Delivered through primary care, PRINCIPLE is evaluating whether treatment early on in the community can help people aged over 50 recover quickly from COVID-19 illness, without the need for hospitalisation.
Having launched across a network of 100 GP practices in April 2020, the trial has been scaled up to include over 900 GP practices. The trial has quickly innovated trial design, given the constraints of the pandemic, and is now also taking the research directly into patients’ homes so that anyone in the UK who is eligible can sign-up online from home or over the phone. This is regardless of which GP practice they are registered with, and without the need for face-to-face visits.
It is one of the UK Government’s national priority platform trials on COVID-19 treatments, and is endorsed by all four UK Chief Medical Officers.
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.
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 easy as possible for people so they can join from the comfort of their own home, with study medication couriered to them and follow-up via an online diary or with our team of nurses over the phone. For clinicians it’s a very ‘low-burden’ trial, there are no lengthy, paper forms.
“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 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 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.
Find out how to join the trial online here: www.principletrial.org