Global regulators have reached a consensus on acceptable primary endpoints in randomised controlled clinical trials for treatments of COVID-19.
In the International Coalition of Medicines Regulatory Authorities’ (ICMRA) latest meeting, the goal was to agree acceptable endpoints which would “facilitate rapid and consistent implementation of future clinical trials for COVID-19 medicines across the world.”
For hospitalised patients with moderate or severe COVID-19, the endpoints were proposed to inform clinical benefit and support regulatory decision-making. The endpoints included time to recovery through day 28/29, clinical status as improvement of two points on an ordinal scale, mortality within 28 days after randomisation and time to sustained recovery up to day 90.
For patients with mild cases of COVID-19 in outpatient settings, the ICMRA agreed that mortality may not be suitable as a primary endpoint. Other appropriate endpoints included rate of progression to severe disease and proportion of patients not hospitalised at a pre-specified time point.
Regulators also noted that future changes in the standard of care for treatment of COVID-19 must be considered when designing future studies.
For detailed information on the agreed endpoints, click here.