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

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.