Southampton researchers to lead national COVID-19 antiviral treatment trial
Researchers at the University of Southampton will help lead a national trial of antiviral treatments for COVID-19.
Eligible residents across the south are being urged to take part in the first-of-its-kind clinical trial, which will investigate the effectiveness of new oral antiviral treatments for COVID-19 which can be taken safely at home.
The trial, known as PANORAMIC, will rapidly assess a range of purpose-designed antiviral treatments which could help clinically vulnerable people with COVID-19 in the community recover sooner, preventing the need for hospital admissions and easing the burden on the NHS.
These new antiviral treatments are intended for use in the very early stages of infection, by people in the community with COVID-19 who are at higher risk of complications.
Local people can join the study if they are aged 50 and over, or between 18 to 49 years with underlying health conditions that make them clinically more vulnerable. All participants also need to have had a positive COVID-19 test and be within five days of the onset of symptoms.
To enable the benefit of each treatment to be compared against standard care, a total of 10,600 volunteers across the UK are needed to take part in each arm of the study. Half of the participants will be randomly allocated to receive the antiviral treatment plus standard care, while the other half will receive standard care alone.
The PANORAMIC study brings together GP practices, NHS 111, Test and Trace, care homes, pharmacies and other NHS and social care service providers across the UK - who will actively identify potential participants, invite them to take part and support their participation.
Local people who meet the eligibility criteria can also sign-up to take part in the study directly through the trial website: www.panoramictrial.org
All participants will take part from their own homes, without needing to visit a clinic or a hospital. Participants randomised to the group that receives an antiviral treatment will have their medicines sent directly to their homes by courier. Participants will keep a daily diary for 28 days through the PANORAMIC website or receive a phone call from the trial team on days 7, 14 and 28 to speak about their symptoms and any NHS care they have needed.
PANORAMIC has been designed as a ‘platform clinical trial’, meaning it can rapidly evaluate several antiviral treatments, as and when they become available. The UK Antivirals Taskforce has selected all the treatments to be tested, the first of which will be molnupiravir (brand name, Lagevrio) - a COVID antiviral pill - which has already been licensed by the MHRA.
The results from this highest priority national study will provide a clearer understanding on how antivirals work in the UK population - which has a high vaccination rate - enabling the NHS to better plan how to make COVID-19 antivirals available for those who would benefit from them the most.
The trial’s Chief Investigator, Professor Chris Butler, Professor of Primary Care at Oxford University's Nuffield Department of Primary Care Health Sciences, said:
“It is early on in the illness, when people are still being cared for in the community, that treatments for COVID-19 could have their greatest benefit. So far, a lot of the research has focussed on finding out if well-known drugs can be repurposed to treat COVID-19. This new trial will test whether exciting, new antiviral treatments that are more specific to COVID-19 help people in the community recover faster and reduce the need for treatment in hospital.”
Professor Paul Little, Professor of Primary Care Research at the University of Southampton and Co-Chief Investigator of the trial, said:
“This is a vital trial addressing a major gap in our ability to treat patients who are at higher risk of serious COVID-19 illness in the community. Antiviral treatments that are quickly despatched to patients to take safely in their own homes could be an important way to manage the illness in more vulnerable patients, slow the spread of the virus, and keep hospital and ITU admissions down.
“The anti-viral drugs only work during the first 5 days of symptoms, so rapid assessment is needed. I would encourage anyone over the age of 50 (or under 50 with other major medical problems) who tests positive for COVID-19 to consider registering for this trial and help us find more ways to fight this illness.”
Dr Patrick Moore, GP and Associate Clinical Director of the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Wessex, said:
“Research has played a vital role in tackling the pandemic, but it would not be possible without volunteers. Across the south, we’ve had a fantastic response from members of the public who are keen to step forward and take part in trials. This trial will help us to gather vital evidence about treatments in the community to help those most at risk from COVID-19. If you’re over 50, or between 18 to 49 years with underlying health conditions, and have tested positive for COVID-19, I would encourage you to consider signing up to this trial.”
Professor Nick Lemoine, Medical Director of the NIHR CRN, said:
“When taken in the earliest stages of infection, these ground-breaking, purpose-designed, COVID-19 antiviral treatments hold the potential to greatly improve outcomes for patients most at risk from the disease. As orally-administered treatments, designed to be taken at home soon after the onset of symptoms, the drugs work by disrupting and preventing the virus from multiplying inside the body.
“Earlier trials have shown these new antivirals to be safe and effective in treating COVID-19. However more data is needed on how well they work in populations that are largely vaccinated - as we have in the UK. The PANORAMIC trial will rapidly generate the additional evidence needed for the NHS to roll-out this exciting new-generation of COVID-19 treatments, as quickly and safely as possible.”
The University of Southampton is partnering with the University of Oxford, several other UK universities, GPs, the NIHR and the NHS to help deliver this national priority trial at pace and scale across the UK.
PANORAMIC is funded and delivered by the National Institute for Health Research and led by Oxford University’s Primary Care Clinical Trials Unit.