STRIVE Trial 2 (INSIGHT 018B): Immune Modulation Strategy Trial (IM Strategy)
This COVID-19 treatment study was 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 were randomized to receive a one-time infusion of abatacept or matching placebo. Randomization was stratified by study site pharmacy and level of supplemental oxygen. The primary efficacy outcome assessed clinical recovery over 60 days of follow-up. The planned sample size was 1500 participants.