The Montreal Heart Institute (MHI) announces that the COLCORONA study results are published today in The Lancet Respiratory Medicine.
The article, which is entitled Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomized, double-blinded, adaptive, placebo-controlled, multicentre trial, concludes that, given the lack of oral therapies available to prevent COVID-19 complications among non-hospitalized patients and the observed benefit of colchicine in patients with a PCR-confirmed diagnosis of COVID-19, this anti-inflammatory drug could be considered as a treatment for those at risk of complications.
Given the current pandemic, while awaiting collective immunity through vaccination around the world, the need for treatments to prevent COVID-19 complications among patients who contract the disease remains. Our study showed that colchicine could be used to reduce the risk of complications for some patients with COVID-19.”
Dr. Jean-Claude Tardif, Director, MHI Research Centre, Professor, Faculty of Medicine, Université de Montréal
Tardif is also the Principal Investigator of COLCORONA.
Colchicine is an inexpensive and readily available anti-inflammatory drug. Orally administered, it is currently prescribed to treat gout, Familial Mediterranean Fever and pericarditis. The COLCORONA study assessed colchicine’s potential to reduce the risk of COVID-19-related complications in outpatients over 40 years of age with at least one risk factor for disease progression.
The study’s primary efficacy endpoint was the composite of death or hospitalization in patients with COVID-19. Of the 4,488 patients enrolled, including those without a PCR-confirmed diagnosis, the primary endpoint occurred in 4.7% of patients in the colchicine group and 5.8% of those in the placebo group, a non-statistically significant result.
For the 4,159 patients with a PCR-based diagnosis of COVID-19, the primary endpoint occurred in 4.6% of patients in the colchicine group and 6.0% of patients in the placebo group, a statistically significant result. Serious adverse events were reported in 4.9% of patients in the colchicine group and 6.3% of those in the placebo group.
Notwithstanding these results, it is recommended that studies such as this one be replicated in non-hospitalized patients with a PCR-confirmed diagnosis of COVID-19.
“The COLCORONA study expands on our knowledge of the role of oral, cheap and widely available repurposed drugs such as colchicine to treat people early on to prevent serious complications of COVID-19 and can help practitioners and their patients make informed treatment decisions,” said Yves Rosenberg, M.D., M.P.H., chief of the Atherothrombosis and Coronary Artery Disease Branch at the National Heart, Lung, and Blood Institute, part of the United States National Institutes of Health.
COLCORONA (NCT04322682) is a randomized, double-blinded, placebo-controlled, home-based clinical trial. It was conducted in Canada, the United States, Europe, South America, and South Africa.
The study included 4,488 non-hospitalized patients over 40 years of age with COVID-19 at the time of inclusion, with at least one identified risk factor for COVID-19 complications (e.g., diabetes, hypertension, known respiratory disease, obesity). Patients were randomized to receive colchicine (0.5mg twice daily for three days and once daily after) or placebo for 30 days.