Case study: Testing treatments for COVID-19 through GP surgeries - PRINCIPLE
Treating COVID-19 in the community
The PRINCIPLE trial is the first to test potential treatments for COVID-19 through GP surgeries. Funded by NIHR and UK Research and Innovation, the trial is one of the UK Government’s national priority platform trials into COVID-19, which are being delivered across the NHS with support from NIHR’s Clinical Research Network.
Led by a team at the University of Oxford, PRINCIPLE is testing drugs that could prevent the need for hospitalisation in people over 50 with COVID-19. The study is looking at patients who are especially vulnerable to COVID-19 because of pre-existing health conditions such as heart disease or a weakened immune system.
Could existing treatments help tackle COVID-19?
More than 800 GP practices across the country are recruiting participants who have COVID-19 symptoms and are aged 50 and over with underlying health conditions. People aged over 65 with symptoms can also take part, even if they don’t have any underlying conditions.
In its first phase, the PRINCIPLE trial is evaluating two drugs that are already in use for other health conditions, to see if they could help to treat COVID-19.
Initially the study was investigating whether a seven-day course of hydroxychloroquine could reduce the severity of COVID-19 symptoms. However, recently further evidence has emerged from other research studies showing that the drug isn’t beneficial for COVID-19, so this drug is no longer part of the PRINCIPLE trial. The antibiotics doxycycline and azithromycin are also being tested as part of the trial - these are both already widely prescribed and are thought to have antiviral and anti-inflammatory properties.
The trial is screening participants online, as well as recruiting through GP surgeries. This means that regardless of which GP surgery they are registered with, older people with coronavirus symptoms can pre-screen for the trial at home via an online questionnaire to see whether they can be included. Over 800 participants have already joined the trial.
“The Government is working with researchers to find proven, effective treatments for COVID-19. This PRINCIPLE trial is a vital part of this research effort and it’s being scaled up by GP surgeries across the country. I would urge anyone who is contacted to take part in this trial to do so and contribute to helping our world class scientists find a treatment that will save lives.”
Chief Medical Officer Professor Chris Whitty
Helping patients recover sooner
Angela Houghton-Cole took part in PRINCIPLE - she’s living with Type 2 diabetes and developed symptoms of COVID-19 on 30 April 2020.
“I didn’t have a temperature, but I just couldn’t stop coughing and my chest felt really tight,” said the 52 year-old, who lives in Congleton, East Cheshire, with husband Martin.
“I was sent home from work and isolated myself. The coughing was so severe that I ached for a number of days afterwards and I also had a terrible headache.”
Mrs Houghton-Cole called her GP at Readesmoor Medical Centre in Congleton. In addition to receiving medical advice, she was told she also fitted the PRINCIPLE trial criteria due to her pre-existing health conditions and COVID-19 symptoms.
Her participation involved taking a tablet twice a day for seven days while continuing to self-isolate. It also involved completing a 28-day online diary of how she was feeling. Her COVID-19 swab was later shown to be negative.
“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.”
Helping support NHS hospitals
Professor Chris Butler, Professor of Primary Care in the Nuffield Department of Primary Care Health Sciences, is Chief Investigator for the trial and explained its importance in helping patients and taking pressure off NHS hospitals.
“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.”