602
Participants
Start Date
December 23, 2022
Primary Completion Date
November 30, 2025
Study Completion Date
November 30, 2025
Shionogi Protease Inhibitor (S-217622)
S-217622 (ensitrelvir) is an oral anti-SARS-CoV2 PI that does not require ritonavir co-administration The dose is 375/125 (375 mg on Day 0, followed by 125 mg daily on Days 1-4).
placebo
Placebo is an oral tablet administered once (3 tabs) on Day 0 and once (1 tab) daily on days 1-4, 5-day course.
Aarhus Universitetshospital, Skejby (625-002), Aarhus
Hospital #1 of Zhytomyr City Council (627-303), Zhytomyr
CEMIC (Site 611-021), Buenos Aires
Sanatorio Británico S.A. (611-027), Rosario
St. Vincent's Hospital (Site 612-002), Sydney
Rigshospitalet, CHIP (Site 625-006), Copenhagen
Westmead Hospital (Site 612-058), Westmead
South Western Sydney Local Health District, Liverpool (Site 612-063), Liverpool
Bispebjerg Hospital (Site 625-013), Copenhagen
Hvidovre University Hospital, Department of Infections Diseases (Site 625-001), Hvidovre
Herlev/Gentofte Hospital (Site 625-012), Hellerup
Sanatorio Medico de Diagnostico y Tratamiento (611-029), Santa Fe
The Alfred Hospital (Site 612-017), Melbourne
Austin Health (612-020), Heidelberg
Greys Hospital (080-202), Pietermaritzburg
Nordsjaellands Hospital, Hillerod (Site 625-009), Hillerød
Zealand University Hospital Roskilde (Site 625-010), Roskilde
Durban International Clinical Research Site (WWH) (652-005), Durban
Hospital Rawson (Site 611-012), Córdoba
Odense University Hospital (Site 625-004), Odense
Kolding Sygehus, Medicinsk Afdeling (Site 625-011), Kolding
University of Cape Town (UCT) Lung Institute (Site 080-201), Cape Town
University Hospital Zurich (Site 621-201), Zurich
Aalborg Hospital (Site 625-005), Aalborg
New York University Tisch Hospital (Site 301-013), New York
Mount Sinai Medical Center (Site 301-012), New York
NYC Health + Hospital Harlem (Site 003-003), New York
Weill Cornell Clinical Research Unit (065-001), New York
Chulalongkorn University and The HIV-NAT (Site 613-001), Bangkok
Lincoln Medical Center (Site 003-016), The Bronx
Montefiore Medical Center - Moses Hospital (Site 206-001), The Bronx
Montefiore Medical Center - Weiler campus (Site 206-003), The Bronx
James J. Peters VAMC (Site 023-003), The Bronx
Dept of Critical Care and Pulmonary Medicine, Evangelismos General Hospital (635-020), Athens
Mount Sinai Queens (Site 081-105), Long Island City
NYU Brooklyn (301-033), Brooklyn
New York Presbyterian Queens (003-005), Flushing
NYU Long Island (301-034), Mineola
1st Respiratory Medicine Dept, Athens University Medical School (635-015), Athens
3rd Dept of Medicine, Medical School (635-022), Athens
Attikon University General Hospital (Site 635-009), Athens
Seoul National University Bundang Hospital (Site 612-904), Seongnam-si
St. Lawrence Health System (Site 301-029), Potsdam
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Site 653-001), Mexico City
Instituto Nacional de Enfermedades Respiratorias Ismael Cosió Villegas (Site 653-002), Mexico City
Hospital Nacional Hipolito Unanue (651-008), Lima
Hospital Nacional Sergio E. Bernales (651-007), Lima
Penn State Health Milton S. Hershey Medical Center (Site 209-002), Hershey
MedStar Health Research Institute/MedStar Washington Hospital Center (Site 009-021), Washington D.C.
Washington DC VA Medical Center (Site 009-004), Washington D.C.
NIH Clinical Center (Site 080-043), Bethesda
University of Virginia Health System, University Hospital (Site 210-003), Charlottesville
Salem VA Medical Center (Site 074-014), Salem
West Virginia University Medicine (301-023), Morgantown
Wake Forest Baptist Health (Site 210-001), Winston-Salem
Duke University Hospital (Site 301-006), Durham
Hospital General Universitario Gregorio Marañón (Site 626-001), Madrid
Hospital Clínico San Carlos (Site 626-017), Madrid
Hospital Universitario La Paz (Site 626-012), Madrid
Ralph H. Johnson VA Medical Center (Site 074-015), Charleston
Medical University of South Carolina (Site 210-002), Charleston
University of Florida - Gainesville (Site 201-004), Gainesville
Orlando VA Medical Center (Site 074-032), Orlando
Miami VA Healthcare System (Site 074-003), Miami
Tampa General Hospital (032-001), Tampa
University of Alabama Birmingham University Hospital (Site 213-002), Birmingham
Vanderbilt University Medical Center (Site 212-001), Nashville
University of Mississippi Medical Center (Site 202-005), Jackson
Khon Kaen University, Srinagarind Hospital (Site 613-003), Khon Kaen
University of Kentucky (Site 210-004), Lexington
Ohio State University Wexner Medical Center (Site 207-004), Columbus
Cleveland Clinic Foundation (Site 207-001), Cleveland
University of Cincinnati Medical Center (Site 207-003), Cincinnati
Lutheran Medical Group (Site 301-010), Fort Wayne
VA Ann Arbor Healthcare System (Site 074-028), Ann Arbor
Henry Ford Health System (Site 014-001), Detroit
Sinai-Grace Hospital (Site 205-005), Detroit
Klinik I für Innere Medizin der Universität zu Köln (Site 622-008), Cologne
Universitätsklinikum Bonn, Medizinische Klinik I, Immunologische Ambulanz (622-010), Bonn
Froedtert Memorial Lutheran Hospital (052-001), Milwaukee
William S. Middleton Memorial Veterans Hospital (074-030), Madison
Hennepin Healthcare Research Institute (Site 027-001), Minneapolis
M Health Fairview University of Minnesota Medical Center (Site 112-001), Minneapolis
University of Minnesota, Minneapolis
Mayo Clinic (Site 054-001), Rochester
Monument Health Rapid City Hospital (Site 213-005), Rapid City
Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS (622-001), Frankfurt
John H. Stroger, Jr. Hospital of Cook County (Site 080-046), Chicago
University of Illinois at Chicago (Site 008-012), Chicago
Carle Foundation Hospital (Site 080-049), Urbana
Washington University School of Medicine (Site 003-001), St Louis
The University of Kansas Hospital (Site 080-044), Kansas City
Hospital General Dr. Aurelio Valdivieso (Site 653-004), Oaxaca City
Democritus University of Thrace (635-021), Alexandroupoli
University of Nebraska Medical Center (Site 080-045), Omaha
Baylor, Scott and White Health (301-003), Dallas
Parkland Health and Hospital Systems (Site 084-002), Dallas
UT Southwestern Medical Center (Site 084-001), Dallas
CHRISTUS Good Shepherd Medical Center (Site 080-031), Longview
Central City Clinical Hospital of Ivano-Frankivsk City Council (Site 627-302), Ivano-Frankivsk
Houston Methodist Hospital (Site 301-028), Houston
MEDVAMC (Site 074-006), Houston
University of Texas Health Science Center (Site 203-006), Houston
UT Health San Antonio (Site 009-022), San Antonio
CHRISTUS Spohn Shoreline Hospital (Site 080-001), Corpus Christi
Hendrick Medical Center (Site 080-014), Abilene
Rocky Mountain Regional VA Medical Center (Site 074-010), Aurora
University of Colorado Hospital (Site 204-001), Aurora
Public Health Institute at Denver Health (Site 017-004), Denver
Intermountain Medical Center (Site 211-001), Murray
University of Utah Health (Site 211-002), Salt Lake City
Banner University Medical Center Tucson (Site 206-004), Tucson
Southern Arizona VA Healthcare System (Site 074-009), Tucson
University of New Mexico Hospital (Site 213-008), Albuquerque
CHRISTUS - St. Vincent (Site 080-051), Santa Fe
Cedars-Sinai Medical Center (Site 208-002), Los Angeles
Ronald Reagan UCLA Medical Center (Site 203-002), Los Angeles
Hospital de Clínicas de Porto Alegre (649-101), Porto Alegre
Lundquist Institute for Biomedical Innovation (Site 066-002), Torrance
MemorialCare Health System (Site 066-003, Long Beach
VA Long Beach Healthcare System (Site 074-026), Long Beach
VA San Diego Healthcare System (Site 074-016), San Diego
VA Loma Linda Healthcare System (Site 074-017), Loma Linda
Hoag Memorial Hospital Presbyterian (Site 080-026), Newport Beach
UCSF Fresno (Site 203-005), Fresno
Zuckerberg San Francisco General Hospital and Trauma Center (Site 213-007), San Francisco
UCSF Medical Center at Mount Zion (203-007), San Francisco
San Francisco VAMC (Site 074-002), San Francisco
University of California San Francisco (Site 203-001), San Francisco
Veterans Affairs Palo Alto Health Care System (VAPAHCS) (Site 074-005), Palo Alto
Stanford University Hospital & Clinics (Site 203-003), Stanford
VA Northern California Health Care System (Site 074-023), Mather
UC Davis Health (Site 203-004), Sacramento
Portland VA Health Care System (074-024), Portland
Harborview Medical Center (208-001), Seattle
Providence (Sacred Heart) (Site 213-004), Spokane
Tan Tock Seng Hospital (Site 612-201), Singapore
Yale University (Site 025-001), New Haven
Massachusetts General Hospital (202-002), Boston
Beth Israel Deaconess Medical Center (Site 202-001), Boston
Baystate Medical Center (Site 201-001), Springfield
UMass Chan Medical School (Site 080-007), Worcester
Dartmouth-Hitchcock Medical Center (301-024), Lebanon
Cooper University Hospital (Site 019-001), Camden
Hackensack Meridian Health (Site 301-030), Hackensack
New Jersey Medical School Clinical Research Center (028-001), Newark
Rhode Island Hospital (Site 080-036), Providence
The Miriam Hospital (Site 080-039), Providence
Kent County Memorial Hospital (080-048), Warwick
Instituto Medico Platense (Site 611-025), La Plata
Sanatorio Allende (Site 611-030), Córdoba
Clínica Central S.A. (611-028), Villa Regina
Fundação Universidade Caxias do Sul Hospital Geral (649-218), Caxias do Sul
Sociedade Literária e Caritativa Santo Agostinho - Hospital São José (Site 649-204), Criciúma
Hospital Nereu Ramos (Site 649-210), Florianópolis
Unimed Joinville Cooperativa de Trabalho Médico (Site 649-202), Joinville
Associação Beneficente Hospital Universitário - Universidade de Marília (Site 649-212), Marília
Instituto de Infectologia Emílio Ribas - IIER (Site 649-001), São Paulo
Real e Benemérita Associação Portuguesa de Beneficência de São Paulo (Site 649-201, São Paulo
Hospital Alemão Oswaldo Cruz (649-215), São Paulo
Associação Beneficente Síria - HCor (Site 649-203), São Paulo
Hospital SEPACO (649-207), São Paulo
Sociedade Beneficente de Senhoras Hospital Sirio-Libanês (Site 649-217), São Paulo
AIDS and Clinical Immunology Research Center (Site 627-201), Tbilisi
Fujita Health University Hospital (Site 612-105), Toyoake
Center Hospital of the National Center for Global Health and Medicine (Site 612-101), Shinjuku-Ku
Rinku General Medical Center (Site 612-107), Osaka
Institute of Human Virology-Nigeria (IHVN) (Site 612-601), Abuja
MRC/UVRI & LSHTM Uganda Research Unit (634-601), Entebbe
Gulu Regional Referral Hospital (634-603), Gulu
St. Francis Hospital, Nsambya (Site 634-607), Kampala
Lira Regional Referral Hospital (634-605), Lira
Masaka Regional Referral Hospital (634-606), Masaka
Parirenyatwa General Hospital (Site 634-901), Harare
Wojewodzki Szpital Zakazny (Site 625-302), Warsaw
VA Caribbean Health Care (074-033), San Juan
Seoul St. Mary's Hospital (Site 612-903), Seocho
Asan Medical Center (612-901), Seoul
Chung-Ang University Hospital (Site 612-902), Seoul
Hospital Universitari Germans Trias i Pujol (626-003), Badalona
Hospital del Mar (626-025), Barcelona
Hospital Universitari Vall d'Hebron (Site 626-033), Barcelona
Hospital Clinic de Barcelona (626-004), Barcelona
Treatment and Diagnostic Center ADONIS Plus (627-304), Kyiv
Royal Free Hospital (634-006), London
Guy's & St. Thomas' NHS Foundation Trust (Site 634-011), London
Royal Victoria Infirmary (Site 634-007), Newcastle upon Tyne
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of Minnesota
OTHER