Oxford researchers have launched a study to track the spread of COVID-19 in the population and develop a deeper understanding of the virus in general practice.
The University of Oxford’s Nuffield Department of Primary Care Health Sciences (NDPCHS) and the Royal College of General Practitioners (RCGP) have joined forces with clinical system supplier EMIS Health to urgently recruit as many GP practices as possible for COVID-19 research.
The PRINCIPLE trial, whose researchers are supported by the NIHR Oxford Biomedical Research Centre (BRC), is the first national COVID-19 trial outside of hospital.
The Oxford RCGP’s Research and Surveillance Centre (RSC) has written to nearly 4,000 GP practices in England using EMIS Health systems asking them to contribute patient data to help them develop a deeper understanding of the COVID-19 pandemic in general practice.
The data – shared under strict governance guidelines – will enable researchers to understand the spread of COVID-19, including tracking when it peaks and helping to inform government strategy around measures such as social distancing and lockdown.
General practices are also being asked to support public health surveillance by supplying samples from symptomatic patients and providing extra blood samples from asymptomatic patients having routine blood tests. Some practices are also being asked to take part in rapid clinical trials of selected medicines to reduce the duration and severity of the virus.
The first trial will need up to 3,000 patients, so as many practices as possible are needed to support the work.
Prof Richard Hobbs, Head of the NDPCHS and Oxford BRC Theme Lead for Multimorbidity, said: “This has been an extraordinary collaborative effort to compress many months of work into a few days. We are finalising the first national COVID-19 trial outside of hospital, led by Prof Chris Butler; significantly extending the only national surveillance of COVID-19 outside of hospitals; and considering efficient COVID-19 information feedback to practices.”
The programme will form a key part of the UK approach to clinical trials of selected medicines to reduce the duration and severity of the virus.
Professor Simon de Lusignan, Director of the Oxford RCGP RSC said: “We already have around 100 practices taking part in the national flu virology surveillance scheme every year in collaboration with Public Health England. We urgently need to increase this. Without the support of more practices we will struggle to recruit the numbers needed for clinical trials.’
Dr Shaun O’Hanlon, Chief Medical Officer at EMIS Group said, “Data is a powerful weapon in the fight against coronavirus. Daily insight from frontline GP practices will allow us to track closely this public health emergency as it develops and enable vitally important research into treatments and a vaccination.
“We are very grateful to the many EMIS Health practices who already share data for research; this is done via automated systems, so it requires minimal effort. Practices should be reassured that EMIS Health, Oxford University and the RCGP take their responsibilities around data governance seriously and all patient data will be protected using well established ethical, legal and clinical principles.
“While we know that this is an additional request at a time of unprecedented pressure, we hope they will come forward to support this important national initiative.”
The PRINCIPLE trial (Platform Randomised trial of INterventions against COVID-19 In older people) is looking torecruit eligible subjects to a series of candidate therapies, with the first trial therapy commencing very shortly. These participants will be people with a recent onset fever or persistent cough, aged 50 and over with major co-morbidities, or aged over 65 with or without comorbidities.
To support the research, the NDPCHS and RCGP have created anew national primary care digital platform(ORCHID), which provides a daily routine primary care electronic health record feed.
This will be ble to support any other future COVID-19-related studies, such asevaluation of rapid COVID-19 tests as they become available, or supporting other mitigation strategies in the community.
The NDPCHS’s Centre for Evidence Based Medicine has established the Oxford COVID-19 Evidence Service, led by Oxford BRC-supported Professor Carl Heneghan, and the department is also supporting the COVID-19 Scientific Steering Committee, led by the BRC’s Theme Lead for Partnerships of Health Wealth and Innovation, Prof Trish Greenhalgh.