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TERMINATED
NCT05605093
PHASE3

Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)

Sponsor: University of Minnesota

View on ClinicalTrials.gov

Summary

Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi \&; Co. Ltd. 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.

Official title: Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

602

Start Date

2022-12-23

Completion Date

2025-10-28

Last Updated

2026-09-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

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).

DRUG

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.

Locations (187)

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