Trial of “Game-changing” COVID-19 treatment opens at University Hospital Southampton
People across the south are being invited to take part in a clinical trial of a “game-changing” antiviral pill to help combat COVID-19.
Molnupiravir recently hit the headlines when it was approved for use in the UK for people with mild to moderate COVID-19 symptoms who are at extra risk from the virus due to underlying health conditions. The clinical trials used to make this decision were international trials including unvaccinated patients.
Now, a trial to test the treatment in the wider community has opened at the NIHR Southampton Clinical Research Facility (CRF) at University Hospital Southampton as part of the AGILE COVID-19 Drug Testing Initiative run by the NIHR Southampton Clinical Trials Unit.
The trial is open to adults with laboratory confirmed COVID-19, who are within 5 days of symptom onset, and accepts those who have or haven’t been vaccinated.
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Professor Christopher Edwards, Principal Investigator for AGILE in Southampton and Associate Director of the Southampton CRF, said: “Despite the huge success of the NHS COVID-19 vaccination programme, we still need to find treatments for people who do contract the virus to prevent them developing more serious disease and reduce hospital admissions. Having a tablet, which is easy to administer and is effective against the virus is game-changing, and we are excited to be involved in the AGILE trial of molnupiravir.”
Molnupiravir works by interfering with the virus’ replication and preventing it from multiplying. This keeps virus levels low in the body and therefore reduces the severity of the disease.
The Medicines and Healthcare products Regulatory Agency (MHRA) approved the use of molnupiravir at the start of November, after initial international trials carried out by the manufacturers in unvaccinated patients showed the drug is safe and effective at reducing the risk of hospital admission and death in people at higher risk of complications from COVID-19.
The AGILE phase II trial of 180 participants is evaluating the safety and optimal dose of the drug in a wider population of patients with early symptomatic infection who are both vaccinated and unvaccinated.
It is fantastic that molnupiravir has been approved for use in vulnerable members of the community. However, the previous trials which led to this decision were carried out in unvaccinated people at the start of the pandemic and we need to understand more about who could benefit from molnupiravir and how it works, for example does it work as well in those with Omicron. If the clinical and laboratory results support its use in the wider community, including for those without pre-existing health conditions, these results will feed into the larger GP based trials, such as PANORAMIC, currently being opened across the UK.
Samples collected from participants will be analysed in the laboratory to further gain a better understanding of which patients and COVID-19 variants molnupiravir works in, in the hope it is a suitable a drug for everyone in the community to access as soon as they are found to have COVID-19. The trial has currently recruited 139 out of 180 participants from CRFs from across the UK and has opened at Southampton CRF with the hope of completing recruitment by the end of February.
Paul Grundy, Chief Medical Officer at University Hospital Southampton NHS Foundation Trust, said:
“We are delighted that UHS and the Southampton Clinical Research Facility are involved in the AGILE trial of molnupiravir. Southampton has been at the forefront of much of the UK’s COVID-19 research with our vaccine and treatment trials, and it is fantastic to see our staff continuing to make a significant contribution to ongoing research in these exceptionally challenging times. By working together with our partners at the Southampton Clinical Trials Unit on the continued development of longer-lasting and effective treatments, we hope we can further neutralise the threat of COVID-19 for everyone in the future.”
The national AGILE COVID-19 Drug Testing Initiative aims to rapidly identify therapies that have the potential to treat COVID-19 and bring them into early phase clinical trials. AGILE is led by researchers at the NIHR Southampton Clinical Trials Unit at the University of Southampton in collaboration with the University of Liverpool and other partners and working alongside the UK Clinical Research Facility network.
To find out more about this trial and taking part, please contact the AGILE team at the Southampton CRF on 07469 565 895 or email agile@uhs.nhs.net
To find out more about AGILE, click here.
Watch a video on the AGILE Coronavirus Drug-Testing Initiative
Notes for editors
The NIHR Southampton Clinical Trials Unit (CTU) 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 Clinical Research Facility (CRF) is based at University Hospitals Southampton, and is one of 19 NIHR clinical research facilities networked across the UK, giving superb access to research expertise and infrastructure. The CRF is where the latest scientific developments first enter the clinic, both from our own laboratories and from leading companies. Visit the CRF website.
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 COVID19 therapeutics across the UK CRF Network. Visit the AGILE website.