Potentially Life-saving COVID-19 Antiviral Treatment Study Open for Recruitment in the UK

Zarrin Hossain

December 21, 2021

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) is set by the UK Antivirals Taskforce to trial Molnupiravir (Lagevrio) first. Molnupiravir was the first oral antiviral approved by the MHRA.

"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 Prof 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.

Eligibility Criteria

The study, led by the University of Oxford, working collaboratively with GP hubs and funded by the National Institute for Health Research (NIHR), will prioritise those at high risk who have tested PCR-positive 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 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 health 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 event experienced will be noted down by participants in a daily diary for 28 days, either through the website or communicated through 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.

Previous Trials

Commenting on how previous trials (e.g. the RECOVERY trial) compares with PANORAMIC, Prof Butler described previous trials to be 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 [previously done] 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."

Safety Concerns

Addressing the latest safety concerns surrounding molnupiravir and data showing its decrease in efficacy from 50% to 30%, Prof 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 alleviate some of the burden on the NHS," he concluded.

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