Nationwide launch for GP-based trial of COVID-19 therapies

Researchers from Oxford University have begun recruiting participants into the first clinical trial of potential COVID-19 therapies to take place in GP practices around the country.

The Platform Randomised trial of INterventions against COVID-19 in older peoPLE (PRINCIPLE) trial will involve hundreds of GP practices across the UK, and is one of three national priority clinical trials on COVID-19.

The trial has bagged funding of £1.7 million from the £24.6 million rapid research response funded by UK Research and Innovation (UKRI), and by the Department of Health and Social Care through the National Institute for Health Research (NIHR).

PRINCIPLE is designed to quickly assess different treatments that could stem the progression of COVID-19 symptoms in older people and help ease the burden on hospitals.

The researchers note that while most clinical trials for COVID-19 are focussed on providing treatment to hospital patients who already have serious symptoms, the PRINCIPLE trial seeks to identify treatments that can be prescribed by community-based GPs to slow or halt the progression of the disease and prevent the need for hospitalisation.

The trial will initially evaluate hydroxychloroquine, normally used to treat conditions such as malaria and arthritis, in patients at most risk of complications from COVID-19, but the antibiotic azithromycin will also soon be added to the trial, the researchers said.

PRINCIPLE, which is managed by Oxford University’s Primary Care Clinical Trials Unit, aims to recruit over 3,000 people at more than 100 GP practices, though this number will grow if additional treatments are introduced.

"What’s unique about the PRINCIPLE trial platform is that it’s so flexible," said chief investigator, Professor Chris Butler, Professor of Primary Care in the Nuffield Department of Primary Care Health Sciences, a part-time GP for the Cwm Taf Morgannwg University Health Board, and Fellow of Trinity College.

"By setting up a nationwide primary care research network across the NHS, we’re able to rapidly evaluate potential new treatments for COVID-19. This trial will allow us to make treatments that are proven to be effective as widely, and as rapidly available as possible.

"At the moment we really do not have enough information about whether any benefits from taking these medicines for COVID-19 outweigh any possible harms. That is why we urgently need to do a proper trial, so we have the information we need to guide the provision of best care for all."
 

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