Researchers have today started recruiting participants for a first-of-its-kind clinical trial to test novel antiviral COVID-19 treatments for use early on in the illness by people in the community with COVID-19 and those who are at higher risk of complications.
The trial is led by the University of Oxford, partnering with the National Institute for Health Research (NIHR) and working with colleagues in several UK universities including the University of Liverpool, and the NHS UK-wide.
The Platform Adaptive trial of NOvel antiviRals for eArly treatMent of COVID-19 In the Community (PANORAMIC) is a national priority trial, and will be open to participants from across the UK.
PANORAMIC has been designed as a ‘platform clinical trial’, meaning it can rapidly evaluate several antiviral treatments over time 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 Antiviral 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 already been licensed by the MHRA.
People can join the study if they, are aged 50 and over, aged between 18 to 49 years with underlying health conditions that make them clinically more vulnerable, or have been unwell with COVID-19 for less than five days. All participants should have recorded a positive PCR test within the past seven days.
Participants will receive either the anti-viral treatment plus the current standard care, or the current standard of care without the new antiviral treatment. Around 5,300 people will be recruited to each group – up to 10,600 volunteers in total will be needed for testing whether the first novel antiviral in the study reduces the need for people to be admitted to hospital.
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.
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.”
The trial will also assess the effectiveness of the treatments on reducing shedding of the virus, as well as preventing the spread of COVID-19 by offering treatment to some household contacts of participants.
Professor Butler said: “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.”
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.
“Earlier trials have shown these oral new antivirals to be safe and highly 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 five 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.”
Professor Mahendra Patel, the trial’s Pharmacy and Inclusion and Diversity Lead, said: “PANORAMIC will be working closely with pharmacists and their teams across settings to help play a crucial role in raising the awareness of the trial UK-wide and in supporting greater recruitment of volunteers from disadvantaged and diverse backgrounds.”
Professor Saye Khoo, from the University of Liverpool, said: “The availability of antiviral tablets given early in SARS-CoV-2 infection to prevent development of severe disease marks a new chapter in our fight against COVID 19. In a week dominated by the spread of the Omicron variant it is also a timely reminder that we need every weapon at our disposal: antivirals have an increasingly important role as this story unfolds.
“Molnupiravir is a drug first tested in the UK by the Liverpool-led AGILE consortium. We quickly determined the correct dose for use in COVID 19 which was subsequently utilised by trials of the drug across the world. AGILE is the UK’s early phase platform, designed to support large late-phase trials and our contribution to the evalution of drug safety of molnupiravir and other antivirals in PANORAMIC attests to the success of this approach.”
PANORAMIC is led by Oxford University’s Primary Care Clinical Trials Unit, funded by the National Institute for Health Research (NIHR), while delivery of the trial is supported by the NIHR Clinical Research Network.
For further information, please visit www.panoramictrial.org