Oxford University is conducting a nationwide drugs trial which could prevent people aged over 50 who are vulnerable to developing serious Covid-19 symptoms and is recruiting now.
Using drugs that have treated malaria and arthritis, the Platform Randomised trial of Interventions against COVID-19 in Older peoPLE (PRINCIPLE) trial is testing the pre-existing medication hydroxychloroquine in the first phase over a seven-day course. The aim is to slow or halt the progression of Covid-19 and prevent the need for hospital admission.
More than 500 GP practices across the country are recruiting people aged 50 and over with underlying health conditions, or people aged over 65 regardless of underlying health conditions, into the trial. From this week the trial is now also screening participants online. This means that regardless of which GP surgery they are registered with, older people with coronavirus symptoms can now pre-screen for the trial at home via an online questionnaire to see whether they can be included. The antibiotic azithromycin will soon be added to the trial.
PRINCIPLE, the first trial of Covid-19 treatments to take place in primary care, and one of the UK Government’s four national priority platform trials on the disease, is trialling a number of low-risk treatments recommended by an expert panel advising the Chief Medical Officer for England. The effectiveness of these treatments will be compared to the current best available care.
Professor Chris Butler, the trial’s chief investigator, said: ‘The PRINCIPLE trial platform is enabling us to rapidly evaluate potential treatments for Covid-19 in older people who are most at risk of serious complications from the illness.
‘With enough people recruited, this trial will give us the vital information we need to understand whether existing drugs can help people recover sooner and at home, without needing to be admitted to hospital – a significant milestone in the course of this pandemic. As soon as we find that any one of the drugs in our trial is making a critical difference to people’s health, we want it to be part of clinical practice as soon as it can be introduced.’
Dr Rebecca Clark, a GP, said: ‘It is vital that we urgently identify treatments that can help people to get better more quickly and keep them out of hospital. As a practice running the trial locally, I have been amazed at how straightforward the enrolment process has been for our patients.’
Professor Chris Whitty, Chief Medical Officer, said: ‘The Government is working with researchers to find proven, effective treatments for Covid-19. This PRINCIPLE trial is a vital part of this research effort and it’s being scaled up by GP surgeries across the country.
‘I would urge anyone who is contacted to take part in this trial to do so and contribute to helping our world-class scientists find a treatment that will save lives.’
Participants will be closely monitored for the first 28 days of the trial, with a health record notes review taking place for up to three months to understand the longer-term effects of the illness on their health.
Professor Fiona Watt, Executive Chair of the Medical Research Council, which funded the trial with the NIHR, concluded: ‘This trial is very important. It is focussed on older people and those with co-morbidities, who are much more likely to be hospitalised with Covid-19. We need more people to join the trial to see if we can identify a drug that helps prevent people reaching hospital and speeds up their recovery.’
PRINCIPLE is led from the Primary Care Clinical Trials Unit at the University of Oxford.
For details of participating GP surgeries, and a link to the online screening questionnaire here
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