AGILE Phase IIIa Platform Trial to Quickly Test Multiple COVID-19 Treatments in Adults

What this Trial Is About

Researchers are evaluating multiple potential treatments for adults with COVID-19 through the AGILE platform, which is a flexible, multi-center, multi-arm, adaptive phase III clinical trial. This trial tests various candidate drugs for safety, optimal dosing, and activity, allowing new candidates to be added or dropped efficiently based on emerging data. Promising treatments identified here may move on to larger phase IIIII trials for further study. The trial includes several candidate-specific studies, each assessing different drugs such as EIDD-2801 molnupiravir, Nitazoxanide, VIR-7831 and VIR-7832, intravenous Favipiravir, combinations of Molnupiravir and Paxlovid, and ALG-097558 alone or combined with remdesivir. Treatments are given orally or intravenously with dosing schedules varying by candidate, including multiple daily doses over several days. Some candidates are compared with placebo or standard care, and dosing is adjusted based on safety data. This design allows seamless transition from phase I dose-finding to phase II efficacy evaluation. Participants will be assessed through clinical evaluations, laboratory tests, and monitoring of viral loads and symptoms over periods ranging from 7 to 29 days after randomization. Safety is closely monitored by reviewing adverse events and vital signs, while efficacy is measured by changes in clinical status, viral clearance, hospitalization rates, and other COVID-19 related outcomes. Participants are expected to comply with study procedures and attend clinic visits throughout the treatment and follow-up periods.

AGILE (Early Phase Platform Trial for COVID-19)