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Cutting-edge COVID-19 trial opens in Southampton

Published: 24 January 2023

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.

Notes for editors

AGILE is an academic clinical trial platform led by the University of Liverpool and the NIHR Southampton Clinical Trial Unit, in partnership with researchers from the Liverpool Tropical School of Medicine and NIHR Liverpool and Broadgreen Clinical Research Facility. It has been established to enable the rapid clinical evaluation of potential COVID-19 therapeutics across the UK CRF Network. Visit the AGILE website

The Southampton Clinical Trials Unit (SCTU) is a National Institute for Health Research (NIHR) supported CTU with expertise in the design, conduct and analysis of multicentre, interventional clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. Visit the SCTU website

The NIHR Southampton BRC is a longstanding partnership between University Hospital Southampton NHS Foundation Trust (UHSFT) and the University of Southampton, working together to translate scientific discoveries into new treatments, diagnostics and medical technologies for patients. Southampton has spearheaded NIHR-funded nutrition and respiratory research since 2008. Major breakthroughs in deliberate allergen exposure and lifelong prevention of fractures have improved treatments and guidance for patients in the south and across the UK. Visit the BRC website.

University Hospital Southampton (UHS). Southampton General Hospital is the Trust’s largest location, with a great number of specialist services based here, ranging from neurosciences and oncology to pathology and cardiology. Emergency and critical care is provided in the hospital’s special intensive care units, operating theatres, acute medicine unit and emergency department (A&E), as well as the dedicated eye casualty. Southampton General also hosts outpatient clinics, diagnostic and treatment work, surgery, research, education and training, as well as providing day beds and longer stay wards for hundreds of patients. Visit the UHS R&D website.

The University of Southampton (UoS) drives original thinking, turns knowledge into action and impact, and creates solutions to the world’s challenges. We are among the top 100 institutions globally (QS World University Rankings 2023). Our academics are leaders in their fields, forging links with high-profile international businesses and organisations, and inspiring a 22,000-strong community of exceptional students, from over 135 countries worldwide. Through our high-quality education, the University helps students on a journey of discovery to realise their potential and join our global network of over 200,000 alumni.


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