STRIVE Trial 1 (INSIGHT 018A): Shionogi Protease Inhibitor (S-217622)
This COVID-19 treatment study was designed to evaluate the safety and efficacy of S-217622, an anti-SARS-CoV-2 3C-like protease inhibitor developed by Shionogi & Co. Ltd, when given in addition to standard of care in patients hospitalized for medical management of COVID-19. The primary efficacy outcome assessed clinical recovery over 60 days. Participants were randomized to receive a 5-day course of oral S-217622 or a 5-day course of matching oral placebo in addition to standard of care. The standard of care will be determined by local established guidelines and may include additional direct-acting antivirals (e.g., remdesivir) and immunomodulatory treatments. The planned sample size is 1500 participants.