Greater Manchester and East Cheshire patients encouraged to take part in urgent COVID-19 research trial taking place in GP practices

Thousands of patients across Greater Manchester and East Cheshire now have the opportunity to take part in the first clinical trial of potential COVID-19 treatments to take place in GP practices. 

The National Institute for Health Research (NIHR) in Greater Manchester is supporting local family doctor practices to ensure they can start enrolling patients on to the study, called PRINCIPLE, as soon as possible.

The Platform Randomised trial of Interventions against COVID-19 in Older People (PRINCIPLE) will enable researchers to rapidly evaluate different treatments that could stem the progression of COVID-19 symptoms in older people and help ease the burden on hospitals.

More than 15 NHS practices in Greater Manchester and East Cheshire are already enrolling patients and the list of participating sites is growing all the time. Staff at GP practices are working hard to fast-track the study set-up process in express time to support the fight against COVID-19.   

The NIHR Clinical Research Network (CRN) for Greater Manchester is encouraging all eligible patients to consider taking part in this vital study. 

In addition, GP practices interested in carrying-out COVID-19 research are encouraged to get in touch with NIHR CRN Greater Manchester, in line with Chief Medical Officer Professor Chris Witty’s message that every effort should be made across the NHS to recruit eligible patients on to COVID-19 studies. 

PRINCIPLE is one of three key urgent public health research studies prioritised by the government Department of Health and Social Care. 

It is focusing on people with symptoms which suggest they may have COVID-19 and are aged over 65, as well as people with existing health conditions aged 50 to 64. [* see notes for editors for full criteria] 

The study aims to find out whether selected treatments prevent the disease’s progression in these patients, and whether these patients could recover sooner and avoid the need for hospital admission. This could reduce their personal risk of complications and relieve the pressure on NHS services and resources.

Dr Sheila McCorkindale, Specialty Lead for Primary Care at NIHR CRN Greater Manchester, said: “Research is a key part of the government’s strategy to stop COVID-19 and it is vitally important that studies are carried out with patients in all types of clinical settings – including those patients being seen by doctors in General Practices and Out-Of-Hours services.

“Staff at many of our local Primary Care centres have been doing an excellent job in fast-tracking the set-up of this urgent priority study and we would like to thank them for their efforts at this difficult time. The more sites involved with the study, the more patients can take part, potentially benefit from the treatments, and the more questions we can answer about this new disease.”

There are currently no known treatments which have been proven to be effective for COVID-19. The PRINCIPLE study will test suitable, potential treatments for the virus as soon as they become available.

In the first instance, the study will evaluate a drug called hydroxychloroquine. This is a well-known drug that has been used for many years around the world for conditions such as malaria and arthritis, but is not currently used to treat this kind of infection.

Participating practices in Greater Manchester and East Cheshire so far are (numerous more to be added): Tower Family Healthcare, Bury; The Gill Medical Centre, Walkden; Springfield Medical Centre, Eccles; Manchester Medical, Moss Side; Bodey Medical Centre, Fallowfield; Barlow Medical Centre, Didsbury; West Timperley Medical Centre, West Timperley; Ashville Surgery, Whalley Range; Middlewood Partnership, East Cheshire; Readesmoor Medical Centre, Congleton; all six surgeries based in Waters Green Medical Centre, Macclesfield (High Street Surgery, Broken Cross Surgery, Cumberland House Practice, Park Green Surgery, South Park Surgery, Park Lane Surgery).    

Practices in East Cheshire are also working closely with the Out-Of-Hours service, operated by East Cheshire NHS Trust, to enrol patients who are accessing NHS healthcare outside of regular GP working hours.  

Dr Pete Wilson from the Middlewood Partnership based in Bollington, Disley and Poynton, said: “As a partnership with a strong reputation for research, for a number of years we have been proud to offer our patients the opportunity to take part in a whole range of studies looking at treatments for numerous conditions. 

“So when faced with the national emergency that COVID-19 has presented to us all, we were determined to get the PRINCIPLE study set-up extra fast - a task that’s taken a lot of hard work alongside our continued clinical care, but one which our team has carried out superbly. Every patient who takes part will be contributing towards the understanding of how COVID-19 can be treated and how the symptoms progress.”

Patient participation in the PRINCIPLE study

Patients who experience a continuous cough and/or a high temperature and have had it for less than 15 days are encouraged to seek more information about taking part in the study. Go to https://www.phctrials.ox.ac.uk/hidden-pages/principle-trial/how-to-join or call the study team on 0800 138 0880. Full eligibility details are available at the above link.

Practices interested in carrying-out COVID-19 research

General practices based in Greater Manchester or East Cheshire and interested in carrying-out COVID-19 research are asked to contact NIHR Clinical Research Network Greater Manchester on researchsupport.crngm@nihr.ac.uk