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Findings from research by the PRINCIPLE Trial into treatment of COVID-19 in the community with the anti-inflammatory drug colchicine published in the British Journal of General Practice.

A picture of a tablet with colchicine written on it.

Findings from research by the PRINCIPLE Trial into treatment of COVID-19 in the community with the anti-inflammatory drug colchicine published in the British Journal of General Practice.

The Platform Randomised trIal of treatmeNts in the Community for epIdemic and Pandemic iLlnEsses (PRINCIPLE) found that colchicine, an anti-inflammatory drug widely used in the UK for many years as a treatment for acute gout, did not improve time to recovery in people at higher risk of complications with COVID-19 in the community.

The trial opened on 2 April 2020 and randomisation to the colchicine arm of the trial started on 4 March 2021 and stopped on 26 May 2021 because the prespecified time to recovery futility criterion was met.

Adults aged 65 years and over or aged 18 years and over with comorbidities or shortness of breath, and unwell for 14 days with suspected COVID-19 in the community, were randomised to usual care, usual care plus colchicine (500 µg daily for 14 days), or usual care plus other interventions. The co-primary endpoints were time to first self-reported recovery and admission to hospital/death related to COVID-19, within 28 days, analysed using Bayesian models.

The primary analysis model included 2755 participants who were COVID-19 positive, randomised to colchicine, usual care, and other treatments. Time to first self-reported recovery was similar in the colchicine group compared with usual care.

The probability of meaningful benefit in time to recovery was very low at 1.8% and COVID-19-related admissions to hospital/deaths were similar in the colchicine group versus usual care.

The findings were published in a paper in the British Journal of General Practice on 19 April 2022. To read the paper in full follow this link:

The Platform Randomised trIal of treatmeNts in the Community for epIdemic and Pandemic iLlnEsses (PRINCIPLE) Trial is led by the University of Oxford and funded by UK Research and Innovation (UKRI) and National Institute for Health Research (NIHR).