NHS researchers seek participants for COVID-19 drugs trial taking place across Greater Manchester GP practices and communities
Greater Manchester and East Cheshire citizens experiencing COVID-19 symptoms have the opportunity to take part in a clinical trial of potential treatments that can be taken at home.
The Platform Randomised trial of Interventions against COVID-19 in older people (PRINCIPLE) trial is testing pre-existing drugs with older patients in the community who show signs of the disease.
It aims to slow or halt the progression of COVID-19 and prevent the need for hospital admission.
The trial has been running in Greater Manchester since April. However, with the infection rate in the region showing a significant spike in late July and into August, the National Institute for Health Research (NIHR) in Greater Manchester is now especially keen to get more people recruited on to the trial as part of the effort to identify medicines that help people with COVID-19 symptoms get better quickly.
PRINCIPLE is the first trial of COVID-19 treatments to take place in primary care, and one of the UK government’s national priority platform trials on the disease.
Fifty GP practices across Greater Manchester and East Cheshire are recruiting people on to the trial. Participants must be aged 50 and over with underlying health conditions, or people aged over 65 regardless of underlying health conditions.
In addition to this, the trial is also offering participants the opportunity to sign-up online. This means that irrespective of which GP surgery they are registered with, older people with coronavirus symptoms can now pre-screen for the trial at home via an online questionnaire to see whether they can be included.
PRINCIPLE is trialling a number of low-risk treatments recommended by an expert panel advising the Chief Medical Officer for England. The effectiveness of these treatments will be compared to the current best available care. In the current phase of the trial, researchers are evaluating the commonly-used antibiotics azithromycin and doxycycline.
Angela Houghton-Cole took part in PRINCIPLE after she developed COVID-19 symptoms in April. The 52-year-old, who lives in Congleton, East Cheshire, said: “My GP sent me all the information and I was able to talk it over with my husband and mum before making my decision. Ultimately, I felt that if I could contribute towards research that will help us better understand this awful virus and possibly help other people in the future, then it was something I wanted to be part of.” [Read Angela’s full story here].
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.”
Fifteen of the NHS GP practices run by SSP Health across Greater Manchester are delivering the PRINCIPLE trial. Dr Skikha Pitalia, SSP Health director, said: “We are really pleased to be part of this trial, which we hope can find further effective treatments for people with COVID-19 and reduce the burden on the NHS.
“The success of the steroid dexamethasone in the RECOVERY trial for COVID-19 shows that breakthroughs can happen quickly and that patients who come forward to help in medical research play a vital role in finding new treatments that can save many lives.
“We are urging our patients to help in this new trial, if they fit the criteria and feel able to. They could play a huge part in our battle against this disease.”
The trial’s Chief Investigator, Professor Chris Butler, Professor of Primary Care in the Nuffield Department of Primary Care Health Sciences at Oxford Univerisity, 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.”
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 consider taking part in the study. Go to https://www.principletrial.org/participants/how-to-join-the-trial or call the study team on 0800 138 0880. Full eligibility details are available at the above link.