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 Genders
- 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
Vanderbilt University Medical Center (Site 212-001)
Nashville, Tennessee 37212
Nashville, Tennessee 37212
Contact:
Nashville ICC
Nashville ICC
More Details
- Status
- Recruiting
- Sponsor
- University of Minnesota