Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)
NCT ID: NCT05605093
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
602 participants
INTERVENTIONAL
2022-12-23
2025-10-28
Brief Summary
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The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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S-217622 (ensitrelvir) plus standard of care (SOC)
Study investigational agent (ensitrelvir) will be administered as oral tablets with dosing of 375mg (3 tabs) once on Day 0 and 125mg (1 tab) once daily on Days 1-4. All participants will receive the full 5-day course, including those who are discharged from hospitalization prior to Day 4.
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 plus standard of care (SOC)
Study investigational placebo will be administered as oral tablets with dosing of 375mg (3 tabs) once on Day 0 and 125mg (1 tab) once daily on Days 1-4. All participants will receive the full 5-day course, including those who are discharged from hospitalization prior to Day 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent for trial participation.
* Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection.
* Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non- NAT test \[list of approved tests is in the PIM\] collected within the prior 14 days.
* Onset of symptoms attributable to SARS-CoV2 infection occurred within 14 days before randomization.
* Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection.
Exclusion Criteria
* Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization.
* Use of a strong CYP3A inducer within 14 days prior to enrollment
* Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization.
* Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life.
* Expected inability or unwillingness to participate in study procedures.
* In the opinion of the investigator, participation in a trial is not in the best interest of the patient.
* Allergy to investigational agent or vehicle
* Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622
* Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure.
* Known estimated glomerular filtration rate (eGRF) \<30 mL/min/1.73m 2
* Continuous renal replacement therapy or chronic dialysis
* Current pregnancy
* Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent.
* Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investigational agent.
* Men who are unwilling to abstain from sexual intercourse with women of child- bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent.
* Inability to take investigational agent in tablet form by mouth.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Cavan Reilly, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Jason Baker, MD
Role: STUDY_CHAIR
University of Minnesota
Locations
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University of Alabama Birmingham University Hospital (Site 213-002)
Birmingham, Alabama, United States
Banner University Medical Center Tucson (Site 206-004)
Tucson, Arizona, United States
Southern Arizona VA Healthcare System (Site 074-009)
Tucson, Arizona, United States
UCSF Fresno (Site 203-005)
Fresno, California, United States
VA Loma Linda Healthcare System (Site 074-017)
Loma Linda, California, United States
MemorialCare Health System (Site 066-003
Long Beach, California, United States
VA Long Beach Healthcare System (Site 074-026)
Long Beach, California, United States
Cedars-Sinai Medical Center (Site 208-002)
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center (Site 203-002)
Los Angeles, California, United States
VA Northern California Health Care System (Site 074-023)
Mather, California, United States
Hoag Memorial Hospital Presbyterian (Site 080-026)
Newport Beach, California, United States
Veterans Affairs Palo Alto Health Care System (VAPAHCS) (Site 074-005)
Palo Alto, California, United States
UC Davis Health (Site 203-004)
Sacramento, California, United States
VA San Diego Healthcare System (Site 074-016)
San Diego, California, United States
Zuckerberg San Francisco General Hospital and Trauma Center (Site 213-007)
San Francisco, California, United States
UCSF Medical Center at Mount Zion (203-007)
San Francisco, California, United States
San Francisco VAMC (Site 074-002)
San Francisco, California, United States
University of California San Francisco (Site 203-001)
San Francisco, California, United States
Stanford University Hospital & Clinics (Site 203-003)
Stanford, California, United States
Lundquist Institute for Biomedical Innovation (Site 066-002)
Torrance, California, United States
Rocky Mountain Regional VA Medical Center (Site 074-010)
Aurora, Colorado, United States
University of Colorado Hospital (Site 204-001)
Aurora, Colorado, United States
Public Health Institute at Denver Health (Site 017-004)
Denver, Colorado, United States
Yale University (Site 025-001)
New Haven, Connecticut, United States
MedStar Health Research Institute/MedStar Washington Hospital Center (Site 009-021)
Washington D.C., District of Columbia, United States
Washington DC VA Medical Center (Site 009-004)
Washington D.C., District of Columbia, United States
University of Florida - Gainesville (Site 201-004)
Gainesville, Florida, United States
Miami VA Healthcare System (Site 074-003)
Miami, Florida, United States
Orlando VA Medical Center (Site 074-032)
Orlando, Florida, United States
Tampa General Hospital (032-001)
Tampa, Florida, United States
John H. Stroger, Jr. Hospital of Cook County (Site 080-046)
Chicago, Illinois, United States
University of Illinois at Chicago (Site 008-012)
Chicago, Illinois, United States
Carle Foundation Hospital (Site 080-049)
Urbana, Illinois, United States
Lutheran Medical Group (Site 301-010)
Fort Wayne, Indiana, United States
The University of Kansas Hospital (Site 080-044)
Kansas City, Kansas, United States
University of Kentucky (Site 210-004)
Lexington, Kentucky, United States
NIH Clinical Center (Site 080-043)
Bethesda, Maryland, United States
Massachusetts General Hospital (202-002)
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (Site 202-001)
Boston, Massachusetts, United States
Baystate Medical Center (Site 201-001)
Springfield, Massachusetts, United States
UMass Chan Medical School (Site 080-007)
Worcester, Massachusetts, United States
VA Ann Arbor Healthcare System (Site 074-028)
Ann Arbor, Michigan, United States
Henry Ford Health System (Site 014-001)
Detroit, Michigan, United States
Sinai-Grace Hospital (Site 205-005)
Detroit, Michigan, United States
Hennepin Healthcare Research Institute (Site 027-001)
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center (Site 112-001)
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic (Site 054-001)
Rochester, Minnesota, United States
University of Mississippi Medical Center (Site 202-005)
Jackson, Mississippi, United States
Washington University School of Medicine (Site 003-001)
St Louis, Missouri, United States
University of Nebraska Medical Center (Site 080-045)
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center (301-024)
Lebanon, New Hampshire, United States
Cooper University Hospital (Site 019-001)
Camden, New Jersey, United States
Hackensack Meridian Health (Site 301-030)
Hackensack, New Jersey, United States
New Jersey Medical School Clinical Research Center (028-001)
Newark, New Jersey, United States
University of New Mexico Hospital (Site 213-008)
Albuquerque, New Mexico, United States
CHRISTUS - St. Vincent (Site 080-051)
Santa Fe, New Mexico, United States
NYU Brooklyn (301-033)
Brooklyn, New York, United States
New York Presbyterian Queens (003-005)
Flushing, New York, United States
Mount Sinai Queens (Site 081-105)
Long Island City, New York, United States
NYU Long Island (301-034)
Mineola, New York, United States
New York University Tisch Hospital (Site 301-013)
New York, New York, United States
Mount Sinai Medical Center (Site 301-012)
New York, New York, United States
NYC Health + Hospital Harlem (Site 003-003)
New York, New York, United States
Weill Cornell Clinical Research Unit (065-001)
New York, New York, United States
St. Lawrence Health System (Site 301-029)
Potsdam, New York, United States
Lincoln Medical Center (Site 003-016)
The Bronx, New York, United States
Montefiore Medical Center - Moses Hospital (Site 206-001)
The Bronx, New York, United States
Montefiore Medical Center - Weiler campus (Site 206-003)
The Bronx, New York, United States
James J. Peters VAMC (Site 023-003)
The Bronx, New York, United States
Duke University Hospital (Site 301-006)
Durham, North Carolina, United States
Wake Forest Baptist Health (Site 210-001)
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center (Site 207-003)
Cincinnati, Ohio, United States
Cleveland Clinic Foundation (Site 207-001)
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center (Site 207-004)
Columbus, Ohio, United States
Portland VA Health Care System (074-024)
Portland, Oregon, United States
Penn State Health Milton S. Hershey Medical Center (Site 209-002)
Hershey, Pennsylvania, United States
Rhode Island Hospital (Site 080-036)
Providence, Rhode Island, United States
The Miriam Hospital (Site 080-039)
Providence, Rhode Island, United States
Kent County Memorial Hospital (080-048)
Warwick, Rhode Island, United States
Ralph H. Johnson VA Medical Center (Site 074-015)
Charleston, South Carolina, United States
Medical University of South Carolina (Site 210-002)
Charleston, South Carolina, United States
Monument Health Rapid City Hospital (Site 213-005)
Rapid City, South Dakota, United States
Vanderbilt University Medical Center (Site 212-001)
Nashville, Tennessee, United States
Hendrick Medical Center (Site 080-014)
Abilene, Texas, United States
CHRISTUS Spohn Shoreline Hospital (Site 080-001)
Corpus Christi, Texas, United States
Baylor, Scott and White Health (301-003)
Dallas, Texas, United States
Parkland Health and Hospital Systems (Site 084-002)
Dallas, Texas, United States
UT Southwestern Medical Center (Site 084-001)
Dallas, Texas, United States
Houston Methodist Hospital (Site 301-028)
Houston, Texas, United States
MEDVAMC (Site 074-006)
Houston, Texas, United States
University of Texas Health Science Center (Site 203-006)
Houston, Texas, United States
CHRISTUS Good Shepherd Medical Center (Site 080-031)
Longview, Texas, United States
UT Health San Antonio (Site 009-022)
San Antonio, Texas, United States
Intermountain Medical Center (Site 211-001)
Murray, Utah, United States
University of Utah Health (Site 211-002)
Salt Lake City, Utah, United States
University of Virginia Health System, University Hospital (Site 210-003)
Charlottesville, Virginia, United States
Salem VA Medical Center (Site 074-014)
Salem, Virginia, United States
Harborview Medical Center (208-001)
Seattle, Washington, United States
Providence (Sacred Heart) (Site 213-004)
Spokane, Washington, United States
West Virginia University Medicine (301-023)
Morgantown, West Virginia, United States
William S. Middleton Memorial Veterans Hospital (074-030)
Madison, Wisconsin, United States
Froedtert Memorial Lutheran Hospital (052-001)
Milwaukee, Wisconsin, United States
Instituto Medico Platense (Site 611-025)
La Plata, Buenos Aires, Argentina
Sanatorio Allende (Site 611-030)
Córdoba, Córdoba Province, Argentina
Clínica Central S.A. (611-028)
Villa Regina, Río Negro Province, Argentina
Sanatorio Británico S.A. (611-027)
Rosario, Santa Fe Province, Argentina
CEMIC (Site 611-021)
Buenos Aires, , Argentina
Hospital Rawson (Site 611-012)
Córdoba, , Argentina
Sanatorio Medico de Diagnostico y Tratamiento (611-029)
Santa Fe, , Argentina
South Western Sydney Local Health District, Liverpool (Site 612-063)
Liverpool, New South Wales, Australia
St. Vincent's Hospital (Site 612-002)
Sydney, New South Wales, Australia
Westmead Hospital (Site 612-058)
Westmead, New South Wales, Australia
Austin Health (612-020)
Heidelberg, Victoria, Australia
The Alfred Hospital (Site 612-017)
Melbourne, Victoria, Australia
Fundação Universidade Caxias do Sul Hospital Geral (649-218)
Caxias do Sul, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre (649-101)
Porto Alegre, Rio Grande do Sul, Brazil
Sociedade Literária e Caritativa Santo Agostinho - Hospital São José (Site 649-204)
Criciúma, Santa Catarina, Brazil
Hospital Nereu Ramos (Site 649-210)
Florianópolis, Santa Catarina, Brazil
Unimed Joinville Cooperativa de Trabalho Médico (Site 649-202)
Joinville, Santa Catarina, Brazil
Associação Beneficente Hospital Universitário - Universidade de Marília (Site 649-212)
Marília, São Paulo, Brazil
Instituto de Infectologia Emílio Ribas - IIER (Site 649-001)
São Paulo, São Paulo, Brazil
Real e Benemérita Associação Portuguesa de Beneficência de São Paulo (Site 649-201
São Paulo, São Paulo, Brazil
Hospital Alemão Oswaldo Cruz (649-215)
São Paulo, São Paulo, Brazil
Associação Beneficente Síria - HCor (Site 649-203)
São Paulo, São Paulo, Brazil
Hospital SEPACO (649-207)
São Paulo, São Paulo, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio-Libanês (Site 649-217)
São Paulo, São Paulo, Brazil
Aarhus Universitetshospital, Skejby (625-002)
Aarhus, N, Denmark
Aalborg Hospital (Site 625-005)
Aalborg, , Denmark
Rigshospitalet, CHIP (Site 625-006)
Copenhagen, , Denmark
Bispebjerg Hospital (Site 625-013)
Copenhagen, , Denmark
Herlev/Gentofte Hospital (Site 625-012)
Hellerup, , Denmark
Nordsjaellands Hospital, Hillerod (Site 625-009)
Hillerød, , Denmark
Hvidovre University Hospital, Department of Infections Diseases (Site 625-001)
Hvidovre, , Denmark
Kolding Sygehus, Medicinsk Afdeling (Site 625-011)
Kolding, , Denmark
Odense University Hospital (Site 625-004)
Odense, , Denmark
Zealand University Hospital Roskilde (Site 625-010)
Roskilde, , Denmark
AIDS and Clinical Immunology Research Center (Site 627-201)
Tbilisi, , Georgia
Universitätsklinikum Bonn, Medizinische Klinik I, Immunologische Ambulanz (622-010)
Bonn, , Germany
Klinik I für Innere Medizin der Universität zu Köln (Site 622-008)
Cologne, , Germany
Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS (622-001)
Frankfurt, , Germany
Dept of Critical Care and Pulmonary Medicine, Evangelismos General Hospital (635-020)
Athens, Attica, Greece
1st Respiratory Medicine Dept, Athens University Medical School (635-015)
Athens, Attica, Greece
3rd Dept of Medicine, Medical School (635-022)
Athens, Attica, Greece
Attikon University General Hospital (Site 635-009)
Athens, Attica, Greece
Democritus University of Thrace (635-021)
Alexandroupoli, Evros, Greece
Fujita Health University Hospital (Site 612-105)
Toyoake, Aichi-ken, Japan
Center Hospital of the National Center for Global Health and Medicine (Site 612-101)
Shinjuku-Ku, Tokyo, Japan
Rinku General Medical Center (Site 612-107)
Osaka, , Japan
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Site 653-001)
Mexico City, Mexico City, Mexico
Instituto Nacional de Enfermedades Respiratorias Ismael Cosió Villegas (Site 653-002)
Mexico City, Mexico City, Mexico
Hospital General Dr. Aurelio Valdivieso (Site 653-004)
Oaxaca City, OA, Mexico
Institute of Human Virology-Nigeria (IHVN) (Site 612-601)
Abuja, Federal Capital Territory, Nigeria
Hospital Nacional Hipolito Unanue (651-008)
Lima, , Peru
Hospital Nacional Sergio E. Bernales (651-007)
Lima, , Peru
Wojewodzki Szpital Zakazny (Site 625-302)
Warsaw, , Poland
VA Caribbean Health Care (074-033)
San Juan, PR, Puerto Rico
Tan Tock Seng Hospital (Site 612-201)
Singapore, , Singapore
Durban International Clinical Research Site (WWH) (652-005)
Durban, KwaZulu-Natal, South Africa
Greys Hospital (080-202)
Pietermaritzburg, KwaZulu-Natal, South Africa
University of Cape Town (UCT) Lung Institute (Site 080-201)
Cape Town, Western Cape, South Africa
Seoul National University Bundang Hospital (Site 612-904)
Seongnam-si, Gyeonggi-do, South Korea
Seoul St. Mary's Hospital (Site 612-903)
Seocho, Seoul, South Korea
Asan Medical Center (612-901)
Seoul, , South Korea
Chung-Ang University Hospital (Site 612-902)
Seoul, , South Korea
Hospital Universitari Germans Trias i Pujol (626-003)
Badalona, Barcelona, Spain
Hospital del Mar (626-025)
Barcelona, , Spain
Hospital Universitari Vall d'Hebron (Site 626-033)
Barcelona, , Spain
Hospital Clinic de Barcelona (626-004)
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón (Site 626-001)
Madrid, , Spain
Hospital Clínico San Carlos (Site 626-017)
Madrid, , Spain
Hospital Universitario La Paz (Site 626-012)
Madrid, , Spain
University Hospital Zurich (Site 621-201)
Zurich, , Switzerland
Chulalongkorn University and The HIV-NAT (Site 613-001)
Bangkok, , Thailand
Khon Kaen University, Srinagarind Hospital (Site 613-003)
Khon Kaen, , Thailand
MRC/UVRI & LSHTM Uganda Research Unit (634-601)
Entebbe, , Uganda
Gulu Regional Referral Hospital (634-603)
Gulu, , Uganda
St. Francis Hospital, Nsambya (Site 634-607)
Kampala, , Uganda
Lira Regional Referral Hospital (634-605)
Lira, , Uganda
Masaka Regional Referral Hospital (634-606)
Masaka, , Uganda
Central City Clinical Hospital of Ivano-Frankivsk City Council (Site 627-302)
Ivano-Frankivsk, , Ukraine
Treatment and Diagnostic Center ADONIS Plus (627-304)
Kyiv, , Ukraine
Hospital #1 of Zhytomyr City Council (627-303)
Zhytomyr, , Ukraine
Royal Free Hospital (634-006)
London, , United Kingdom
Guy's & St. Thomas' NHS Foundation Trust (Site 634-011)
London, , United Kingdom
Royal Victoria Infirmary (Site 634-007)
Newcastle upon Tyne, , United Kingdom
Parirenyatwa General Hospital (Site 634-901)
Harare, , Zimbabwe
Countries
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Other Identifiers
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S-217622
Identifier Type: -
Identifier Source: org_study_id
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