Ground-breaking COVID-19 antiviral treatment trial opens to recruitment in Kent, Surrey and Sussex
Local GPs and healthcare professionals have today begun enrolling participants across Kent, Surrey and Sussex to a first-of-its-kind clinical trial investigating the effectiveness of new oral antiviral treatments for COVID-19 - which can be safely taken at home.
The Platform Adaptive trial of NOvel antiviRals for eArly treatMent of covid-19 In the Community (PANORAMIC) trial 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 from 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 practises, NHS 111, Test and Trace, care homes, pharmacies and other NHS and social care service providers from Kent, Surrey and Sussex and right across the UK - who will actively identify potential participants, invite them to take part and support their participation.
Local people who receive a positive PCR test for COVID-19 will be contacted by the trial team or a local healthcare professional, such as a GP or a research nurse, to consider enrolling in the study. Alternatively, anyone who meets 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 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-19 antiviral pill - which has already been licensed by the Medicines and Healthcare products Regulatory Agency (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.
Dr Paul Deffley, National Institute for Health Research Clinical Research Network Kent, Surrey and Sussex (NIHR CRN KSS) specialty lead for Primary Care and GP at Trinity Medical Centre, Hove said:
“We are so excited to be supporting this critical piece of research. Understanding how we reduce the severity of COVID-19 infections in the community is a critical step to helping us get back to a usual way of life. Antiviral medication plays a key role in that, and hence this trial is helping us understand the evidence to guide national policy.
“If you have a PCR positive result, speak to your GP or healthcare professional about taking part or visit the PANORAMIC website to sign up. In order to understand just how effective the antiviral medication is, we need people to start the medication as close to the onset of symptoms as possible.”
Professor Nick Lemoine, Medical Director of the National Institute for Health Research Clinical Research Network (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. But to do that, we need your help.
“If you have a PCR-confirmed COVID-19 test, are within 5 days of symptom onset - and meet the study eligibility criteria - we urge you to volunteer for this pivotal study. Participants take part from the comfort of their own homes and there is no need to visit a clinic or hospital. Visit the PANORAMIC website to sign up, or speak to your GP or healthcare professional about taking part.”
The trial’s Chief Investigator, Professor Chris Butler, Professor of Primary Care in the 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.
“All community health and social care providers in Kent, Surrey and Sussex will be able to link people with the trial. Everyone who is eligible in the area and the UK as a whole will be able to join PANORAMIC, and many will be able to do so from their own homes by participating online with support from their GPs and study team, with medicines sent directly to them at home.
“It’s vital that as many people as possible who are at higher risk from complications of COVID-19 join the trial so we can rapidly learn if exciting new treatments really do help people get better quicker and reduce pressures on the NHS. We are grateful to people in Kent, Surrey and Sussex who are participating in the trial, as they will be helping health services rapidly get evidence-based treatments out to those sick with COVID-19 and who are at greatest risk of complications.”
Deputy Chief Medical Officer for England Professor Jonathan Van-Tam said:
“Throughout this pandemic, we have rapidly identified and deployed some of the world’s best treatments for COVID-19 to UK patients - including dexamethasone, tocilizumab and sarilumab.
“Antivirals will be a vital intervention for years to come, helping to protect those that can’t mount the same antibody response to the vaccines.
“This is really positive news for the future of our response to COVID-19 - please sign up to the study if you’re eligible as soon as you can.”
The NIHR is partnering with the University of Oxford, several other UK universities, GPs and the NHS to help deliver this national priority trial at pace and scale across the United Kingdom.
PANORAMIC is funded by the National Institute for Health Research, led by Oxford University’s Primary Care Clinical Trials Unit, while delivery of the trial is supported by the NIHR Clinical Research Network.
For further information, please visit the PANORAMIC trial website.