AGILE: Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment

Our Vision is to shorten the time taken to identify safe, effective and affordable treatments for COVID-19. Our Mission is for AGILE to be the key link in the chain of accelerated drug development, evaluating potential candidate treatments for COVID-19 and advancing only the compounds most likely to be effective into large-scale clinical trials. Objectives include: 1. Establish a single UK-wide Phase I platform to accelerate the clinical evaluation of promising new treatments for COVID19, as a feeder programme for larger phase IIb/III trials 2. Implement a Bayesian adaptive platform design which can seamlessly evaluate the optimal dose, safety, tolerability and preliminary efficacy of potential COVID treatments, and flexibly match endpoints and study populations to drug action and anticipated deployment. 3. Develop a strong portfolio of promising compounds with potential for scalable deployment and affordable implementation, progressing at least 3 candidates for onward evaluation. 4. Work with the Department of Health to support Phase IIb/III trials in the UK, and to de-risk significant government investment in large-scale trials at a time when NHS resources are stretched beyond capacity.