Fig. 1: Study schematic for I-SPY COVID.
From: Clinical trial design during and beyond the pandemic: the I-SPY COVID trial
The I-SPY COVID adaptive platform trial is a trial for patients with severe COVID-19 in which up to four agents are evaluated in parallel on a backbone of standard of care. Participants who do not wish to participate in the randomized cohort or who meet exclusion criteria are enrolled in an observational arm (per a waiver of informed consent from the Institutional Review Board) in which clinical and outcomes data are collected through medical records.
