New clinical trial platform launched to accelerate COVID-19 treatments

The University of Liverpool, Liverpool School of Tropical Medicine and Southampton Clinical Trials Unit have launched an innovative COVID-19 drug testing platform, AGILE, in the hope of accelerating the development of the most promising therapies.

Developed by infectious diseases clinicians, clinical and preclinical pharmacologists, clinical trials specialists and statisticians, the clinical trials platform can test new drugs for COVID-19 and “identify faster than ever before” the compounds “which could be game changers” in the fight against the virus.

“In the ongoing COVID-19 pandemic, we need to find innovative ways to identify safe and effective treatments as soon as possible. The AGILE platform bridges the gap between preclinical drug discovery and large-scale testing, rapidly identifying drugs that have the best chance of success,” according to Professor Saye Khoo, chief investigator on AGILE at the University of Liverpool.

“Seeing the launch of this new platform to test brand new COVID-19 treatments is truly exciting given the impact that any effective treatment could have on the pandemic and restarting society. We are optimistic that AGILE will accelerate the development of treatments for COVID- 19, and also prepare us to respond quicker to future pandemics.”

AGILE is a “proof of confidence engine” that can treat COVID-19 patients for the first time with promising drugs that have been developed in laboratories around the world.

The trial is conducted at the Royal Liverpool University Hospital Clinical Research Unit, where treatment is carefully monitored throughout by an independent committee to ensure that it is safe to continue, and the first evidence about the effectiveness of the drug for treatment of COVID-19 is accumulated to determine if it should be fast-tracked into large-scale trials.

The platform's design means that this can be achieved much more rapidly than when using conventional development pathways for new drugs, so that successful drugs can advance quickly enough to have an impact on the current pandemic, according to the partners.

AGILE, which can test drugs suitable for newly-diagnosed patients at home, as well as patients in hospital, has full ethics and regulatory approval in the UK.

“Patient safety is our highest priority. We approved this trial, as it not only innovates in the early clinical trial process, which is crucial in the current pandemic, but it is also robust and safe, providing opportunities for more rapid progress towards suitable treatment options,” said Dr Siu Ping Lam, director of licensing, at the Medicines and Healthcare products Regulatory Agency (MHRA).

“We are delighted that such a platform, designed by UK clinicians and scientists, has the potential to change the future of clinical trials and global healthcare for the better.”

The first drug set to be trialled in AGILE has been developed by the US pharmaceutical company Ridgeback Biotherapeutics.

EIDD-2801 is an oral antiviral drug that, according to researchers, has shown promising results against coronavirus infections in preclinical studies.