Clinical trial for COVID-19 antiviral pill opens in Southampton

People across the south are being invited to take part in a trial of a “game-changing” antiviral pill to help combat COVID-19.

Molnupiravir is approved for use in the UK for people with mild to moderate COVID-19 symptoms who are at extra risk due to underlying health conditions. The international clinical trials used to make this decision included unvaccinated patients.

Now, a study to test the treatment in the wider community has opened at the NIHR Southampton Clinical Research Facility (CRF). The trial is part of the AGILE COVID-19 Drug Testing Initiative run by the NIHR Southampton Clinical Trials Unit (SCTU).

The trial is open to adults with laboratory confirmed COVID-19, who are within five days of symptom onset. It accepts those who have or haven’t been vaccinated.

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.”

Antiviral treatment for higher risk patients

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. This followed initial international trials carried out by the manufacturers in unvaccinated patients. Results 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.

Professor Gareth Griffiths, Director of the NIHR SCTU, said: “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.”

Participants needed until late February

Study samples will be analysed in the laboratory to further gain a better understanding of which patients and COVID-19 variants molnupiravir works in.

The trial has currently recruited 139 out of 180 participants from CRFs across the UK. It 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 (UHS) NHS Foundation Trust, said: “We are delighted that UHS and the Southampton CRF 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.”

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.uk

To find out more about AGILE, click here.

 

Image: Professor Christopher Edwards, Principal Investigator for AGILE in Southampton and Associate Director of the Southampton CRF.