West Midlands Covid-19 hotspots: residents urged to take part in community coronavirus trial

Following a significant rise in the number of cases (and the introduction of local coronavirus restrictions) across Birmingham, Solihull, Sandwell and Wolverhampton, residents are being urged to sign up and take part in a national priority Covid-19 clinical trial from the comfort of their own homes.

The NIHR-supported PRINCIPLE study, led by the University of Oxford, is evaluating whether certain commonly used medicines may prevent patients in the community 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.

Researchers need people aged 50-64 years with pre-existing medical conditions, or otherwise healthy people 65 years and over.

The study is looking at patients who are especially vulnerable to Covid-19 because of age, or pre-existing health conditions such as heart disease or a weakened immune system. Evidence shows that people aged 50 years and over are at higher risk of developing more severe illness and complications.

As a community-based primary care Covid-19 trial, no face to face visits are required of those taking part - just telephone or internet access - while participant packs will be couriered to patient’s homes. In addition to the clinical study team being at the end of the phone, participant’s GP practices will also be notified of the study and can discuss it with anyone taking part.

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.

Currently, there are no effective treatments available that have been shown through clinical trials to reduce Covid-19 disease burden in the community. The PRINCIPLE trial could be a key part of achieving that. It aims to produce evidence which will establish whether existing drugs can benefit Covid-19 patients in the community, before their conditions worsen where admission to hospital is required.

Professor Nick Lemoine, Medical Director of the NIHR Clinical Research Network said: “We have seen a significant increase of local outbreaks across the country over recent weeks - giving rise to the potential for serious illness, Covid-related deaths and NHS hospitals reaching capacity. We are urging residents with a positive Covid test who are in an at risk group - older people and those with multiple long-term conditions - to sign up for this important study. Now more than ever, taking part could reduce your risk of being hospitalised and serious ill health, help identify the best ways to treat this disease, and reduce pressure on our NHS over the long winter months ahead.”

Dr David Shukla, Primary Care Clinical Research Lead for the Clinical Research Network West Midlands (CRN WM) said: "If we can recruit enough people, this trial will give us the vital information we need to understand whether existing drugs can help people recover sooner and at home, without needing to be admitted to hospital."

The unique study design means that new treatments can be investigated or halted quickly, as and when possible treatments come to light or evidence has been established. Currently the medicines being investigated through the trial are:

- Usual care + azithromycin (a commonly used antibiotic) or,
- Usual care + doxycycline (a commonly used antibiotic)
- Participants may also be assigned to receive usual care only

Researchers from the study are working with GP surgeries, care homes, NHS111 and ambulance services right across the country to help their patients take part. Currently 96 GP practices across the West Midlands are recruiting patients on to the trial.

Local residents who meet the criteria can still self-enrol in the study, even if your GP practice is not directly recruiting - visit the PRINCIPLE website for more information. You can also telephone the study team on 0800 138 0880 to ask questions and for further information.

Further details about the study can be found at: www.principletrial.org

ENDS

For further information contact Claire Hall, Communications Lead on 07775 800227.

Notes to editors:

About PRINCIPLE

The PRINCIPLE trial is funded from UK Research and Innovation (UKRI) 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. Delivery of the trial is being supported by the NIHR’s Clinical Research Network right across the country.

About the NIHR

The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR:
● Funds, supports and delivers high quality research that benefits the NHS, public health and social care
● Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
● Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
● Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
● Partners with other public funders, charities and industry to maximise the value of research to patients and the economy

The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK government.

About UK Research & Innovation:

UKRI works in partnership with universities, research organisations, businesses, charities, and the government to create the best possible environment for research and innovation to flourish. It aims to maximise the contribution of each of their component parts, working individually and collectively. They work with many partners to benefit everyone through knowledge, talent and ideas.
Operating across the whole of the UK with a combined budget of more than £8 billion, UKRI brings together the seven Research Councils, Innovate UK and Research England.

About Nuffield Department of Primary Care Health Sciences

Oxford University’s Medical Sciences Division is one of the largest biomedical research centres in Europe, with over 2,500 people involved in research and more than 2,800 students.

The University is rated the best in the world for medicine and life sciences, and it is home to the UK’s top-ranked medical school. It has one of the largest clinical trial portfolios in the UK and great expertise in taking discoveries from the lab into the clinic. Partnerships with the local NHS Trusts enable patients to benefit from close links between medical research and healthcare delivery.
Within the division, the Nuffield Department of Primary Care Health Sciences undertakes internationally acclaimed teaching and research that improves the primary care that GP practices deliver, and is ranked top in the UK. The department’s research covers a broad range of primary care issues including cardiovascular and metabolic disease, health behaviours, infectious disease and child health, patient experience, research methods and evidence-based medicine. www.phc.ox.ac.uk

The Primary Care Clinical Trials Unit is an integral part of the University of Oxford's Nuffield Department of Primary Care Health Sciences. Our research themes are aligned with the departmental priorities on infectious diseases, cardiovascular and metabolic disease, behavioural medicine and other topics of major national and international importance. In 2016 the unit recruited almost 6000 participants from around 600 sites in over 20 countries.

The unit is part of the Primary Care and Vaccine Collaborative Clinical Trials Unit (PCVC-CTU) consortium in recognition of its ability to coordinate high quality, academically-led, multi-centred clinical trials. We work closely with NHS Trusts across England and Wales and the UK Clinical Research Network.