Cutting-edge COVID-19 trial opens in Southampton

A cutting-edge trial, testing whether a combination of anti-viral treatments can prevent people with COVID-19 from developing serious infections, has opened in Southampton.

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.

Now, researchers at the Southampton Clinical Trials Unit and NIHR Southampton Biomedical Research Centre are looking at whether combining two different anti-viral treatments can reduce the number of people who develop a serious infection.

“We have already seen successful clinical trials of single antiviral treatments for COVID-19,” says Professor Gareth Griffiths, Director of the Southampton Clinical Trials Unit and an investigator in the respiratory theme of the BRC. “For unvaccinated patients, these can reduce the risk of hospitalisation and in those who are vaccinated they can shorten the duration of symptoms”.

“However, there is concern that the virus may eventually become resistant to these 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.”

 

Combining therapies

The trial is part of the AGILE drug testing platform, a UK-wide collaboration of research partners working to find potential new treatments for COVID-19 and fast-track them through early phase clinical trials.

“This trial is the first to combine two different anti-viral treatments, molnupiravir and Paxlovid,” says Dr Emma Knox, Senior Trial Manager at the Southampton Clinical Trials Unit and BRC. “Both of these treatments have already been shown to have some effect against COVID-19 disease in previous clinical trials. 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 5 days of the onset of symptoms are being invited to take part in the trial.

Professor Christopher Edwards is co-director of the NIHR Southampton Clinical Research Facility, based at University Hospital Southampton, where patients will come to be seen by the research team and given their initial dose of the trial treatment.

“We have already been involved in two of the previous AGILE trials, as well as other COVID-19 studies, and therefore have a great deal of expertise in this area of research. As the pandemic evolves continually, it remains important that we develop new ways to tackle COVID-19 as soon as people realise they have it, to prevent their infection getting worse and prevent hospitalisation.”

 

Working in collaboration

The running of this trial is part of a new collaboration between the Southampton Clinical Trials Unit and the NIHR Southampton Biomedical Research Centre (BRC) in respiratory clinical trials.

Both research groups have vast expertise in respiratory research and are now working together to develop the clinical trials of the future which will benefit patients in the NHS.

The NIHR Southampton BRC is part of the National Institute for Health and Care Research and hosted by University Hospital Southampton in partnership with the University of Southampton.

Professor Mike Grocott, Director of the NIHR Southampton BRC and Professor of Anaesthesia and Critical Care at the University of Southampton, said:

“We are delighted to be involved in this latest trial in the AGILE COVID-19 platform. The NIHR Southampton BRC is working closely with the Southampton Clinical Trials Unit to develop clinical trials in respiratory disease and critical care. Finding new ways to tackle the COVID-19 virus is extremely important to ensure we have treatments that are robust enough to meet the global challenges of the pandemic.”

This is the latest trial in the AGILE drug testing platform, a collaboration between the Southampton Clinical Trials Unit, University of Liverpool, Liverpool School of Tropical Medicine, the NIHR Clinical Research Facility UK Network, and other partners.

The trial opened first at University Hospital Southampton on Tuesday (24th), with Liverpool University Hospitals also opening on Thursday (26th) and Manchester due to open to patients 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.

To find out more about this trial and how to take part, please visit the AGILE website.