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ACTIV-2/A5401: Adaptive Platform Treatment for Outpatients with COVID-19 (Adapt Out COVID)
Rationale: There is an urgent need for a platform to rapidly evaluate therapies in the outpatient setting, to prevent disease progression, and reduce serious complications of COVID-19 and transmission . ACTIV-2/A5401 is a phase II/III randomized, blinded, controlled adaptive platform trial to efficiently evaluate agents for the treatment of non-hospitalized persons with COVID-19. This will allow:
• comparison of multiple therapies with a common control group, when feasible, thus potentially requiring fewer participants than in independently conducted randomized controlled trials,
• continuous introduction of new promising agents as they become available,
• generation of separate effect size estimates for each therapy, and
• minimized downtime, with rapid movement of promising agents into phase III evaluation.
Additionally, the trial will facilitate the exploration of virologic endpoints as possible future primary endpoints in COVID-19 trials by assessing the correlation between changes in viral shedding and clinical outcomes.