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Cutting-edge COVID-19 trial opens in Southampton

Southampton researchers are trialling a new combination of two COVID-19 treatments.

The trial is being run by the Southampton Clinical Trials Unit (CTU). It involves researchers from the NIHR Southampton Biomedical Research Centre (BRC).

Participants will take two antiviral treatments at the same time to see if this can help prevent serious infection.

Increasing treatment options

Professor Gareth Griffiths is the Director of Southampton CTU and an investigator in the respiratory theme of the BRC. He is part of the team launching the trial.

"We have already seen successful clinical trials of single antiviral treatments for COVID-19,” says Prof Griffiths.

“They reduce the risk of hospitalisation for unvaccinated patients and can shorten the duration of symptoms for those who are vaccinated.

“However, there is concern that the virus may become resistant to these treatments, or they may not be effective against future variants.

“We 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. AGILE is a UK-wide collaboration of research partners. They aim to find new treatments for COVID-19 and fast-track them through early phase clinical trials.

“This trial is the first to combine two different antiviral treatments, molnupiravir and Paxlovid,” says Dr Emma Knox, Senior Trial Manager at Southampton CTU and BRC.

“Both treatments have already been shown to have some effect against COVID-19 in previous clinical trials.

“This new trial will allow us to test the safety of combining the drugs. If successful, it will lead to a larger trial involving more people to test how effective it is.”

Patients with confirmed COVID-19 will be invited to take part in the trial. This must be within five days of their symptoms starting.

Professor Christopher Edwards is co-director of the NIHR Southampton Clinical Research Facility (CRF). Patients will come to the CRF to be seen by the research team and get their initial dose of the trial treatment.

Prof Edwards said: “The CRF was involved in two previous AGILE trials, as well as other COVID-19 studies.

"As the pandemic evolves, it remains important that we develop new ways to tackle COVID-19 as soon as people know they have it. This can help prevent serious infections and hospitalisation.”

Working in collaboration

The trial is part of a new collaboration between the CTU and BRC in respiratory clinical trials. Both research groups are experts in respiratory research. They are working together to develop future clinical trials which will benefit patients in the NHS.

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

Professor Mike Grocott, Director of the NIHR Southampton BRC, said:

“The BRC are delighted to be involved in this latest trial in the AGILE COVID-19 platform.

“We are working with the CTU to develop clinical trials in respiratory disease and critical care.

“Finding new ways to tackle the COVID-19 virus is extremely important. This will help 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. It is a collaboration between Southampton CTU, University of Liverpool, Liverpool School of Tropical Medicine, the NIHR Clinical Research Facility UK Network, and other partners.

Results from a previous AGILE trial were recently published in The Lancet. They showed that molnupiravir is an effective treatment for both vaccinated and unvaccinated populations, and against different variants of the disease.