Cutting-edge COVID-19 trial will test combination of antiviral treatments

A “cutting-edge” clinical trial is testing whether a combination of antiviral treatments can prevent people with COVID-19 from developing serious infections.

Over the past few months, the number of COVID-19 cases in the UK has been rising rapidly, putting an enormous pressure on our already stretched health service.

“Despite high uptake of the COVID-19 vaccinations, the virus is still prevalent with many patients continuing to require hospital admission if they become seriously ill with the disease,” says Professor Saye Khoo, Chief Investigator for the AGILE drug testing platform.

“We have already seen successful clinical trials of single antiviral treatments for COVID-19, and now we want to see whether combining two different antivirals can reduce the number of people who develop a serious infection.”

Combining therapies

The trial is part of the AGILE Coronavirus Drug Testing Initiative, a UK-wide collaboration of research partners, led by the University of Liverpool and the NIHR Southampton Clinical Trials Unit, working to find potential new treatments for COVID-19 and fast-track them through early phase clinical trials.

It is the first trial to combine two different anti-viral treatments, molnupiravir and Paxlovid.

“Both of these treatments have already been shown to have some effect against COVID-19 disease in previous clinical trials,” says Dr Emma Knox, Senior Trial Manager at the Southampton Clinical Trials Unit. “This new trial will allow us to test the safety of combining the drugs and, if successful, will lead to a larger trial which would see this treatment being given to more people with COVID-19 to test how effective it is.”

Patients with confirmed COVID-19 and who are within five days of the onset of symptoms will be invited to take part in the trial, which is being conducted by the research teams at the NIHR Clinical Research Facility Network in Liverpool, Manchester and Southampton.

They will be closely monitored to see how taking both treatments together affects them, and whether there are any signs of the combination combatting the virus.

Professor Gareth Griffiths, Director of the Southampton Clinical Trials Unit and co-investigator for AGILE, says: “As we continue to see COVID-19 spread through the population and experience new waves of the disease, there is concern that the virus may eventually become resistant to current treatments, or that they may not be completely effective against future variants of COVID-19. We therefore hope that this first trial to combine antiviral therapies could help to increase the options we have to combat this virus in the future.”

The new trial is now open to patient recruitment at [insert trust name], with [insert other trust names] due to open in the coming weeks.

Results from a previous AGILE trial of molnupiravir alone were recently published in The Lancet and showed that the antiviral did have an effect against the COVID-19 virus in both vaccinated and unvaccinated populations, and against different variants of the disease. These results fed into the larger PANORAMIC trial, which also showed that the drug could reduce recovery time from COVID-19.