Banburyshire GP surgeries join Covid-19 trial to help higher-risk patients avoid worst effects of virus

The trial involves using low-risk treatments that are already in use to see if they can help people at higher risk of complications from the virus to get better quicker, reducing the need for hospitalisation.

It involves 500 surgeries who are recruiting people aged 50 - 64 (with a pre-existing illness) or those aged over 65 years. Older people who have had symptoms of coronavirus for 15 days or less can also screen for the trial online.

Led by an Oxford University team, the trial is called PRINCIPLE (Platform Randomised trial of Interventions against COVID-19 in older peoPLE) and it is the first trial of COVID-19 treatments to take place in primary care. It is also one of the UK Government’s four national priority platform trials on the disease.

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.

PRINCIPLE 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.

In the first phase, the trial is evaluating whether a seven-day course of hydroxychloroquine, a well-known drug used for acute malaria and certain types of arthritis, can reduce the severity of symptoms in vulnerable groups and help avoid hospital admission. The antibiotic azithromycin will soon be added to the trial.

The trial’s Chief Investigator, Professor Chris Butler, Professor of Primary Care in the Nuffield Department of Primary Care Health Sciences, 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."

Chief Medical Officer, Professor Chris Whitty said: "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.

Funding to the tune of £1.7m is part of a £24.6m rapid research response investment by the Government to support looking at ways to tackle the coronavirus outbreak.

Professor Fiona Watt, Executive Chair of the Medical Research Council, said: "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."

For details of participating GP surgeries, and a link to the online screening questionnaire, see here.

PRINCIPLE is led from the Primary Care Clinical Trials Unit at the University of Oxford.