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Participants being sought to take part in national COVID-19 trial

Participants being sought to take part in national COVID-19 trial

12th October 2020

PRINCIPLE is a nationwide clinical trial to find COVID-19 treatments for the over 50s that can be taken at home

Led by Oxford University, the Platform Randomised trial of Interventions against COVID-19 in older peoPLE (PRINCIPLE) trial is testing pre-existing drugs for older patients in the community who show signs of the disease.

It aims to slow or halt the progression of the COVID-19 and prevent the need for hospital admission recognising those aged 50 years and over are at higher risk of developing more severe illness and complications from COVID-19.

Currently, there are no effective treatments available that have been shown through clinical trials to reduce disease burden in the community. PRINCIPLE is evaluating whether certain commonly used medicines may prevent patients with COVID-19 from becoming more unwell and needing hospital care. Several medicines with well-known safety profiles are being evaluated and compared with usual care.

The study design – a pragmatic, platform, randomised controlled trial – means that new treatments can be investigated or halted quickly, as and when possible treatments come to light or existing ones are shown to be ineffective.

Researchers are appealing for people experiencing symptoms that are likely to be caused by a COVID-19 infection, for fewer than 15 days, to join the trial – targeting those aged 50-64 years with existing medical conditions, or 65 years and over with or without existing medical conditions. People who are already well on the way to recovery or who are otherwise healthy are not eligible to participate in the PRINCIPLE Trial.

Researchers are recruiting participants through the trial website in Scotland.

The trial is funded from UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research (NIHR), as part of the UK Government’s rapid research response fund. The trial team are working with COVID hubs and NHS Scotland to recruit patients across Scottish Health Boards, as well as the NHS and partners in England, Wales and Northern Ireland.

Dr Ellen Drost, Network Manager for NRS Primary Care commented: “This study is important, as it may provide us with effective treatments for COVID-19 that can be administered within the community – reducing the number of people becoming unwell and consequently needing hospital treatment. As a community-based trial, it also helps ease pressure on the NHS at this time. We encourage anyone who meets the criteria to sign up via the study website.”

Professor Fiona Watt, Executive Chair of the Medical Research Council said: “This trial is very important. It is focussed on older people and those with co-morbidities, who are much more likely to be hospitalised with COVID-19. We need more people to join the trial to see if we can identify a drug that helps prevent people reaching hospital and speeds up their recovery.”

Dr Emma Ogburn, Director of Operations at Oxford University’s Nuffield Department of Primary Care Health Sciences Clinical Trials Unit, said: “It's really rewarding and exciting to be part of a trial where we are asking the general public to help find potential COVID-19 treatments. No face to face visits are needed, just internet access and participant packs will be couriered to you at home.

Prof Mahendra G Patel, National BAME and Community Pharmacy Research Lead for PRINCIPLE Trial said: “I'm really delighted to bring the important and valuable role of pharmacy to PRINCIPLE.

Pharmacists are often the first port of call for many within the community, especially when it comes to providing information regarding people’s health and signposting them to the right areas as appropriate. Community pharmacies though their workforce have a good local knowledge and intelligence of the communities they serve, such as the elderly, those in care homes, Black and Asian Minority Ethnic (BAME) communities, and those living in highly deprived areas — known to be at greatest risk of contracting the virus

This is certainly a huge opportunity for pharmacy in helping to reach out to people from all backgrounds and to help more volunteers take part in this flagship and very important trial."

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