The PANORAMIC study aims to investigate the efficacy of oral COVID-19 antivirals in those at high risk who have tested positive for COVID-19
A new, UK-wide COVID-19 oral antiviral treatment trial for individuals at high risk has launched in England, aiming to investigate the efficacy of oral COVID-19 antivirals.
The Platform Adaptive trial of NOvel antiviRals for eArly treatMent of COVID-19 In the Community (PANORAMIC) study is set to trial molnupiravir first. Molnupiravir was the first oral antiviral treatment for COVID-19 to be approved by the Medicines and Healthcare products Regulatory Agency.
‘We’re hoping that the information gained from PANORAMIC will allow the NHS to figure out how and to whom these drugs should be prioritised,’ said Professor Chris Butler, PANORAMIC’s chief investigator.
‘We are hopeful that these agents will be robust over a long period of time, but we do know from other areas that the potential for resistance is something one has to be aware of. These are questions you can’t really understand, measure, or get answers for without actually using the agents themselves,’ added Eddie Gray, Chair of the UK Antivirals Taskforce.
The study—led by the University of Oxford, working collaboratively with GP hubs and funded by the National Institute for Health Research—will prioritise those at high risk of severe symptoms who are positive on polymerase chain reaction (PCR) testing for COVID-19.
The eligibility criteria include people who are symptomatic, are within 5 days of testing positive, and are aged 50 years and over or aged 18–49 years with comorbidities that make them clinically vulnerable.
People who are interested can enrol directly through the study website, or they will be contacted by the study team or a local healthcare professional if they have received a positive PCR result.
In England, approximately 60 GP hubs will be available to refer potential participants to enrol into the study. Systems in Wales, Scotland, and Northern Ireland have also been put into place for enrolment, such as remote medical teams, health boards, and self-referrals.
People who are pregnant or breastfeeding are not eligible, and pregnancy tests will be provided to confirm this before starting the trial.
Once enrolled, participants will be randomised into two groups—one receiving standard care plus a course of the oral antiviral, and the other group receiving standard care alone.
Any symptom or adverse events experienced will be noted down by participants in a daily diary for 28 days, either through the website or via a phone call on days 7, 14, and 28.
‘We are estimating that around 10,600 people will need to be recruited per antiviral to generate the data required,’ said Professor Butler.
Commenting on how previous trials (for example, the RECOVERY trial) compare with PANORAMIC, Professor Butler described them as being of a ‘fairly small scale’, highlighting that ‘they do not give us information about the effectiveness of these drugs in a largely vaccinated population’, or ‘whether these drugs could play a role in post-exposure prophylaxis’.
Also commenting, Dr David Lowe, Consultant Clinical Immunologist at University College London, said: ‘It may be that these antivirals are less prone to suffering resistance with novel variants; we don’t know that for sure, but that may well be the case.’
Mr Gray added: ‘These trials and the phase-3 studies [undertaken previously] essentially started at the very early days of vaccination starting, and the entry criteria and results are all in unvaccinated patients, and we now are a very highly vaccinated population.
‘Therefore, the question of how we best deploy them, who are the people most likely to get the most significant benefit, and how do we manage the use of the antivirals alongside other potential options in those patients are questions we would like to fully understand in our own system.
‘We are now launching the antivirals in an environment where the health service itself is under extreme pressure as a function of Omicron, and the frontline people who we would traditionally rely on for identification of patients and distribution of antivirals are up to their eyeballs in very high priority matters.’
Addressing the latest safety concerns surrounding molnupiravir, for which data show a decrease in efficacy from 50% to 30%, Professor Butler said: ‘A relative benefit of 30% reduction in hospitalisation compared with the interim finding of 50% really emphasises the need for a national trial to confirm what kind of benefit we might see in this context.’
‘The quicker those eligible sign up to the study, the quicker the recruitment target is met for the study and the trial produces results, enabling well-informed, wider deployment of antivirals and [alleviating] some of the burden on the NHS,’ he concluded.
This article originally appeared on Medscape, part of the Medscape Professional Network.
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