal Hospital ( Site 0702)
city: Tokyo
country: Japan
facility: Den-en-chofu family clinic ( Site 0701)
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine ( Site 0700)
city: Ciudad de mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)
state: Distrito Federal
city: Mexico City
country: Mexico
facility: CAIMED México ( Site 0814)
state: Distrito Federal
city: Leon
country: Mexico
facility: Hospital Regional de Alta Especialidad del Bajio ( Site 0807)
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)
state: Nuevo Leon
city: Cancun
country: Mexico
facility: Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0810)
state: Quintana Roo
city: Merida
country: Mexico
facility: Köhler & Milstein Research S.A. de C.V. ( Site 0809)
state: Yucatan
city: Chihuahua
country: Mexico
facility: ICARO Investigaciones en Medicina ( Site 0812)
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C. ( Site 0811)
city: Tlalnepantla de Baz
country: Mexico
facility: Clinical Research Institute S.C. ( Site 0813)
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V ( Site 0808)
city: Quezon City
country: Philippines
facility: Lung Center of the Philippines ( Site 0902)
state: National Capital Region
city: Quezon City
country: Philippines
facility: Quirino Memorial Medical Center ( Site 0903)
state: National Capital Region
city: Lodz
country: Poland
facility: NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)
state: Lodzkie
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o ( Site 1008)
state: Malopolskie
city: Piaseczno
country: Poland
facility: Centrum Medyczne Pulawska Sp. z o.o. ( Site 1007)
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Centrum Medyczne MEDYK Sp. z o.o. Sp.k. ( Site 1009)
state: Podkarpackie
city: Moscow
country: Russian Federation
facility: Central Scientific Research Institute of Epidemiology ( Site 1104)
state: Moskva
city: Moscow
country: Russian Federation
facility: Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1122)
state: Moskva
city: Moscow
country: Russian Federation
facility: Hadassah Medical LTD ( Site 1124)
state: Moskva
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital with Polyclinic ( Site 1105)
state: Moskva
city: Nizhny Novgorod
country: Russian Federation
facility: City Hospital No.33 of Leninsky ( Site 1127)
state: Nizhegorodskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: SPb SBHI City outpatient clinic 112 ( Site 1128)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Medical Research Institute LLC ( Site 1116)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Smorodintsev Research Institute of Influenza ( Site 1129)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: SPb SBHI City outpatient clinic 4 ( Site 1131)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Strategic Medical System LLC ( Site 1114)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: St.Petersburg Outpatient Clinic No. 109 ( Site 1119)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Limited liability company "Scientific research center Eco-safety" ( Site 1117)
state: Sankt-Peterburg
city: St.Petersburg
country: Russian Federation
facility: City Polyclinic N44 ( Site 1130)
state: Sankt-Peterburg
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University ( Site 1110)
state: Smolenskaya Oblast
city: Kazan
country: Russian Federation
facility: Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)
state: Tatarstan, Respublika
city: Bloemfontein
country: South Africa
facility: IATROS International ( Site 1212)
state: Free State
city: Johannesburg
country: South Africa
facility: Right To Care Research - Esizayo ( Site 1229)
state: Gauteng
city: Mpumalanga
country: South Africa
facility: Mzansi Ethical Research Centre ( Site 1225)
state: Gauteng
city: Pretoria-West
country: South Africa
facility: Jongaie Research ( Site 1223)
state: Gauteng
city: Soweto
country: South Africa
facility: Wits Baragwanath Clinical Trial Site ( Site 1214)
state: Gauteng
city: Durban
country: South Africa
facility: Enhancing Care Foundation-DICRS ( Site 1216)
state: Kwazulu-Natal
city: Thabazimbi
country: South Africa
facility: Limpopo Clinical Research Initiative ( Site 1227)
state: Limpopo
city: Cape Town
country: South Africa
facility: TREAD Research ( Site 1211)
state: Western Cape
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219)
state: Western Cape
city: Paarl
country: South Africa
facility: Be Part Yoluntu Centre ( Site 1218)
state: Western Cape
city: Paarl
country: South Africa
facility: Paarl Research Centre ( Site 1228)
state: Western Cape
city: Worcester
country: South Africa
facility: Clinical Projects Research Centre ( Site 1215)
state: Western Cape
city: Centelles
country: Spain
facility: CAP Centelles ( Site 1308)
state: Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 1302)
state: Madrid, Comunidad De
city: Alcorcon
country: Spain
facility: Fundacion Hospital Alcorcon de Madrid ( Site 1314)
state: Madrid
city: Barcelona
country: Spain
facility: CAP Sardenya - Barcelona ( Site 1307)
city: Barcelona
country: Spain
facility: Hospital Clinic ( Site 1304)
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol ( Site 1303)
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor ( Site 1310)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 1301)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 1300)
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 1400)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: ClinSmart Sweden AB.Uppsala ( Site 1402)
state: Uppsala Lan
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)
state: Vastra Gotalands Lan
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 3100)
city: Taoyuan
country: Taiwan
facility: Taoyuan General Hospital ( Site 3101)
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)
state: Ivano-Frankivska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)
state: Ivano-Frankivska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 1621)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 1627)
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: Limited Liability Company Medical center Healthy Happy ( Site 1625)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: LLC "Adonis plus" ( Site 1619)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv railway clinical hospital 2 of Branch Health center ( Site 1602)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: ARTEM. State Holding Company ( Site 1618)
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 1622)
state: Lvivska Oblast
city: Odessa
country: Ukraine
facility: MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 1626)
state: Odeska Oblast
city: Poltava
country: Ukraine
facility: Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614)
state: Poltavska Oblast
city: Vinnytsia
country: Ukraine
facility: Medical Center Health Clinic ( Site 1623)
state: Vinnytska Oblast
city: Poole
country: United Kingdom
facility: The Adam Practice ( Site 1708)
state: Dorset
city: Orpington
country: United Kingdom
facility: Accellacare South London Quality Research Centre ( Site 1709)
state: Kent
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust ( Site 1700)
state: London, City Of
city: London
country: United Kingdom
facility: King's College Hospital ( Site 1707)
state: London, City Of
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre ( Site 1705)
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Caraco Y, Crofoot GE, Moncada PA, Galustyan AN, Musungaie DB, Payne B, Kovalchuk E, Gonzalez A, Brown ML, Williams-Diaz A, Gao W, Strizki JM, Grobler J, Du J, Assaid CA, Paschke A, Butterton JR, Johnson MG, De Anda C. Phase 2/3 Trial of Molnupiravir for Treatment of Covid-19 in Nonhospitalized Adults. NEJM Evid. 2022 Feb;1(2):EVIDoa2100043. doi: 10.1056/EVIDoa2100043. Epub 2021 Dec 16.
citation: Johnson MG, Puenpatom A, Moncada PA, Burgess L, Duke ER, Ohmagari N, Wolf T, Bassetti M, Bhagani S, Ghosn J, Zhang Y, Wan H, Williams-Diaz A, Brown ML, Paschke A, De Anda C. Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 : A Randomized, Placebo-Controlled Trial. Ann Intern Med. 2022 Aug;175(8):1126-1134. doi: 10.7326/M22-0729. Epub 2022 Jun 7.
citation: Jayk Bernal A, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, Martin-Quiros A, Caraco Y, Williams-Diaz A, Brown ML, Du J, Pedley A, Assaid C, Strizki J, Grobler JA, Shamsuddin HH, Tipping R, Wan H, Paschke A, Butterton JR, Johnson MG, De Anda C; MOVe-OUT Study Group. Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med. 2022 Feb 10;386(6):509-520. doi: 10.1056/NEJMoa2116044. Epub 2021 Dec 16.