Patients from across the South West Peninsula (Cornwall, Devon and Somerset) are being enrolled into the firstclinical trial of potential COVID-19 treatments to take place in GP practices.
The nationally coordinated PRINCIPLE (Platform Randomised trial of INterventions against COVID-19 in older pePLE) trial, led by the University of Oxford, has seen the first participants recruited regionally and many more sites are opening to deliver the trial. There are currently thirteen General Practices in the region with the site open for recruitment and a further 61 that have expressed an interest to run it.
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.
Unlike many other clinical trials for COVID-19, which are mostly focussed on providing treatment to those who already have serious symptoms and are admitted to hospital, the PRINCIPLE trial looks to identify treatments that can be prescribed by community-based GPs to slow or halt the progression of the disease and prevent the need for hospitalisation.
Only those at most risk of complications from COVID-19 will be eligible to join the trial via participating GP surgeries, that’s people aged 50 to 64 with underlying health conditions, or people aged 65 and above.
Mr Will Moyle, Practice Manager at the Teign Estuary Medical Group in Teignmouth, enrolled the first patient participant in the region to the trial within 24 hours of it opening for recruitment. He said:
“We are very proud to have been the first practice in the South West to recruit and randomise a patient to the PRINCIPLE Trial. Within three hours of sending out the text messages we had our first patient consent via the study website. This has been one of the most straightforward studies the practice has run; and I would highly recommend all practices that have not already expressed an interest to sign up via their local Clinical Research Network (email@example.com)”
Research delivery staff at General Practices from across Cornwall, Devon and Somerset are working together to ensure the trial is set up and available for patients to participate in. Dr Lisa Gibbons and staff at Claremont Medical Practice in Exmouth have been using collaborative ways of working and innovative ways of communicating with their patients to make them aware of the trial, she said:
“We have been keeping all our staff involved in the process of delivering the study. The whole team are involved but a special mention must go to Kirsty Nichols our Research Administrator who worked so hard and manged to text our patients [with information about the trial] against the odds. The usual texting system has been overwhelmed with texts about Covid-19 but she found a way to get the texts sent quickly. There was great excitement in the team when the first call came through, from a patient asking to participate, just half an hour after the texts went out.”
“We are really keen to support research into Covid-19 and are delighted to be able to offer our patients this study.”
Delivery of the trial is coordinated by the National Institute for Health Research, Clinical Research Network, Dr Pauline McGlone, Chief Operating Officer, said: “We work with all the organisations across the South West to ensure that they are involved in supporting COVID-19 research. It is vital during this outbreak that our patients have the opportunity to participate in this vital research. There is a need to gather reliable evidence on the treatments that will work and this will be done through all our organisations and all parts of the country supporting research.”
In the first instance, the trial is evaluating a drug called hydroxychloroquine. This drug is well known and has been used for many years around the world for conditions such as malaria and certain types of arthritis. The drug is not currently used to treat coronavirus infection because it is not yet known whether it is an effective treatment. The trial aims to answer this question. The antibiotic azithromycin will soon be added to the trial.
Dr Kevin Douglas (Claremont Medical Practice): said: "This is a fantastic example of how powerful research in the NHS can be. Within weeks of the pandemic starting, we are testing drugs in real time to see if they work. This is a real testament to our patients of how prepared that are to participate so quickly".
PRINCIPLE aims to recruit over 3,000 people. This number will be increased if additional treatments are introduced and may also be adjusted in light of results that emerge during the course of the trial.