STRIVE Trial 1 and 2

STRIVE 001 Platform

STRIVE (Strategies and Treatments for Respiratory Infections & Viral Emergencies; INSIGHT 018) aims to provide an agile research platform able to investigate strategies and treatments that may improve the health of patients hospitalized with a respiratory infection. The master protocol defines the scientific and operational framework of trials implemented as part of the platform. The specific design and conduct of each trial are described in trial-specific appendices. This approach is intended to pre-position infrastructure and to facilitate rapid and flexible response with high standards of scientific rigor to support the development of consensus for standard of care.

Project funding: National Institutes of Health (NIH)

Studies

STRIVE Trial 1 (INSIGHT 018A): Shionogi Protease Inhibitor (S-217622)

This COVID-19 treatment study is 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 will assess clinical recovery over 60 days. Participants will be 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.

For more details about the study, please go to ClinicalTrials.gov

Study type: Randomized Trial

Status: Completed

STRIVE Trial 2 (INSIGHT 018B): Immune Modulation Strategy Trial (IM Strategy)

This COVID-19 treatment study is designed to evaluate the safety and efficacy of adding a second immune modulator abatacept on top of a baseline therapy of a single immune modulator in participants hospitalized with COVID-19 and on conventional supplementary oxygen. Participants will be randomized to receive a one-time infusion of abatacept or matching placebo. Randomization will be stratified by study site pharmacy and level of supplemental oxygen. The primary efficacy outcome will assess clinical recovery over 60 days of follow-up. The planned sample size is 1500 participants.

For more details about the study, please go to ClinicalTrials.gov

Study type: Randomized Trial

Status: Completed