TERMINATED

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

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Conditions

COVID-19

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-12-23
Study Completion:2025-10-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05605093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years.
  2. * Informed consent for trial participation.
  3. * Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection.
  4. * 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.
  5. * Onset of symptoms attributable to SARS-CoV2 infection occurred within 14 days before randomization.
  6. * Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection.
  1. * The patient is expected to be discharged from the hospital within the next 24 hours.
  2. * Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization.
  3. * Use of a strong CYP3A inducer within 14 days prior to enrollment
  4. * Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization.
  5. * Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life.
  6. * Expected inability or unwillingness to participate in study procedures.
  7. * In the opinion of the investigator, participation in a trial is not in the best interest of the patient.
  8. * Allergy to investigational agent or vehicle
  9. * Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622
  10. * Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure.
  11. * Known estimated glomerular filtration rate (eGRF) \<30 mL/min/1.73m 2
  12. * Continuous renal replacement therapy or chronic dialysis
  13. * Current pregnancy
  14. * Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent.
  15. * 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.
  16. * 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.
  17. * Inability to take investigational agent in tablet form by mouth.

Contacts and Locations

Principal Investigator

Cavan Reilly, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota
Jason Baker, MD
STUDY_CHAIR
University of Minnesota

Study Locations (Sites)

University of Alabama Birmingham University Hospital (Site 213-002)
Birmingham, Alabama, 35233
United States
Banner University Medical Center Tucson (Site 206-004)
Tucson, Arizona, 85719
United States
Southern Arizona VA Healthcare System (Site 074-009)
Tucson, Arizona, 85723
United States
UCSF Fresno (Site 203-005)
Fresno, California, 93721
United States
VA Loma Linda Healthcare System (Site 074-017)
Loma Linda, California, 92357
United States
MemorialCare Health System (Site 066-003
Long Beach, California, 90806
United States
VA Long Beach Healthcare System (Site 074-026)
Long Beach, California, 90822
United States
Cedars-Sinai Medical Center (Site 208-002)
Los Angeles, California, 90048
United States
Ronald Reagan UCLA Medical Center (Site 203-002)
Los Angeles, California, 90095
United States
VA Northern California Health Care System (Site 074-023)
Mather, California, 95655
United States
Hoag Memorial Hospital Presbyterian (Site 080-026)
Newport Beach, California, 92663
United States
Veterans Affairs Palo Alto Health Care System (VAPAHCS) (Site 074-005)
Palo Alto, California, 94304
United States
UC Davis Health (Site 203-004)
Sacramento, California, 95817
United States
VA San Diego Healthcare System (Site 074-016)
San Diego, California, 92161
United States
Zuckerberg San Francisco General Hospital and Trauma Center (Site 213-007)
San Francisco, California, 94110
United States
UCSF Medical Center at Mount Zion (203-007)
San Francisco, California, 94115
United States
San Francisco VAMC (Site 074-002)
San Francisco, California, 94121
United States
University of California San Francisco (Site 203-001)
San Francisco, California, 94143
United States
Stanford University Hospital & Clinics (Site 203-003)
Stanford, California, 94305
United States
Lundquist Institute for Biomedical Innovation (Site 066-002)
Torrance, California, 90502
United States
Rocky Mountain Regional VA Medical Center (Site 074-010)
Aurora, Colorado, 80045
United States
University of Colorado Hospital (Site 204-001)
Aurora, Colorado, 80045
United States
Public Health Institute at Denver Health (Site 017-004)
Denver, Colorado, 80204
United States
Yale University (Site 025-001)
New Haven, Connecticut, 06510
United States
MedStar Health Research Institute/MedStar Washington Hospital Center (Site 009-021)
Washington D.C., District of Columbia, 20010
United States
Washington DC VA Medical Center (Site 009-004)
Washington D.C., District of Columbia, 20422
United States
University of Florida - Gainesville (Site 201-004)
Gainesville, Florida, 32610
United States
Miami VA Healthcare System (Site 074-003)
Miami, Florida, 33125
United States
Orlando VA Medical Center (Site 074-032)
Orlando, Florida, 32827
United States
Tampa General Hospital (032-001)
Tampa, Florida, 33606
United States
John H. Stroger, Jr. Hospital of Cook County (Site 080-046)
Chicago, Illinois, 60612
United States
University of Illinois at Chicago (Site 008-012)
Chicago, Illinois, 60612
United States
Carle Foundation Hospital (Site 080-049)
Urbana, Illinois, 61801
United States
Lutheran Medical Group (Site 301-010)
Fort Wayne, Indiana, 46804
United States
The University of Kansas Hospital (Site 080-044)
Kansas City, Kansas, 66160
United States
University of Kentucky (Site 210-004)
Lexington, Kentucky, 40536
United States
NIH Clinical Center (Site 080-043)
Bethesda, Maryland, 20892
United States
Massachusetts General Hospital (202-002)
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center (Site 202-001)
Boston, Massachusetts, 02215
United States
Baystate Medical Center (Site 201-001)
Springfield, Massachusetts, 01199
United States
UMass Chan Medical School (Site 080-007)
Worcester, Massachusetts, 01655
United States
VA Ann Arbor Healthcare System (Site 074-028)
Ann Arbor, Michigan, 48105
United States
Henry Ford Health System (Site 014-001)
Detroit, Michigan, 48202
United States
Sinai-Grace Hospital (Site 205-005)
Detroit, Michigan, 48235
United States
Hennepin Healthcare Research Institute (Site 027-001)
Minneapolis, Minnesota, 55415
United States
M Health Fairview University of Minnesota Medical Center (Site 112-001)
Minneapolis, Minnesota, 55455
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic (Site 054-001)
Rochester, Minnesota, 55905
United States
University of Mississippi Medical Center (Site 202-005)
Jackson, Mississippi, 39216
United States
Washington University School of Medicine (Site 003-001)
St Louis, Missouri, 63110
United States
University of Nebraska Medical Center (Site 080-045)
Omaha, Nebraska, 68198
United States
Dartmouth-Hitchcock Medical Center (301-024)
Lebanon, New Hampshire, 03756
United States
Cooper University Hospital (Site 019-001)
Camden, New Jersey, 08103
United States
Hackensack Meridian Health (Site 301-030)
Hackensack, New Jersey, 07601
United States
New Jersey Medical School Clinical Research Center (028-001)
Newark, New Jersey, 07103
United States
University of New Mexico Hospital (Site 213-008)
Albuquerque, New Mexico, 87106
United States
CHRISTUS - St. Vincent (Site 080-051)
Santa Fe, New Mexico, 87505
United States
NYU Brooklyn (301-033)
Brooklyn, New York, 11220
United States
New York Presbyterian Queens (003-005)
Flushing, New York, 11355
United States
Mount Sinai Queens (Site 081-105)
Long Island City, New York, 11102
United States
NYU Long Island (301-034)
Mineola, New York, 11501
United States
New York University Tisch Hospital (Site 301-013)
New York, New York, 10016
United States
Mount Sinai Medical Center (Site 301-012)
New York, New York, 10029
United States
NYC Health + Hospital Harlem (Site 003-003)
New York, New York, 10037
United States
Weill Cornell Clinical Research Unit (065-001)
New York, New York, 10065
United States
St. Lawrence Health System (Site 301-029)
Potsdam, New York, 13676
United States
Lincoln Medical Center (Site 003-016)
The Bronx, New York, 10451
United States
Montefiore Medical Center - Moses Hospital (Site 206-001)
The Bronx, New York, 10467
United States
Montefiore Medical Center - Weiler campus (Site 206-003)
The Bronx, New York, 10467
United States
James J. Peters VAMC (Site 023-003)
The Bronx, New York, 10468
United States
Duke University Hospital (Site 301-006)
Durham, North Carolina, 27710
United States
Wake Forest Baptist Health (Site 210-001)
Winston-Salem, North Carolina, 27157
United States
University of Cincinnati Medical Center (Site 207-003)
Cincinnati, Ohio, 45219
United States
Cleveland Clinic Foundation (Site 207-001)
Cleveland, Ohio, 44195
United States
Ohio State University Wexner Medical Center (Site 207-004)
Columbus, Ohio, 43210
United States
Portland VA Health Care System (074-024)
Portland, Oregon, 97239
United States
Penn State Health Milton S. Hershey Medical Center (Site 209-002)
Hershey, Pennsylvania, 17033
United States
Rhode Island Hospital (Site 080-036)
Providence, Rhode Island, 02903
United States
The Miriam Hospital (Site 080-039)
Providence, Rhode Island, 02906
United States
Kent County Memorial Hospital (080-048)
Warwick, Rhode Island, 02886
United States
Ralph H. Johnson VA Medical Center (Site 074-015)
Charleston, South Carolina, 29401
United States
Medical University of South Carolina (Site 210-002)
Charleston, South Carolina, 29425
United States
Monument Health Rapid City Hospital (Site 213-005)
Rapid City, South Dakota, 57701
United States
Vanderbilt University Medical Center (Site 212-001)
Nashville, Tennessee, 37212
United States
Hendrick Medical Center (Site 080-014)
Abilene, Texas, 79601
United States
CHRISTUS Spohn Shoreline Hospital (Site 080-001)
Corpus Christi, Texas, 78405
United States
Baylor, Scott and White Health (301-003)
Dallas, Texas, 75246
United States
Parkland Health and Hospital Systems (Site 084-002)
Dallas, Texas, 75390
United States
UT Southwestern Medical Center (Site 084-001)
Dallas, Texas, 75390
United States
Houston Methodist Hospital (Site 301-028)
Houston, Texas, 77030
United States
MEDVAMC (Site 074-006)
Houston, Texas, 77030
United States
University of Texas Health Science Center (Site 203-006)
Houston, Texas, 77030
United States
CHRISTUS Good Shepherd Medical Center (Site 080-031)
Longview, Texas, 75601
United States
UT Health San Antonio (Site 009-022)
San Antonio, Texas, 78229
United States
Intermountain Medical Center (Site 211-001)
Murray, Utah, 84107
United States
University of Utah Health (Site 211-002)
Salt Lake City, Utah, 84108
United States
University of Virginia Health System, University Hospital (Site 210-003)
Charlottesville, Virginia, 22908
United States
Salem VA Medical Center (Site 074-014)
Salem, Virginia, 24153
United States
Harborview Medical Center (208-001)
Seattle, Washington, 98104
United States
Providence (Sacred Heart) (Site 213-004)
Spokane, Washington, 99204
United States
West Virginia University Medicine (301-023)
Morgantown, West Virginia, 26506
United States
William S. Middleton Memorial Veterans Hospital (074-030)
Madison, Wisconsin, 53705
United States
Froedtert Memorial Lutheran Hospital (052-001)
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Cavan Reilly, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota
  • Jason Baker, MD, STUDY_CHAIR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-23
Study Completion Date2025-10-28

Study Record Updates

Study Start Date2022-12-23
Study Completion Date2025-10-28

Terms related to this study

Additional Relevant MeSH Terms

  • COVID-19