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Residents in Bristol called upon to sign up to national priority community-based COVID-19 trial

Residents in Bristol called upon to sign up to national priority community-based COVID-19 trial

With rising cases of COVID-19 in Bristol, researchers are appealing for people with typical COVID-19 symptoms, aged over 50 years with existing medical conditions, or over 65 years with or without existing medical conditions, to take part in PRINCIPLE, a national priority status clinical trial.

The trial, which is one of the UK Government’s national priority platform trials on COVID-19 treatments, can be joined online or by phone from home without the need for face-to-face visits.

Led by Oxford University, 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 illness, without the need for hospitalisation.

Delivered through primary care, the trial is supported by 61 GP practices across the West of England. So far, 86 people across the region have taken part in the trial, including 47 people from Bristol. Across the UK more than 1,200 people have signed-up. 

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 West of England.

Whiteladies Medical Group is one of the practices in Bristol taking part in the study. Dr Stephen Granier from the practice said: 

“This study is essential to tell us what treatments work, so we can help more people to recover as quickly as possible.

“All of our wonderful support staff and clinicians are involved in recruiting. This involves contacting people who may be eligible, and monitoring all contacts with 111 and emergency services, or recruiting people when they contact the surgery with symptoms. We want to offer the opportunity to participate in the PRINCIPLE study to all patients at risk who develop flu like illness, fever or a cough.

“The PRINCIPLE trial is an example of the high quality research carried out in the UK. It is a privilege to be contributing to such an important trial at such a time of need during the COVID-19 pandemic.”

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.

Participants can sign up via the PRINCIPLE website: www.principletrial.org/participants. Participants without internet access can contact the trial team directly by calling 0800 138 0880.