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Members of the public can sign up to community-based COVID-19 treatment trial

Members of the public can sign up to community-based COVID-19 treatment trial

More than 1000 people across the UK have signed-up to take part in the ongoing PRINCIPLE Trial of potential community-based treatments for COVID-19, including 57 residents from Kent, Surrey and Sussex.

Delivered through primary care, PRINCIPLE is evaluating whether treatment early on in the community, rather than hospital settings, can help people aged over 50 recover quickly from COVID-19, without the need for hospitalisation.

Led by Oxford University, the trial is supported by 35 GP practices across the region and can be joined online at www.principletrial.org, or by phone from home without the need for face-to-face visits. It is one of the UK Government’s national priority platform trials on COVID-19 treatments.

PRINCIPLE is currently evaluating azithromycin and doxycycline, which are two commonly prescribed antibiotics. These drugs are thought to have anti-viral and anti-inflammatory properties against coronavirus, and also treat bacterial infections like pneumonia, which is a common reason for deterioration in people with COVID-19, and excessive inflammation is a cause of complications.

The trial is supported across the region by the National Institute for Health Research Clinical Research Network Kent, Surrey and Sussex.

Dr Paul Deffley, National Institute for Health Research Clinical Research Network Kent, Surrey and Sussex specialty lead for Primary Care and GP at Trinity Medical Centre, Hove said: “We know that the vast majority of people who test positive for COVID-19 don't require hospital treatment, so the biggest burden of the illness is in our community.

“Research being delivered in community settings is essential if we are to understand what are the best treatment options for patients with COVID-19. This is to ensure they have a speedy recovery and are less likely to suffer the complications of what is proving to be a very testing illness for our communities and frail populations. It is critical that people volunteer to participate in the trial.”

Local NHS researchers and GPs involved in the trial are urging people experiencing symptoms likely to be caused by a Covid-19 infection, for no more than 15 days, to take part. People may also be eligible to join the study if they have had a positive test for Covid-19 infection which was taken less than 15 days ago, and are unwell with any symptoms. People who are already well on the way to recovery or who are otherwise healthy are not eligible to participate in the trial.

Co-lead Investigator Professor Chris Butler from Oxford University’s Nuffield Department of Primary Care Health Sciences, said: “Until a really effective vaccine is developed and rolled out, finding effective treatments that can be given to people at home who show symptoms of COVID-19 will help people to recover more quickly, will prevent the risk of serious illness and hospitalisation, and ultimately will contribute to lessening the burden of this pandemic on society.

“We’ve designed this community trial of COVID-19 treatments to make it as accessible as possible for people so they can join from the comfort of their own home, with study medication posted to them and follow-up via an online diary or with our team of nurses over the phone.

“Now that we’re seeing more cases of COVID-19 in the community, we’re relying on the continued support of health and care professionals to rapidly introduce eligible patients to the trial, as we urgently need many more people to join to help us find which drugs work. This is so people from all backgrounds who are at higher risk of complications from COVID-19 can get evidence-based treatments as quickly as possible.”

The PRINCIPLE Trial is open to people with coronavirus symptoms who are aged over 50 with an underlying health condition or aged over 65 with or without an underlying health condition. It is funded from UK Research and Innovation and the Department of Health and Social Care through the National Institute of Health Research as part of the Government’s rapid research response fund.

Volunteers from British Asian communities, who are often underrepresented in this type of research are particularly welcome to take part as they can be at higher risk of developing more serious COVID-19 illness.

To widen community access to the PRINCIPLE trial, Professor Mahendra G Patel has joined the trial as Co-Investigator and will act as the trial’s National Black, Asian and minority ethnic Community and Pharmacy Research Lead.

An Honorary Visiting Professor at the University of Bradford’s Faculty of Life Sciences and Visiting Professor at the School of Life Sciences the University of Sussex, Professor Patel is a senior academic and pharmacist of national and international profile and brings decades of experience and knowledge around health inequalities and working with Black, Asian, minority ethnic and disadvantaged groups.

Professor Patel said: “I am delighted and honoured to be joining the PRINCIPLE Trial for this very important work in the crusade against coronavirus, and I look forward to promoting and supporting the wider recruitment of people to the trial through my national pharmacy and community networks. There has to be a more concerted and tailored effort to reach out to Black, Asian and minority ethnic communities more effectively in health research, particularly in the case of COVID-19 where we are seeing members of these communities unfortunately experiencing a greater risk of contracting the virus with higher adverse effects and even deaths.

“South Asian communities have a different outlook to engaging with health research and studies, and this may the case be with Black and other minority ethnic groups as well. How you reach out to the different communities is vital to ensure proper understanding and confidence is attained owing to people’s different cultural and religious beliefs and attitudes. Of course, the more people volunteering to take part in these studies and trials, the greater the likelihood for an effective and safe means of tackling the virus is established.”