Ground-breaking COVID-19 antiviral treatment trial opens to recruitment in East Midlands
Local GPs and healthcare professionals have today begun enrolling participants across the East Midlands 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, prevent the need for hospital admission and ease 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 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 from the East Midlands and right across the UK - who will actively identify potential participants, invite them to take part and support their participation.
Taking part is easy. 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 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 treatments to be tested. The first treatment to be investigated through the trial 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.
Dr Simon Royal, NIHR CRN East Midlands Primary Care Specialty Lead, said:
“Research has already enabled us to make enormous strides in our efforts to reduce the spread of COVID-19 and improve the outcomes of people infected. It is hoped that these new antiviral treatments could be another important tool for the NHS.
“I would urge anyone in the East Midlands who receives a positive PCR test to consider stepping forward to take part in this study, if you meet the criteria. By doing so you will be playing a vital role in helping experts find new ways to tackle the symptoms of COVID-19.”
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 the East Midlands 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 the East Midlands who are participating in the trial, as they will be helping health services rapidly get evidence-based treatments out to those sick with COVID and who are at greatest risk of complications.”
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: https://www.panoramictrial.org