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AGILE CST-2
A Randomized, Multicentre, Seamless, Adaptive, Phase I/II Platform Study to Determine the optimal dose, Safety and Efficacy of EIDD-2801 for the Treatment of COVID-19.
AGILE is a multicentre, multi-arm, multi-dose, multi-stage open-label, adaptive, seamless phase I/II Bayesian randomised platform trial to determine the optimal dose, activity and safety of multiple candidate agents for the treatment of COVID-19.
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AGILE CST-3A
A Multicentre, Adaptive, Phase I trial to Determine the optimal dose, Safety and Efficacy of Nitazoxanide for the Treatment of COVID-19.
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AGILE CST-5
A Randomized, Multicentre, Seamless, Adaptive, Phase I/II Platform Study to Determine the Phase II dose of VIR-7832, and Evaluate the Safety and Efficacy of VIR-7831 and VIR-7832 for the Treatment of COVID-19.
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AGILE CST-6
A Randomized, Multicentre, Seamless, Adaptive, Phase I/II Platform Study to Determine the Phase II dose and to Evaluate the Safety and Efficacy of intravenous (IV) Favipiravir for the Treatment of COVID-19
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AGILE CST-8
A Randomized, Multicentre, Seamless, Adaptive, Phase I Platform Study of a combination of Molnupiravir and Paxlovid® for the Treatment of COVID-19.
The AGILE study allows for the assessment of many candidates at different doses, with the ability to add candidates as they are identified or drop them as their evaluation is completed. Promising candidates will move to an external trial for further evaluation in the phase II/III setting.
Each candidate will be evaluated in its own trial (Candidate-Specific Trial - CST), randomising between candidate and control with 2:1 allocation in favour of the candidate. Each dose will be assessed for safety sequentially in cohorts of 6 patients. Once a phase II dose has been identified we will assess efficacy by seamlessly expanding into a larger cohort.
An AGILE Scientific Advisory Board will evaluate and prioritise candidate agents for inclusion in the study. Candidate-specific trial (CST) protocols will outline full details of each candidate trial.