PRINCIPLE Covid-19 treatments trial in the North East and North Cumbria widens to under 50s

• PRINCIPLE is the UK’s largest national priority platform trial evaluating Covid-19 treatments that can be taken at home to speed-up recovery and prevent hospital admission.  
• Colchicine, an inexpensive anti-inflammatory commonly used to treat gout, is added to the trial and is being evaluated in participants from today. It is the fifth medication to be investigated in PRINCIPLE.
• For colchicine, the trial widens to include anyone with confirmed or possible Covid-19 who is aged 18-64 with shortness of breath from the illness or certain underlying health conditions, or those aged over 65.
• The trial can be joined online, over the telephone or via a GP practice.

A NIHR-supported study evaluating potential COVID-19 treatments that can be taken at home will now expand for the first time to include adults of any age. 

The Platform Randomised trial of Interventions against Covid-19 In older peoPLE (PRINCIPLE) trial is investigating treatments for early-stage COVID-19 that can reduce overall recovery time and the burden of symptoms, and prevent the need for hospital admission. The study has been funded by NIHR and UK Research and Innovation as part of the UK Government’s rapid research response to the coronavirus pandemic.

By expanding parts of the trial to include people aged under 50, the study, led by an Oxford University team, will provide new insights into whether treatments can help those at greater risk of severe COVID-19 illness.

The trial will now include 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, and those aged over 65. Previously, only people with COVID-19 aged 50 or over and at most risk of complications from the illness were eligible to join the PRINCIPLE trial.

Researchers will also evaluate the gout drug colchicine, an inexpensive anti-inflammatory commonly used to treat gout. It is the fifth medication to be investigated in PRINCIPLE.

PRINCIPLE 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.

PRINCIPLE trial co-lead, Professor Chris Butler, a general practitioner and Professor of Primary Care at the University Oxford’s Nuffield Department of Primary Care Health Sciences, said:

“We are asking for eligible volunteers aged over 18 from all across the country to join the PRINCIPLE trial when they first experience Covid-19 symptoms, and help in the search for potential treatments. With Covid-19 still circulating in the community, and little known about the effect of new viral variants on younger adults, it is vital that we seize this window of opportunity to generate high-quality evidence to determine which treatments work, and which don’t.

“Even with successful vaccines and other preventable measures in place, the availability of treatments with a solid evidence-base has a critical role to play in ending this pandemic, yet there are still very few options for treating Covid-19 before it becomes a severe illness.”

Professor Caroline Wroe, Clinical Director at NIHR Clinical Research Network North East and North Cumbria said: 

“The PRINCIPLE trial will help us answer a really important research question about how best to treat COVID in a community setting, now for younger as well as older people. 

“I encourage anyone across the region to sign up and take part if they feel able to, we still need volunteers to help us beat Covid-19.”

Minister for Innovation Lord Bethell said: 

“The UK continues to be a leading force in finding and rolling out safe and effective treatments for Covid-19, with life-saving treatments dexamethasone and tocilizumab identified by our research. The government-funded PRINCIPLE trial presents an exciting opportunity to find treatments outside of hospital, stopping people’s symptoms from worsening at an earlier stage of the disease.

“The expansion of the trial, with a new treatment arm that is open to a wider patient cohort, is a promising development - I encourage as many eligible people as possible over the age of 18 to sign up to the trial and play a vital role in finding more treatments for this terrible virus.”

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 with the trial team in Oxford.

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 www.principletrial.org or call 0800 138 0880.