A Multicenter, Adaptive, Randomized, Controlled Trial Platform to Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections: Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) - Shionogi Protease Inhibitor (S-217622)

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1520

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 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., 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. NOTE: the exclusion criterion for patients unable to take the oral formulation of S-217622 (or placebo) may be removed if stability testing supports enteral administration of crushed tablets. If available data supports enteral administration of S-217622 (or placebo), then this exclusion would be removed and patients unable to take oral tablets would be eligible, e.g., those on invasive mechanical ventilation or ECMO, Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization, 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

STRIVE Appendix E1: S-217622 (Ensitrelvir)

RecruitingPhase 3

Ohmagari Norio

Updated 4/1/2024