East Cheshire residents experiencing Covid-19 symptoms are invited to take part in a clinical trial to explore a possible treatment for the disease that can be taken at home.
The PRINCIPLE trial, led by Oxford University and supported by the National Institute for Health Research (NIHR) is looking to explore possible drugs to reduce recovery time, improve symptoms and prevent hospital admissions.
Since launching in March 2020, PRINCIPLE has recruited more than 4,400 participants from across the UK – including more than 180 from Greater Manchester and East Cheshire. As part of the trial, several commonly-used medicines with well-known safety profiles are being evaluated and compared with usual NHS care.
Previously, only those with Covid-19 aged 50 or over and at most risk of complications from the illness were eligible to join the PRINCIPLE trial. Now, the trial is evaluating the effectiveness of treatment with gout drug colchicine, and has expanded to include adults of any age with Covid-19 symptoms.
For the colchicine arm, the trial now includes participants either aged 18-64 with shortness of breath from the illness or certain underlying health conditions that put them at risk of severe illness, or those aged over 65. Participants are only eligible to join the trial during the first 14 days of Covid-19 illness.
Colchicine is an inexpensive anti-inflammatory drug widely used in the UK for many years as a treatment for acute gout. In Canada’s ColCorona trial, the drug has recently shown promise in reducing hospital admissions in patients with Covid-19, yet little is known about its effectiveness in reducing recovery time or the burden of the illness.
With the UK’s vaccine programme continuing at pace in vulnerable adults, and the remaining urgent need for evidence-based treatments that help people recover at home, expanding parts of the trial to people aged under 50 will provide new insights into whether treatments can help those at greater risk of severe Covid-19 illness.
A vast network of community health and care organisations across the UK’s four nations now support patient recruitment into PRINCIPLE – including more than 110 GP practices in Greater Manchester and East Cheshire.
NHS Researchers in Greater Manchester are today renewing their call for eligible adults with early Covid-19 symptoms to consider joining the trial.
Dr Sheila McCorkindale, Specialty Lead for Primary Care at NIHR Clinical Research Network Greater Manchester, said:
Clinical research is one of the NHS’ greatest assets in the fight against Covid-19 and has already helped identify safe and effective vaccines and medications that are helping reduce the risk of death in the sickest patients hospitalised with the virus.
“However, it’s also crucial that we determine which treatments can help people experiencing milder Covid-19 symptoms, so they can get better at home and not need hospital treatment. The PRINCIPLE trial is the way we can do this, and I urge anyone who develops symptoms to take a look at the website or ask their GP or other healthcare provider about this study.
“The criteria for taking part is now much wider – meaning any adult with symptoms could potentially be part of this urgent research.”
Toni Symons, 56, of Macclesfield, took part in the PRINCIPLE trial after developing typical COVID-19 symptoms. She had a high temperature, a persistent cough and felt very achy. Her participation involved taking a commonly-used antibiotic twice a day for three days and completing a 28-day online diary of how she was feeling. Mrs Symons, a mother of three and grandmother of five said:
With COVID being such a big problem, it’s more important than ever that we find out as much as we can so we can move forward. The more people who can get involved in studies like this, the more researchers can learn and identify treatments that work.”
About the PRINCIPLE trial
Following a screening questionnaire to confirm eligibility, participants will be randomly assigned a study drug or the usual standard-of-care NHS treatment. Those assigned to colchicine will receive a 14-day course of 500 micrograms (mcg) colchicine tablets, will be followed-up for 28 days and will be compared with participants who have been assigned to receive only the usual standard-of-care.
Those excluded from the colchicine study include women who are pregnant or breastfeeding, people taking certain medications, or those with inflammatory bowel disease.
People with coronavirus symptoms, or a positive test result, can join the trial easily online, over the telephone or via their GP practice from anywhere in the UK, without needing face-to-face visits.
The decision to widen the trial’s inclusion criteria and include colchicine was made by the University of Oxford researchers and the trial steering committee in conjunction with Chief Medical Officer for England, following a recommendation by the UK COVID-19 Therapeutics Advisory Panel.
The PRINCIPLE trial has so far determined that the antibiotics azithromycin and doxycycline are not effective treatments during the early stages of Covid-19. The trial continues to investigate budesonide, an inhaled corticosteroid, in people aged over 50.
PRINCIPLE is funded by a grant to the University of Oxford from UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research as part of the UK Government’s rapid research response fund.
To find out more about how to join the study, visit the trial website or call 0800 138 0880.
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