ClinicalTrials.gov record
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)
ClinicalTrials.gov ID: NCT05605093
Public ClinicalTrials.gov record NCT05605093. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05605093
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 602 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 23, 2022 (Actual)
- Primary completion
- Oct 28, 2025 (Actual)
- Completion
- Oct 28, 2025 (Actual)
- Last update posted
- Sep 24, 2026
2022 – 2025
United States locations
- U.S. sites
- 103
- U.S. states
- 36
- U.S. cities
- 78
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham University Hospital (Site 213-002) | Birmingham | Alabama | 35233 | — |
| Banner University Medical Center Tucson (Site 206-004) | Tucson | Arizona | 85719 | — |
| Southern Arizona VA Healthcare System (Site 074-009) | Tucson | Arizona | 85723 | — |
| UCSF Fresno (Site 203-005) | Fresno | California | 93721 | — |
| VA Loma Linda Healthcare System (Site 074-017) | Loma Linda | California | 92357 | — |
| MemorialCare Health System (Site 066-003 | Long Beach | California | 90806 | — |
| VA Long Beach Healthcare System (Site 074-026) | Long Beach | California | 90822 | — |
| Cedars-Sinai Medical Center (Site 208-002) | Los Angeles | California | 90048 | — |
| Ronald Reagan UCLA Medical Center (Site 203-002) | Los Angeles | California | 90095 | — |
| VA Northern California Health Care System (Site 074-023) | Mather | California | 95655 | — |
| Hoag Memorial Hospital Presbyterian (Site 080-026) | Newport Beach | California | 92663 | — |
| Veterans Affairs Palo Alto Health Care System (VAPAHCS) (Site 074-005) | Palo Alto | California | 94304 | — |
| UC Davis Health (Site 203-004) | Sacramento | California | 95817 | — |
| VA San Diego Healthcare System (Site 074-016) | San Diego | California | 92161 | — |
| Zuckerberg San Francisco General Hospital and Trauma Center (Site 213-007) | San Francisco | California | 94110 | — |
| UCSF Medical Center at Mount Zion (203-007) | San Francisco | California | 94115 | — |
| San Francisco VAMC (Site 074-002) | San Francisco | California | 94121 | — |
| University of California San Francisco (Site 203-001) | San Francisco | California | 94143 | — |
| Stanford University Hospital & Clinics (Site 203-003) | Stanford | California | 94305 | — |
| Lundquist Institute for Biomedical Innovation (Site 066-002) | Torrance | California | 90502 | — |
| Rocky Mountain Regional VA Medical Center (Site 074-010) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital (Site 204-001) | Aurora | Colorado | 80045 | — |
| Public Health Institute at Denver Health (Site 017-004) | Denver | Colorado | 80204 | — |
| Yale University (Site 025-001) | New Haven | Connecticut | 06510 | — |
| MedStar Health Research Institute/MedStar Washington Hospital Center (Site 009-021) | Washington D.C. | District of Columbia | 20010 | — |
| Washington DC VA Medical Center (Site 009-004) | Washington D.C. | District of Columbia | 20422 | — |
| University of Florida - Gainesville (Site 201-004) | Gainesville | Florida | 32610 | — |
| Miami VA Healthcare System (Site 074-003) | Miami | Florida | 33125 | — |
| Orlando VA Medical Center (Site 074-032) | Orlando | Florida | 32827 | — |
| Tampa General Hospital (032-001) | Tampa | Florida | 33606 | — |
| John H. Stroger, Jr. Hospital of Cook County (Site 080-046) | Chicago | Illinois | 60612 | — |
| University of Illinois at Chicago (Site 008-012) | Chicago | Illinois | 60612 | — |
| Carle Foundation Hospital (Site 080-049) | Urbana | Illinois | 61801 | — |
| Lutheran Medical Group (Site 301-010) | Fort Wayne | Indiana | 46804 | — |
| The University of Kansas Hospital (Site 080-044) | Kansas City | Kansas | 66160 | — |
| University of Kentucky (Site 210-004) | Lexington | Kentucky | 40536 | — |
| NIH Clinical Center (Site 080-043) | Bethesda | Maryland | 20892 | — |
| Massachusetts General Hospital (202-002) | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center (Site 202-001) | Boston | Massachusetts | 02215 | — |
| Baystate Medical Center (Site 201-001) | Springfield | Massachusetts | 01199 | — |
| UMass Chan Medical School (Site 080-007) | Worcester | Massachusetts | 01655 | — |
| VA Ann Arbor Healthcare System (Site 074-028) | Ann Arbor | Michigan | 48105 | — |
| Henry Ford Health System (Site 014-001) | Detroit | Michigan | 48202 | — |
| Sinai-Grace Hospital (Site 205-005) | Detroit | Michigan | 48235 | — |
| Hennepin Healthcare Research Institute (Site 027-001) | Minneapolis | Minnesota | 55415 | — |
| M Health Fairview University of Minnesota Medical Center (Site 112-001) | Minneapolis | Minnesota | 55455 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic (Site 054-001) | Rochester | Minnesota | 55905 | — |
| University of Mississippi Medical Center (Site 202-005) | Jackson | Mississippi | 39216 | — |
| Washington University School of Medicine (Site 003-001) | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center (Site 080-045) | Omaha | Nebraska | 68198 | — |
| Dartmouth-Hitchcock Medical Center (301-024) | Lebanon | New Hampshire | 03756 | — |
| Cooper University Hospital (Site 019-001) | Camden | New Jersey | 08103 | — |
| Hackensack Meridian Health (Site 301-030) | Hackensack | New Jersey | 07601 | — |
| New Jersey Medical School Clinical Research Center (028-001) | Newark | New Jersey | 07103 | — |
| University of New Mexico Hospital (Site 213-008) | Albuquerque | New Mexico | 87106 | — |
| CHRISTUS - St. Vincent (Site 080-051) | Santa Fe | New Mexico | 87505 | — |
| NYU Brooklyn (301-033) | Brooklyn | New York | 11220 | — |
| New York Presbyterian Queens (003-005) | Flushing | New York | 11355 | — |
| Mount Sinai Queens (Site 081-105) | Long Island City | New York | 11102 | — |
| NYU Long Island (301-034) | Mineola | New York | 11501 | — |
| New York University Tisch Hospital (Site 301-013) | New York | New York | 10016 | — |
| Mount Sinai Medical Center (Site 301-012) | New York | New York | 10029 | — |
| NYC Health + Hospital Harlem (Site 003-003) | New York | New York | 10037 | — |
| Weill Cornell Clinical Research Unit (065-001) | New York | New York | 10065 | — |
| St. Lawrence Health System (Site 301-029) | Potsdam | New York | 13676 | — |
| Lincoln Medical Center (Site 003-016) | The Bronx | New York | 10451 | — |
| Montefiore Medical Center - Moses Hospital (Site 206-001) | The Bronx | New York | 10467 | — |
| Montefiore Medical Center - Weiler campus (Site 206-003) | The Bronx | New York | 10467 | — |
| James J. Peters VAMC (Site 023-003) | The Bronx | New York | 10468 | — |
| Duke University Hospital (Site 301-006) | Durham | North Carolina | 27710 | — |
| Wake Forest Baptist Health (Site 210-001) | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati Medical Center (Site 207-003) | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Foundation (Site 207-001) | Cleveland | Ohio | 44195 | — |
| Ohio State University Wexner Medical Center (Site 207-004) | Columbus | Ohio | 43210 | — |
| Portland VA Health Care System (074-024) | Portland | Oregon | 97239 | — |
| Penn State Health Milton S. Hershey Medical Center (Site 209-002) | Hershey | Pennsylvania | 17033 | — |
| Rhode Island Hospital (Site 080-036) | Providence | Rhode Island | 02903 | — |
| The Miriam Hospital (Site 080-039) | Providence | Rhode Island | 02906 | — |
| Kent County Memorial Hospital (080-048) | Warwick | Rhode Island | 02886 | — |
| Ralph H. Johnson VA Medical Center (Site 074-015) | Charleston | South Carolina | 29401 | — |
| Medical University of South Carolina (Site 210-002) | Charleston | South Carolina | 29425 | — |
| Monument Health Rapid City Hospital (Site 213-005) | Rapid City | South Dakota | 57701 | — |
| Vanderbilt University Medical Center (Site 212-001) | Nashville | Tennessee | 37212 | — |
| Hendrick Medical Center (Site 080-014) | Abilene | Texas | 79601 | — |
| CHRISTUS Spohn Shoreline Hospital (Site 080-001) | Corpus Christi | Texas | 78405 | — |
| Baylor, Scott and White Health (301-003) | Dallas | Texas | 75246 | — |
| Parkland Health and Hospital Systems (Site 084-002) | Dallas | Texas | 75390 | — |
| UT Southwestern Medical Center (Site 084-001) | Dallas | Texas | 75390 | — |
| Houston Methodist Hospital (Site 301-028) | Houston | Texas | 77030 | — |
| MEDVAMC (Site 074-006) | Houston | Texas | 77030 | — |
| University of Texas Health Science Center (Site 203-006) | Houston | Texas | 77030 | — |
| CHRISTUS Good Shepherd Medical Center (Site 080-031) | Longview | Texas | 75601 | — |
| UT Health San Antonio (Site 009-022) | San Antonio | Texas | 78229 | — |
| Intermountain Medical Center (Site 211-001) | Murray | Utah | 84107 | — |
| University of Utah Health (Site 211-002) | Salt Lake City | Utah | 84108 | — |
| University of Virginia Health System, University Hospital (Site 210-003) | Charlottesville | Virginia | 22908 | — |
| Salem VA Medical Center (Site 074-014) | Salem | Virginia | 24153 | — |
| Harborview Medical Center (208-001) | Seattle | Washington | 98104 | — |
| Providence (Sacred Heart) (Site 213-004) | Spokane | Washington | 99204 | — |
| West Virginia University Medicine (301-023) | Morgantown | West Virginia | 26506 | — |
| William S. Middleton Memorial Veterans Hospital (074-030) | Madison | Wisconsin | 53705 | — |
| Froedtert Memorial Lutheran Hospital (052-001) | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 84 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05605093, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 24, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05605093 live on ClinicalTrials.gov.