This BGS Blog was written by the PRINCIPLE Trial Team in collaboration with Miles Witham, Professor of Trials for Older People at Newcastle University, and National Specialty Lead for the NIHR Ageing Clinical Research Network.
It is clear to all of us now that COVID-19 has a disproportionate impact on older people – as clinicians in primary and secondary care looking after people with COVID-19, we have seen the devastating effects of severe COVID-19 illness and its often prolonged aftermath. A big research drive continues to better understand COVID-19 illness, to improve diagnostics, and to find treatments for COVID. Whilst much of this work has centred on those admitted to hospital, the majority of older people affected by COVID-19 are in our communities, living at home or in care homes.
The PRINCIPLE trial aims to find treatments for older people with symptoms of COVID-19 in the community which can reduce the risk of hospitalization and death. The trial is run by the University of Oxford, endorsed by the Chief Medical Officer of England as a National Urgent Public Health Priority trial and is strongly supported by the NIHR Primary Care and Ageing Clinical Research Networks. In this blog, we introduce PRINCIPLE and explain how geriatricians and colleagues looking after older people can support care home residents and patients in the community to take part in this vital research.
PRINCIPLE is an adaptive platform trial, which allows the addition of new intervention arms as potential treatments become available. Initially we were testing hydroxychloroquine, but this arm has been paused, and we have now added a new arm to test azithromycin. To date, nearly 700 general practices have been opened to recruitment and over 500 participants have been randomised. We urgently need more of those who are still contracting the disease to be given the opportunity to participate in the trial – particularly older people living with frailty, multimorbidity and including those living in care homes.
Fortunately, this innovative study is now available to every eligible person throughout the UK, as patients can now also be recruited centrally. Geriatricians can help by identifying and signposting patients to the study as we outline in this flow diagram. The study eligibility criteria are broad – participants should have symptoms of COVID and be aged 50 or over with comorbidity, or 65 and over with or without comorbidity. Participants do need to be able to give informed consent however.
So if you are working in the community or with care homes, here are some of the people with suspected or confirmed COVID infection who you could help us recruit:
- Care home residents (if still able to give informed consent)
- Older people that you see in the community, for example as part of hospital at home or early intervention schemes
- Older people that you are asked to consult with remotely because of suspected or confirmed COVID-19
You can direct potential participants to self-screen via the website www.principletrial.org. People can also be screened by calling the study team on 0800 138 0880. Patients are generally very pleased to be offered the opportunity to participate in this critically important research and are keen to be able to provide information about their illness for the greater good.
Every patient included in the study will be a massive contribution to this flagship Trial, and will be one step closer to generating sorely needed evidence to find treatments for COVID-19 and underpin the best possible care we can give to our patients. All of us who care for older people can help to ensure that the results are relevant to as broad a range of our patients as possible by making sure we help to give groups such as care home residents the opportunity to take part, and not be left out of research as they too often are.
Many thanks for thinking about supporting this study to find treatments for COVID-19. Your help is much appreciated.
Yours sincerely,
The PRINCIPLE Trial Team