A UK trial of drugs which could prevent people aged over 50 who are vulnerable to developing serious coronavirus symptoms is now recruiting participants from across the country.
Led by an Oxford University team, the Platform Randomised trial of Interventions against COVID-19 in older peoPLE (PRINCIPLE) trial is testing pre-existing drugs for older patients in the community who show signs of the disease.
It aims to slow or halt the progression of the COVID-19 and prevent the need for hospital admission.
PRINCIPLE is 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.
More than 500 GP practices across the country are already recruiting people aged 50 and over with underlying health conditions, or people aged over 65 regardless of underlying health conditions, into the trial.
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.
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.
Integration of the trial with the Royal College of General Practitioners (RCGP) Research and Surveillance Centre, a rapidly expanding network of over 1,100 GP practices, is enabling this extended follow-up to take place. As well as recruiting patients into the PRINCIPLE trial, GP practices in the network continuously monitor and report on the prevalence of infections and diseases in the community through swab testing, including COVID-19.
The PRINCIPLE trial platform has received £1.7 million from UK Research and Innovation (UKRI) and the Department of Health and Social Care through the National Institute for Health Research (NIHR).
It is part of a wider £24.6 million rapid research response investment by the UK Government to support looking at ways to tackle the coronavirus outbreak.
Click here for details of participating GP surgeries, and a link to the online screening questionnaire.