Associated organisationsInfectious Diseases Institute Makerere University · Lancaster University · Liverpool School of Tropical Medicine · Royal Free London NHS Foundation Trust · Royal Liverpool and Broadgreen University Hospitals Trust · University of Liverpool · University of SouthamptonEurope PMC affiliations are not treated as award recipients or mapped locations.
Funding£3.1M
PeriodJul 2020 — Jan 2023
In plain English
AI plain-English summary
A new clinical trial platform called AGILE is now testing multiple experimental COVID-19 drugs in parallel, moving them from first-in-human use to finding the right dose for patients in a single, seamless process. Conventional drug trials are too slow for a pandemic. Each new medicine typically requires separate, sequential studies to establish safety and dosing before it can be tested for efficacy. AGILE replaces this stepwise approach with a single adaptive protocol that can evaluate several drug candidates at once, using small numbers of patients. The trial is designed to quickly eliminate drugs that are unlikely to work, and to funnel the most promising candidates into large-scale trials such as RECOVERY and SOLIDARITY. If AGILE succeeds, it could transform how rapidly new antiviral treatments reach patients during a pandemic. The platform is already approved by UK regulators and ethics bodies, and is recruiting COVID-19 patients in the community for early-stage testing of population-scalable antiviral drugs. The same adaptive design could be reused for future outbreaks, cutting months off the timeline from drug discovery to clinical evidence.
View original technical description
Conventional evaluation of new medicines is not fast enough for a pandemic. Our aim is to accelerate this process, rapidly identifying which drugs are safe and potentially effective treatments for COVID-19. AGILE is an innovative, multi-arm, multi-dose, multi-stage Phase I/IIa Bayesian adaptive platform protocol to evaluate experimental COVID-19 therapies, and to funnel plausible candidates into large Phase IIb/III trials such as RECOVERY and SOLIDARITY. We will efficiently eliminate candidates with little or no prospect of clinical success. AGILE will recruit COVID-19 patients into very early phase clinical studies, including first-in-human. The innovative design allows us to move seamlessly from first-in-human use to finding the optimal dose for COVID-19 patients. The trial is pragmatic (requiring only small numbers of patients), adaptive (so that the right drug is tested in the right group of COVID-19 patients, either in the community or in hospital) and statistically efficient (so that several drugs can be tested in parallel, making best use of a small number of patients). Our primary focus is population-scalable antiviral drugs for early treatment of COVID-19, for which we will recruit primarily in the community. AGILE has full regulatory and ethics approvals in the UK
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