Greater Manchester residents urged to take part in community coronavirus trial

Following a significant rise in the number of cases across Greater Manchester, 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 from the National Institute for Health Research are appealing for people with typical Covid-19 symptoms to take part in the community-based clinical trial called PRINCIPLE. Over 60 people have taken part in Greater Manchester and East Cheshire so far. 

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 Sheila McCorkindale, Specialty Lead for Primary Care at NIHR CRN Greater Manchester, said: “The recent increase in the number of COVID-19 infections in Greater Manchester highlights the ongoing need for COVID-19 research. We can all help fight the virus by supporting clinical research and many thanks to everyone who's already contributed. 

“The PRINCIPLE clinical trial aims to find treatments that can help older people with COVID-19 symptoms get better quickly and stop them needing to go to hospital. I’d encourage everyone to take a look at the PRINCIPLE website or ask their GP or other healthcare provider about this study should they develop symptoms.”

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 over 50 GP practices across Greater Manchester and East Cheshire 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