Britain starts recruiting for real-world COVID antiviral trial

LONDON (Reuters) – British researchers on Wednesday started recruitment for a clinical trial to test antiviral COVID-19 treatments for use in people early on in the disease who are at higher risks of complications, starting with Merck’s molnupiravir.

Britain became the first country in the world to approve molnupiravir, which was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in November. Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) recommended the antiviral pill for use in people with mild to moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age diabetes, and heart disease.

The government said in October it had secured 480,000 courses of the Merck drug, and after its approval, officials said that its rollout would originally be through a trial. “It is early on in the illness, when people are still being cared for in the community, that treatments for COVID-19 could have their greatest benefit,” chief investigator on the trial Professor Chris Butler said. “This new trial will test whether exciting, new antiviral treatments that are more specific to COVID-19 help people in the community recover faster and reduce the need for treatment in hospital.”

The University of Oxford, which is leading the trial, said the first treatment to be investigated would be molnupiravir, also known as Lagevrio, but that it would be able to rapidly evaluate several antiviral treatments over time. Researchers said that while earlier trials had shown new antivirals to be safe and highly effective in treating COVID-19, the new trial would help generate data on how well they work in populations that have high vaccine coverage, and would inform the broader rollout of the drug.

The study will look to recruit 10,600 people to test whether molnupiravir reduces the need for people to be admitted to hospital.