Published: 25 January 2022
A ground-breaking, NIHR-funded clinical trial investigating new antiviral treatments for COVID-19 that can be safely taken at home has become the UK’s fastest ever recruiting interventional clinical trial delivered through primary care.
The Platform Adaptive trial of NOvel antiviRals for eArly treatMent of COVID-19 In the Community (PANORAMIC) study has already enrolled over four thousand five hundred participants from every corner of the UK, in just seven weeks.
However the research team still needs thousands more participants to achieve the trial’s first recruitment target and generate the evidence to enable the antiviral drug molnupiravir to be clinically deployed to those who will benefit as soon as possible.
The PANORAMIC study was established to assess and rapidly produce the evidence needed to enable a new generation of potentially revolutionary, orally administered COVID-19 antiviral treatments to be rolled out to those most at risk from the disease.
The study opened for recruitment and began enrolling participants on 8 December 2021 - with a total of 4,684 participants recruited as of 25 January 2022 (and over 15,000 people screened for recruitment). No other primary care interventional studies delivered in the UK have ever achieved this level of recruitment, within such a short timescale.
The nation-wide platform trial aims to recruit over 10,600 participants to each of its treatment arms - with the antiviral molnupiravir (already licensed by the MHRA) the first investigational medicinal product to be assessed.
Prof Nick Lemoine, Medical Director of the NIHR Clinical Research Network said:
“The pace and scale at which this study has been rolled out – and the sheer volume of participants screened and enrolled in just seven weeks is phenomenal. It’s testament to the incredible hard work of our GP and research colleagues across the whole of the United Kingdom - who have pulled together to deliver this national priority study at unparalleled speed.
“PANORAMIC is one of the most important COVID-19 trials of recent times. It will rapidly produce the evidence needed to make these game-changing antiviral drugs widely available to the people who need them most. It’s also by far the world’s largest trial on molnupirvair (the first treatment to be assessed), and will provide vital information about how well this new COVID-19 antiviral pill works in at-risk groups, within a predominantly vaccinated population.”
Prof Chris Butler, co-Chief Investigator of the PANORAMIC study said:
“Despite all the amazing support already given to the PANORAMIC study, we need even more people in the early stages of their COVID illness to urgently share their experiences with us. This will help us rapidly find out who will benefit most from the new treatments, so they can be given to the right people when they get sick.
“We encourage GPs and all health and social care professions across the country to let your patients know about the opportunity to contribute to this vital study. We also urge everyone eligible who tests positive to consider signing up, directly through the website. By doing so they will be directly joining the hunt for new treatments to speed recovery and reduce pressure on our NHS.”
As well as the GPs and their teams involved in delivering the study through the PANORAMIC GP hubs - all GPs, pharmacists and primary and social care care providers have a hugely important role to play in signposting their patients to the study and encouraging people with a recent COVID-19 diagnosis to take part and potentially access exciting new antiviral treatments.
People who test positive and meet the eligibility criteria can sign up directly via the study website (www.panoramictrial.org) or by calling 0808 156 0017.
All participants take part from the comfort of their own homes – with the study treatment delivered by courier and no face-to-face visits required. To take part, participants need to have had a positive COVID-19 test (either a lateral flow or PCR test), and be within five days of symptom onset on enrolment.
Eligible participants are randomly allocated to the treatment arm (receiving a five day course of the antiviral medication), or to the standard care arm – enabling a direct comparison of efficacy between those who receive the intervention, and those who receive usual care. The study needs to compare outcomes for those who do and who do not take the treatments to be able to find out who will benefit the most from the treatment.
The current range of antiviral treatments are only effective for COVID-19 when taken in the early stages of infection. One of the key challenges faced by the research team concerns the need to quickly identify and recruit participants who have tested positive for COVID, and are within five days from the start of their symptoms.
The innovative study design used in PANORAMIC enables participants to be identified by a network of GP hubs and spokes, as well as the central research team - and then contacted, screened and enrolled. Participants who are randomly allocated to the treatment arm then have their medication immediately shipped to their homes by courier - so that patients can begin taking the treatments the very next day.
As a platform trial, PANORAMIC has also laid the foundation to enable other exciting antiviral drugs to be rapidly assessed through the study - as soon as they become available - accelerating the development of promising new COVID-19 treatments which will benefit people around the world.
The PANORAMIC study is funded by the NIHR, run by the University of Oxford and delivered in partnership with the NIHR, devolved administrations and GPs/primary care health professionals across the whole of the United Kingdom.
Find out more or sign up to take part:
Find out more about the PANORAMIC trial or sign up to take part at: www.panoramictrial.org