Published: 08 December 2021
A first-of-its-kind clinical trial to investigate the effectiveness of new COVID-19 oral antiviral treatments - which can be safely taken at home - has begun enrolling participants today.
The NIHR-funded and supported, nationwide platform trial will rapidly assess the effectiveness of a range of novel, purpose-designed COVID-19 antivirals. These new orally administered 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 from the disease.
The Platform Adaptive trial of NOvel antiviRals for eArly treatMent of COVID-19 In the Community (PANORAMIC) is now open to participants from right across the UK.
People can join the study if they have a positive COVID-19 test, are within five days from the onset of symptoms - and are aged 50 and over, or between 18 to 49 years with underlying health conditions that make them clinically more vulnerable. All participants should have recorded a positive lateral flow (LFT) or PCR test within the past seven days.
The researchers will enrol 10,600 volunteers in total for each arm of the study. To enable the benefit of the treatment to be compared against standard care - 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 results from the 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.
Led by the University of Oxford, PANORAMIC will bring together GP practices, NHS 111, Test and Trace, care homes, pharmacies and other NHS and social care service providers UK-wide - who will actively identify potential participants, invite them to take part and support their participation.
People who receive a positive 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 tests positive for COVID-19 and 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. For participants randomised to the group that receives an antiviral treatment, medicines will be sent to people’s homes from an online pharmacy 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 that could help clinically vulnerable people with COVID-19 recover sooner, prevent the need for hospital admission and so ease the burden on the NHS. The UK Antivirals Taskforce has selected all treatments to be tested.
The first new 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. Additional new antiviral treatments will also be investigated through different arms of the trial platform, as and when they become available.
Professor Nick Lemoine, Medical Director of the NIHR 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 positive 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 will be able to link people with the trial; everyone who is eligible across the UK 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. The health services will then be able to rapidly get evidence-based treatments out to those sick with COVID 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 NIHR, led by Oxford University’s Primary Care Clinical Trials Unit, while delivery of the trial is supported by the NIHR Clinical Research Network.
Find out more
For further information, please visit: www.panoramictrial.org