COVID-19 Clinical Trial
Official title:
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor
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.
| Status | Recruiting |
| Enrollment | 1500 |
| Est. completion date | July 27, 2025 |
| Est. primary completion date | July 27, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age =18 years. - 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: - The patient is expected to be discharged from the hospital within the next 24 hours. - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Sanatorio Medico de Diagnostico y Tratamiento (611-029) | Santa Fe | |
| Australia | Austin Health (612-020) | Heidelberg | Victoria |
| Australia | The Alfred Hospital (Site 612-017) | Melbourne | Victoria |
| Australia | St. Vincent's Hospital (Site 612-002) | Sydney | New South Wales |
| Australia | Westmead Hospital (Site 612-058) | Westmead | New South Wales |
| Denmark | Aalborg Hospital (Site 625-005) | Aalborg | |
| Denmark | Aarhus Universitetshospital, Skejby (625-002) | Aarhus | N |
| Denmark | Bispebjerg Hospital (Site 625-013) | Copenhagen | |
| Denmark | Rigshospitalet, CHIP (Site 625-006) | 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 | |
| Georgia | AIDS and Clinical Immunology Research Center (Site 627-201) | Tbilisi | |
| Germany | 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 | |
| Greece | Democritus University of Thrace (635-021) | Alexandroupolis | Evros |
| 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 | Dept of Critical Care and Pulmonary Medicine, Evangelismos General Hospital (635-020) | Athens | Attica |
| Japan | Center Hospital of the National Center for Global Health and Medicine (Site 612-101) | Shinjuku-Ku | Tokyo |
| Japan | Fujita Health University Hospital (Site 612-105) | Toyoake | Aichi |
| Korea, Republic of | Seoul St. Mary's Hospital (Site 612-903) | Seocho | Seoul |
| Korea, Republic of | Seoul National University Bundang Hospital (Site 612-904) | Seongnam | Gyeonggi |
| Korea, Republic of | Asan Medical Center (612-901) | Seoul | |
| Korea, Republic of | Chung-Ang University Hospital (Site 612-902) | Seoul | |
| Nigeria | Institute of Human Virology-Nigeria (IHVN) (Site 612-601) | Abuja | FCT |
| Puerto Rico | VA Caribbean Health Care (074-033) | San Juan | |
| Singapore | Tan Tock Seng Hospital (Site 612-201) | Singapore | |
| South Africa | University of Cape Town (UCT) Lung Institute (Site 080-201) | Cape Town | Western Cape |
| South Africa | Durban International Clinical Research Site (WWH) (652-005) | Durban | KwaZulu-Natal |
| South Africa | Greys Hospital (080-202) | Pietermaritzburg | KwaZulu-Natal |
| Spain | Hospital Universitari Germans Trias i Pujol (626-003) | Badalona | Barcelona |
| Spain | Hospital Clinic de Barcelona (626-004) | Barcelona | |
| Spain | Hospital del Mar (626-025) | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron (Site 626-033) | Barcelona | |
| Spain | Hospital Clínico San Carlos (Site 626-017) | Madrid | |
| Spain | Hospital General Universitario Gregorio Marañón (Site 626-001) | Madrid | |
| Spain | Hospital Universitario La Paz (Site 626-012) | Madrid | |
| Thailand | Chulalongkorn University and The HIV-NAT (Site 613-001) | Bangkok | |
| Thailand | Khon Kaen University, Srinagarind Hospital (Site 613-003) | Khon Kaen | |
| Uganda | 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 | |
| Ukraine | Central City Clinical Hospital of Ivano-Frankivsk City Council (Site 627-302) | Ivano-Frankivs'k | Frankivs'k |
| United Kingdom | Royal Victoria Infirmary (Site 634-007) | Newcastle Upon Tyne | |
| United States | Hendrick Medical Center (Site 080-014) | Abilene | Texas |
| United States | University of New Mexico Hospital (Site 213-008) | Albuquerque | New Mexico |
| United States | VA Ann Arbor Healthcare System (Site 074-028) | Ann Arbor | Michigan |
| 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 | NIH Clinical Center (Site 080-043) | Bethesda | Maryland |
| United States | University of Alabama Birmingham University Hospital (Site 213-002) | Birmingham | Alabama |
| United States | Beth Israel Deaconess Medical Center (Site 202-001) | Boston | Massachusetts |
| United States | Massachusetts General Hospital (202-002) | Boston | Massachusetts |
| United States | James J. Peters VAMC (Site 023-003) | Bronx | New York |
| United States | Lincoln Medical Center (Site 003-016) | Bronx | New York |
| United States | Montefiore Medical Center - Moses Hospital (Site 206-001) | Bronx | New York |
| United States | Montefiore Medical Center - Weiler campus (Site 206-003) | Bronx | New York |
| United States | NYU Brooklyn (301-033) | Brooklyn | New York |
| United States | Cooper University Hospital (Site 019-001) | Camden | New Jersey |
| United States | Medical University of South Carolina (Site 210-002) | Charleston | South Carolina |
| United States | Ralph H. Johnson VA Medical Center (Site 074-015) | Charleston | South Carolina |
| United States | University of Virginia Health System, University Hospital (Site 210-003) | Charlottesville | Virginia |
| United States | University of Illinois at Chicago (Site 008-012) | Chicago | Illinois |
| 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 | 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 | Public Health Institute at Denver Health (Site 017-004) | Denver | Colorado |
| United States | Henry Ford Health System (Site 014-001) | Detroit | Michigan |
| United States | Sinai-Grace Hospital (Site 205-005) | Detroit | Michigan |
| United States | Duke University Hospital (Site 301-006) | Durham | North Carolina |
| United States | Lutheran Medical Group (Site 301-010) | Fort Wayne | Indiana |
| United States | UCSF Fresno (Site 203-005) | Fresno | California |
| United States | University of Florida - Gainesville (Site 201-004) | Gainesville | Florida |
| United States | Penn State Health Milton S. Hershey Medical Center (Site 209-002) | Hershey | Pennsylvania |
| 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 | University of Mississippi Medical Center (Site 202-005) | Jackson | Mississippi |
| United States | The University of Kansas Hospital (Site 080-044) | Kansas City | Kansas |
| United States | Dartmouth-Hitchcock Medical Center (301-024) | Lebanon | New Hampshire |
| United States | University of Kentucky (Site 210-004) | Lexington | Kentucky |
| 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 | Mount Sinai Queens (Site 081-105) | Long Island City | New York |
| United States | CHRISTUS Good Shepherd Medical Center (Site 080-031) | Longview | Texas |
| 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 | William S. Middleton Memorial Veterans Hospital (074-030) | Madison | Wisconsin |
| United States | VA Northern California Health Care System (Site 074-023) | Mather | California |
| United States | Froedtert Memorial Lutheran Hospital (052-001) | Milwaukee | Wisconsin |
| United States | NYU Long Island (301-034) | Mineola | New York |
| 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 | West Virginia University Medicine | Morgantown | West Virginia |
| United States | Intermountain Medical Center (Site 211-001) | Murray | Utah |
| United States | Vanderbilt University Medical Center (Site 212-001) | Nashville | Tennessee |
| United States | Yale University (Site 025-001) | New Haven | Connecticut |
| United States | Mount Sinai Medical Center (Site 301-012) | New York | New York |
| United States | New York University Tisch Hospital (Site 301-013) | 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 | New Jersey Medical School Clinical Research Center (028-001) | Newark | New Jersey |
| United States | Hoag Memorial Hospital Presbyterian (Site 080-026) | Newport Beach | California |
| United States | University of Nebraska Medical Center (Site 080-045) | Omaha | Nebraska |
| United States | Orlando VA Medical Center (Site 074-032) | Orlando | Florida |
| United States | Veterans Affairs Palo Alto Health Care System (VAPAHCS) (Site 074-005) | Palo Alto | California |
| United States | Portland VA Health Care System (074-024) | Portland | Oregon |
| United States | St. Lawrence Health System (Site 301-029) | Potsdam | New York |
| United States | Rhode Island Hospital (Site 080-036) | Providence | Rhode Island |
| United States | The Miriam Hospital (Site 080-039) | Providence | Rhode Island |
| United States | Monument Health Rapid City Hospital (Site 213-005) | Rapid City | South Dakota |
| United States | Mayo Clinic (Site 054-001) | Rochester | Minnesota |
| United States | UC Davis Health (Site 203-004) | Sacramento | California |
| United States | Washington University School of Medicine (Site 003-001) | Saint Louis | Missouri |
| United States | Salem VA Medical Center (Site 074-014) | Salem | Virginia |
| United States | University of Utah Health (Site 211-002) | Salt Lake City | Utah |
| United States | UT Health San Antonio (Site 009-022) | San Antonio | Texas |
| United States | VA San Diego Healthcare System (Site 074-016) | San Diego | California |
| United States | San Francisco VAMC (Site 074-002) | San Francisco | California |
| United States | UCSF Medical Center at Mount Zion (203-007) | San Francisco | California |
| United States | University of California San Francisco (Site 203-001) | San Francisco | California |
| United States | Zuckerberg San Francisco General Hospital and Trauma Center (Site 213-007) | San Francisco | California |
| United States | CHRISTUS - St. Vincent (Site 080-051) | Santa Fe | New Mexico |
| United States | Harborview Medical Center (208-001) | Seattle | Washington |
| United States | Providence (Sacred Heart) (Site 213-004) | Spokane | Washington |
| United States | Baystate Medical Center (Site 201-001) | Springfield | Massachusetts |
| United States | Stanford University Hospital & Clinics (Site 203-003) | Stanford | California |
| United States | Tampa General Hospital (032-001) | Tampa | Florida |
| United States | Lundquist Institute for Biomedical Innovation (Site 066-002) | Torrance | California |
| 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 | Carle Foundation Hospital (Site 080-049) | Urbana | Illinois |
| United States | Kent County Memorial Hospital (080-048) | Warwick | Rhode Island |
| United States | MedStar Health Research Institute/MedStar Washington Hospital Center (Site 009-021) | Washington | District of Columbia |
| United States | Washington DC VA Medical Center (Site 009-004) | Washington | District of Columbia |
| United States | Wake Forest Baptist Health (Site 210-001) | Winston-Salem | North Carolina |
| United States | UMass Chan Medical School (Site 080-007) | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| University of Minnesota | National Institute of Allergy and Infectious Diseases (NIAID) |
United States, Argentina, Australia, Denmark, Georgia, Germany, Greece, Japan, Korea, Republic of, Nigeria, Puerto Rico, Singapore, South Africa, Spain, Thailand, Uganda, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Days to Recovery Scale assessed over 60 days (DRS-60) | DRS-60 is a version of the STRIVE clinical recovery scale (CRS) which combines time to recovery with non-recovered clinical state and death to an ordinal outcome.0 indicates best results, 60 represents recovered on Day 60, with not recovered by Day 60 coded as 61 and death (worst outcome) as 62. | 60 days post-intervention | |
| Secondary | mortality | proportion of participants who died by Day 60 | 60 days post-treatment | |
| Secondary | a 3-category ordinal outcome | the following categories: recovered (alive and at home at Day 60), alive and not recovered, and dead | 60 days post-treatment | |
| Secondary | time to recovery | 60 days post-treatment | ||
| Secondary | proportion of participants who died or required new invasive mechanical ventilation | 60 days post-treatment |
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