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Trinity Professorial Fellow Chris Butler has been awarded £1.7 million in funding for the first clinical trial of potential COVID-19 treatments to take place in GP practices.
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. It has just been awarded a £1.7 million share of 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 will enable researchers to rapidly evaluate different treatments that could stem the progression of COVID-19 symptoms in older people and help ease the burden on hospitals. Unlike many other clinical trials for COVID-19, which are mostly focussed on providing treatment to those who already have serious symptoms and are admitted to hospital, the PRINCIPLE trial looks 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. Only those at most risk of complications from COVID-19 will be eligible to join the trial via participating GP surgeries.
Professor Butler’s team will initially test if the anti-malarial drug hydroxychloroquine can reduce the need for people to go to hospital or speed up their recovery. They will recruit patients aged over 65 years (or aged 50-64 years with underlying health conditions), who consult in primary care and have COVID-19 symptoms. The trial aims to recruit over 3,000 people, and has been designed to be flexible, so new suitable treatments can be added into the trial when these become available.
Professor Butler, the trial’s chief investigator, said: ‘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. However, we do not want to give people medication that does not work and may simply put them at unnecessary risk of side effects.
‘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.’
More than 100 GP practices are already actively recruiting participants into PRINCIPLE, with further practices coming on board on a daily basis. PRINCIPLE is managed by Oxford University’s Primary Care Clinical Trials Unit.
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