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PRINCIPLE COVID-19 treatments trial widens to include under 50s

Published: 03 March 2021

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.”

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.”

Participants are only eligible to join the trial during the first 14 days of COVID-19 illness. 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 online, over the telephone or via their GP practice from anywhere in the UK.

The PRINCIPLE trial has found no benefit from antibiotics azithromycin and doxycycline for COVID-19. The trial continues to investigate budesonide, an inhaled corticosteroid, in people aged over 50.

PRINCIPLE: Urgent public health research

The PRINCIPLE trial is jointly funded by UK Research and Innovation (UKRI) and the NIHR. As a prioritised urgent public health study, delivery of the study is also supported by the NIHR Clinical Research Network and the devolved administrations - with 3,800 participants across the UK taking part so far.

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