The vital ‘PRINCIPLE’ of research

Successfully tackling – and eventually eradicating - COVID-19 will depend on high-quality research to help us understand the virus. Across the globe, researchers have turned their efforts towards developing interventions to help ease its symptoms, treat those who contract it, and potentially vaccinate against it. The College’s Research and Surveillance Centre (RSC), based at the University of Oxford, has a proven-track record in virology surveillance and turned its attention to COVID at the start of the pandemic.

COVID-19 research is being prioritised by the UK Government and the RSC is involved in one of the country’s three national priority clinical trials on COVID: the Platform Randomised trial of INterventions against COVID-19 in older peoPLE (PRINCIPLE).

PLATFORM RANDOMISED TRIAL OF INTERVENTIONS AGAINST COVID-19 IN OLDER PEOPLE

PRINCIPLE, the first trial of COVID-19 treatments to take place in primary care is widely considered to have historic potential as it represents a significant step in tackling the virus. It is 'one of the largest' COVID trials in the world in terms of its infrastructure and enables researchers to swiftly and easily assess a variety of treatments that may ease COVID symptoms in vulnerable and older people at a community level.

General practice has played a crucial role in keeping people safe and well in the community, helping to ensure the NHS doesn’t become overwhelmed during the crisis, and this trial has the same aim – focussing on the most vulnerable patients, including those who are most likely to be admitted to hospital with COVID, to find a treatment that can be prescribed by community-based GPs and ultimately benefit patients with the virus.

RESEARCH AND SURVEILLANCE CENTRE

The trial aims to recruit more than 3000 patients and the RSC’s established and vast network of practices is playing a key part in this recruitment.

Dr Nicholas Thomas, RCGP Clinical Lead for Research

"The PRINCIPLE trial is one of the largest acute care treatment trials in the world“

The RSC provides the PRINCIPLE trial with COVID surveillance information, therefore aiding patient identification. The RSC also extracts and processes the study data as well as acting as a vehicle for the monitoring and following-up of participants throughout the course of the trial.

Following a nationwide call for participants, PRINCIPLE has just reached the landmark 1000th recruit and is open to all GP practices across the UK. Patients are recruited remotely, directly by the study team or via their GP surgeries. It is open to patients with COVID-like symptoms who are over 65 years of age or aged 50-65 with underlying health conditions.

TREATMENT EVALUATION

The trial started with the evaluation of the malaria drug Hydroxychloroquine as some evidence suggested it might help to prevent hospitalisation of patients with COVID-19. The drug became prominent at the height of the pandemic but PRINCIPLE is no longer evaluating its potential impact on COVID symptoms because new evidence suggests it may not be an effective treatment within primary care settings. The trial has since gone on to evaluate the antibiotics Azithromycin and Doxycycline. Unlike most traditional clinical trials where a single treatment is evaluated, the design of the PRINCIPLE trial allows for the evaluation of several potential treatments at the same time and presents an opportunity for more patients in the trial to get the most effective intervention possible.

PRINCIPLE is ground-breaking in its infrastructure. The platform allows for quick and easy testing throughout the country and the College looks forward to seeing the potential of more interventions as they are added to the platform.

Dr Nicholas Thomas, RCGP clinical lead for research, said: “Research as a discipline has robustly responded to the challenge of the pandemic, and the RSC’s unique infrastructure and UK-wide coverage has put it in a fantastic position to try to identify a treatment for the virus.

“The PRINCIPLE trial is one of the largest acute care treatment trials in the world and we should celebrate the 1000 recruit milestone. The research being carried out promises to play an integral role in increasing the profession’s understanding of COVID-19 and primary care has a key part to play in this. I would encourage all of our members to take part in PRINCIPLE and contribute to this vital work.” 