Yorkshire residents urged to take part in community Coronavirus trial

Following a significant rise in the number of cases across parts of Yorkshire, 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. 

Local health leaders and researchers are appealing for people with typical Covid-19 symptoms to take part in the community-based clinical trial called PRINCIPLE. 

The NIHR-supported 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 Mahendra G Patel (University of Bradford) Co-Investigator and National BAME Community and Pharmacy Research Lead for the PRINCIPLE Trial said: 

“The case numbers within the Yorkshire region are rising fast, as are hospital admissions and potentially more serious adversities too. It is crucially important  we reach out to all our communities and those most affected, such as the elderly and vulnerable with urgency. The region has also some of the largest Black and Asian Minority Ethnic communities in the country,  and it’s vital we use our resources and wider networks, including community and primary care pharmacy workforce, to help engage with these communities more effectively. 

“An important feature of engaging with the PRINCIPLE Trial is that it involves no face to face visits nor anyone having to leave their home with monitoring of symptoms for 28 days by the Trials Team at Oxford.”

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.” 

Chief Investigator for the trial, Professor Chris Butler, Professor of Primary Care in the Nuffield Department of Primary Care Health Sciences said: “The PRINCIPLE trial platform is enabling us to rapidly evaluate potential treatments for Covid-19 in older people who are most at risk of serious complications from the illness. With enough people recruited, 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 – a significant milestone in the course of this pandemic. 

“As soon as we find that any one of the drugs in our trial is making a critical difference to people’s health, we want it to be part of clinical practice as soon as it can be introduced.” 

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 121 GP practices across Yorkshire and Humber 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