Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)
Purpose
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.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Placebo Comparator 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. |
|
Recruiting Locations
Banner University Medical Center Tucson (Site 206-004)
Tucson, Arizona 85719
Tucson, Arizona 85719
Southern Arizona VA Healthcare System (Site 074-009)
Tucson, Arizona 85723
Tucson, Arizona 85723
UCSF Fresno (Site 203-005)
Fresno, California 93721
Fresno, California 93721
VA Loma Linda Healthcare System (Site 074-017)
Loma Linda, California 92357
Loma Linda, California 92357
Contact:
VA ICC
VA ICC
MemorialCare Health System (Site 066-003
Long Beach, California 90806
Long Beach, California 90806
Cedars-Sinai Medical Center (Site 208-002)
Los Angeles, California 90048
Los Angeles, California 90048
VA Northern California Health Care System (Site 074-023)
Mather, California 95655
Mather, California 95655
Hoag Memorial Hospital Presbyterian (Site 080-026)
Newport Beach, California 92663
Newport Beach, California 92663
UC Davis Health (Site 203-004)
Sacramento, California 95817
Sacramento, California 95817
Contact:
Nashville ICC
Nashville ICC
VA San Diego Healthcare System (Site 074-016)
San Diego, California 92161
San Diego, California 92161
Zuckerberg San Francisco General Hospital and Trauma Center (Site 213-007)
San Francisco, California 94110
San Francisco, California 94110
UCSF Medical Center at Mount Zion (203-007)
San Francisco, California 94115
San Francisco, California 94115
San Francisco VAMC (Site 074-002)
San Francisco, California 94121
San Francisco, California 94121
University of California San Francisco (Site 203-001)
San Francisco, California 94143
San Francisco, California 94143
Contact:
Nashville ICC
Nashville ICC
Lundquist Institute for Biomedical Innovation (Site 066-002)
Torrance, California 90502
Torrance, California 90502
Rocky Mountain Regional VA Medical Center (Site 074-010)
Aurora, Colorado 80045
Aurora, Colorado 80045
University of Colorado Hospital (Site 204-001)
Aurora, Colorado 80045
Aurora, Colorado 80045
Yale University (Site 025-001)
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Miami VA Healthcare System (Site 074-003)
Miami, Florida 33125
Miami, Florida 33125
Orlando VA Medical Center (Site 074-032)
Orlando, Florida 32827
Orlando, Florida 32827
John H. Stroger, Jr. Hospital of Cook County (Site 080-046)
Chicago, Illinois 60612
Chicago, Illinois 60612
University of Illinois at Chicago (Site 008-012)
Chicago, Illinois 60612
Chicago, Illinois 60612
The University of Kansas Hospital (Site 080-044)
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Massachusetts General Hospital (202-002)
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Beth Israel Deaconess Medical Center (Site 202-001)
Boston, Massachusetts 02215
Boston, Massachusetts 02215
University of Minnesota
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
University of Mississippi Medical Center (Site 202-005)
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Dartmouth-Hitchcock Medical Center (301-024)
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
Hackensack Meridian Health (Site 301-030)
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
University of New Mexico Hospital (Site 213-008)
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87106
Lincoln Medical Center (Site 003-016)
Bronx, New York 10451
Bronx, New York 10451
Montefiore Medical Center - Moses Hospital (Site 206-001)
Bronx, New York 10467
Bronx, New York 10467
Montefiore Medical Center - Weiler campus (Site 206-003)
Bronx, New York 10467
Bronx, New York 10467
New York Presbyterian Queens (003-005)
Flushing, New York 11355
Flushing, New York 11355
Mount Sinai Queens (Site 081-105)
Long Island City, New York 11102
Long Island City, New York 11102
Contact:
New York ICC
New York ICC
New York University Tisch Hospital (Site 301-013)
New York, New York 10016
New York, New York 10016
Mount Sinai Medical Center (Site 301-012)
New York, New York 10029
New York, New York 10029
Weill Cornell Clinical Research Unit (065-001)
New York, New York 10065
New York, New York 10065
Wake Forest Baptist Health (Site 210-001)
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
University of Cincinnati Medical Center (Site 207-003)
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Ohio State University Wexner Medical Center (Site 207-004)
Columbus, Ohio 43210
Columbus, Ohio 43210
Portland VA Health Care System (074-024)
Portland, Oregon 97239
Portland, Oregon 97239
Penn State Health Milton S. Hershey Medical Center (Site 209-002)
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
Kent County Memorial Hospital (080-048)
Warwick, Rhode Island 02886
Warwick, Rhode Island 02886
Medical University of South Carolina (Site 210-002)
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Vanderbilt University Medical Center (Site 212-001)
Nashville, Tennessee 37212
Nashville, Tennessee 37212
Contact:
Nashville ICC
Nashville ICC
CHRISTUS Spohn Shoreline Hospital (Site 080-001)
Corpus Christi, Texas 78405
Corpus Christi, Texas 78405
Parkland Health and Hospital Systems (Site 084-002)
Dallas, Texas 75390
Dallas, Texas 75390
UT Southwestern Medical Center (Site 084-001)
Dallas, Texas 75390
Dallas, Texas 75390
Houston Methodist Hospital (Site 301-028)
Houston, Texas 77030
Houston, Texas 77030
Intermountain Medical Center (Site 211-001)
Murray, Utah 84107
Murray, Utah 84107
University of Utah Health (Site 211-002)
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
University of Virginia Health System, University Hospital (Site 210-003)
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Salem VA Medical Center (Site 074-014)
Salem, Virginia 24153
Salem, Virginia 24153
Contact:
VA ICC
VA ICC
Harborview Medical Center (208-001)
Seattle, Washington 98104
Seattle, Washington 98104
West Virginia University Medicine
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
VA Caribbean Health Care (074-033)
San Juan, Puerto Rico 00921-3201
San Juan, Puerto Rico 00921-3201
More Details
- NCT ID
- NCT05605093
- Status
- Recruiting
- Sponsor
- University of Minnesota