Aspirin will be investigated in the world’s largest clinical trial of treatments for patients hospitalised with COVID-19. The Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial is taking place in 176 hospital sites across the UK, and has so far recruited over 16,000 patients. Patients with COVID-19 are at higher risk of blood clots forming in their blood vessels. Platelets, small cell fragments in the blood that stop bleeding, seem to be hyperreactive in COVID-19 and may be involved in the clotting complications. Since aspirin is an antiplatelet agent, it may reduce the risk of blood clots in patients with COVID-19.
Professor Peter Horby, from the Nuffield Department of Medicine, co-Chief Investigator of the RECOVERY trial, said ‘We felt it was particularly important to add aspirin to the trial since there is a clear rationale for believing that it might be beneficial and it is safe, inexpensive and widely available. We are looking for medicines for COVID-19 that can be used immediately by anyone, anywhere in the world. We do not know if aspirin is such a medicine but we will find out.’
AstraZeneca Aims to Bring Non-U.S. Vaccine Data Before the FDA
AstraZeneca will start discussing emergency approval of its experimental COVID-19 vaccine with U.S. regulators once it has good trial data from Britain, South Africa and Brazil, as it has no indication the watchdog would favour U.S. data.If and when AstraZeneca reaches the first statistically reliable efficacy and safety results from those trials, based on more than 25,000 volunteers in total, it would present them to the U.S. Food and Drug Administration (FDA) even though any read-out from an ongoing U.S. trial will be months later.
“If you hit those thresholds we are going to have a conversation with them,” executive team member Mene Pangalos told Reuters. “What the FDA has signalled is what their expectations of data are for an approval,” he said, adding the company had not spoken to the U.S. watchdog about where the data should some from. The future of the U.S. trial would not be called into question by any successful non-U.S. trial result, Pangalos stressed.