Covid-19 hotspot: Sunderland 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 Sunderland, 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. 

More than 1,000 people across the UK have signed-up to take part in the ongoing PRINCIPLE Trial of potential community-based treatments for COVID-19.

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. 

Dr Saira Malik, Executive GP at Sunderland Clinical Commissioning Group said: “It is vitally important that if we are able to take part in Covid-19 research that we do, and the PRINCIPLE study offers people in South Tyneside and Sunderland the opportunity to take part in Covid-19 research from the comfort and safety of their own home.”

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 

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