Strategies and Treatments for Respiratory Infections &; Viral Emergencies (STRIVE): Shionogi Protease Inhibitor
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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.
Sites / Locations
- University of Alabama Birmingham University Hospital (Site 213-002)Recruiting
- Banner University Medical Center Tucson (Site 206-004)Recruiting
- Southern Arizona VA Healthcare System (Site 074-009)Recruiting
- UCSF Fresno (Site 203-005)Recruiting
- VA Loma Linda Healthcare System (Site 074-017)Recruiting
- MemorialCare Health System (Site 066-003Recruiting
- VA Long Beach Healthcare System (Site 074-026)Recruiting
- Ronald Reagan UCLA Medical Center (Site 203-002)Recruiting
- VA Northern California Health Care System (Site 074-023)Recruiting
- Veterans Affairs Palo Alto Health Care System (VAPAHCS) (Site 074-005)Recruiting
- UC Davis Health (Site 203-004)Recruiting
- VA San Diego Healthcare System (Site 074-016)Recruiting
- Zuckerberg San Francisco General Hospital and Trauma Center (Site 213-007)Recruiting
- San Francisco VAMC (Site 074-002)Recruiting
- University of California San Francisco (Site 203-001)Recruiting
- Stanford University Hospital & Clinics (Site 203-003)Recruiting
- Lundquist Institute for Biomedical Innovation (Site 066-002)Recruiting
- Rocky Mountain Regional VA Medical Center (Site 074-010)Recruiting
- University of Colorado Hospital (Site 204-001)Recruiting
- Public Health Institute at Denver Health (Site 017-004)Recruiting
- MedStar Health Research Institute/MedStar Washington Hospital Center (Site 009-021)Recruiting
- Washington DC VA Medical Center (Site 009-004)Recruiting
- University of Florida - Gainesville (Site 201-004)Recruiting
- Orlando VA Medical Center (Site 074-032)Recruiting
- University of Illinois at Chicago (Site 00-012)Recruiting
- Carle Foundation Hospital (Site 080-049)Recruiting
- Lutheran Medical Group (Site 301-010)Recruiting
- The University of Kansas Hospital (Site 080-044)Recruiting
- University of Kentucky (Site 210-004)Recruiting
- NIH Clinical Center (Site 080-043)Recruiting
- Beth Israel Deaconess Medical Center (Site 202-001)Recruiting
- Baystate Medical Center (Site 201-001)Recruiting
- UMass Chan Medical School (Site 080-007)Recruiting
- VA Ann Arbor Healthcare System (Site 074-028)Recruiting
- Henry Ford Health System (Site 014-001)Recruiting
- Hennepin Healthcare Research Institute (Site 027-001)Recruiting
- M Health Fairview University of Minnesota Medical Center (Site 112-001)Recruiting
- University of MinnesotaRecruiting
- Mayo Clinic (Site 054-001)Recruiting
- University of Mississippi Medical Center (Site 202-005)Recruiting
- Washington University School of Medicine (Site 003-001)Recruiting
- University of Nebraska Medical Center (Site 080-045)Recruiting
- CHRISTUS - St. Vincent (Site 080-051)Recruiting
- Lincoln Medical Center (Site 003-016)Recruiting
- Montefiore Medical Center - Moses Hospital (Site 206-001)Recruiting
- Montefiore Medical Center - Weiler campus (Site 206-003)Recruiting
- James J. Peters VAMC (Site 023-003)Recruiting
- Mount Sinai Queens (Site 081-105)Recruiting
- New York University Tisch Hospital (Site 301-013)Recruiting
- Mount Sinai Medical Center (Site 301-012)Recruiting
- NYC Health + Hospital Harlem (Site 003-003)Recruiting
- St. Lawrence Health System (Site 301-029)Recruiting
- Duke University Hospital (Site 301-006)Recruiting
- Wake Forest Baptist Health (Site 210-001)Recruiting
- University of Cincinnati Medical Center (Site 207-003)Recruiting
- Cleveland Clinic Foundation (Site 207-001)Recruiting
- Penn State Health Milton S. Hershey Medical Center (Site 209-002)Recruiting
- Rhode Island Hospital (Site 080-036)Recruiting
- The Miriam Hospital (Site 080-039)Recruiting
- Ralph H. Johnson VA Medical Center (Site 074-015)Recruiting
- Medical University of South Carolina (Site 210-002)Recruiting
- Monument Health Rapid City Hospital (Site 213-005)Recruiting
- Vanderbilt University Medical Center (Site 212-001)Recruiting
- Hendrick Medical Center (Site 080-014)Recruiting
- CHRISTUS Spohn Shoreline Hospital (Site 080-001)Recruiting
- Parkland Health and Hospital Systems (Site 084-002)Recruiting
- UT Southwestern Medical Center (Site 084-001)Recruiting
- Houston Methodist Hospital (Site 301-028)Recruiting
- MEDVAMC (Site 074-006)Recruiting
- University of Texas Health Science Center (Site 203-006)Recruiting
- CHRISTUS Good Shepherd Medical Center (Site 080-031)Recruiting
- UT Health San Antonio (Site 009-022)Recruiting
- Intermountain Medical Center (Site 211-001)Recruiting
- University of Utah Health (Site 211-002)Recruiting
- University of Virginia Health System, University Hospital (Site 210-003)Recruiting
- Salem VA Medical Center (Site 074-014)Recruiting
- Providence (Sacred Heart) (Site 213-004)Recruiting
- Westmead Hospital (Site 612-058)Recruiting
- The Alfred Hospital (Site 612-017)Recruiting
- Aalborg Hospital (Site 625-005)Recruiting
- Rigshospitalet, CHIP (Site 625-006)Recruiting
- Bispebjerg Hospital (Site 625-013)Recruiting
- Herlev/Gentofte Hospital (Site 625-012)Recruiting
- Nordsjaellands Hospital, Hillerod (Site 625-009)Recruiting
- Hvidovre University Hospital, Department of Infections Diseases (Site 625-001)Recruiting
- AIDS and Clinical Immunology Research Center (Site 627-201)Recruiting
- Fujita Health University Hospital (Site 612-105)Recruiting
- Center Hospital of the National Center for Global Health and Medicine (Site 612-101)Recruiting
- Seoul National University Bundang Hospital (Site 612-904)Recruiting
- Seoul St. Mary's Hospital (Site 612-903)Recruiting
- Chung-Ang University Hospital (Site 612-902)Recruiting
- Tan Tock Seng Hospital (Site 612-201)Recruiting
- Chulalongkorn University and The HIV-NAT (Site 613-001)Recruiting
- Central City Clinical Hospital of Ivano-Frankivsk City Council (Site 627-302)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
S-217622 plus standard of care (SOC)
placebo plus standard of care (SOC)
Study investigational agent (S-217622) 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.
Study investigational placebo (S-217622) 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.