A UK COVID-19 trial that is assessing the effectiveness of a common gout drug to help alleviate the virus’s symptoms can now include under-50s, it has been announced.
Led by the University of Oxford, 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 recovery time and severity of symptoms, in the hope of preventing the need for hospital admission.
Previously, only those aged 50 and over, and who were most at risk of complications, were eligible to join the trial if they tested positive for COVID-19.
But researchers have said that in the trial testing colchicine, an inexpensive anti-inflammatory drug used to treat acute gout, will now include participants aged 18-64 who either have shortness of breath from the illness or have certain underlying health conditions that put them at risk of severe illness. Participants are only eligible to join the trial during the first 14 days of COVID-19 illness.
It follows a promising trial in Canada, where the drug reduced hospital admissions in patients with COVID-19. However, little is known about its effectiveness in reducing recovery time or the burden of the illness.
Since launching in March 2020, PRINCIPLE has so recruited more than 4400 volunteers in the UK, making it the largest trial of COVID-19 treatments to take place in community settings.
PRINCIPLE trial co-lead Professor Chris Butler, a GP 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.”
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 in the UK with coronavirus symptoms, or who have a positive test result, can join the trial online, over the telephone or via their GP practice, without needing face-to-face visits.
The PRINCIPLE trial has so far determined that 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.
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