The Montreal Heart Institute (ICM) announces that the results of the COLCORONA study are published in “The Lancet Respiratory Medicine”. The article titled “Colchicine for Outpatients with COVID-19 (COLCORONA): A Phase 3, Randomized, Double-blind, Adaptive, Placebo-Controlled Multicenter Trial”, concludes that, given the absence of oral therapies to prevent complications of COVID-19 in outpatients and the benefit of colchicine observed in patients with a confirmed diagnosis of COVID-19 by PCR test, this anti-inflammatory could be considered as treatment in people at risk of complications.
“In the current context of the pandemic, pending collective immunity through vaccination on a global scale, there remains a need for treatments to prevent complications of COVID-19 in patients who contract the disease,” said Dr Jean-Claude Tardif, Director of the ICM Research Center, Professor at the Faculty of Medicine of the University of Montreal and Principal Investigator of COLCORONA. “Our study has shown that colchicine may add to the arsenal of available therapies to reduce the risk of complications in some patients with COVID-19. “
Colchicine is an inexpensive and readily available anti-inflammatory drug. Administered orally, it is currently indicated for the treatment of gout, familial Mediterranean fever and pericarditis. The COLCORONA study evaluated the potential of colchicine to reduce the risk of complications from COVID-19 in out-of-hospital patients over 40 years of age with at least one risk factor for worsening the disease.
The primary efficacy endpoint of the study was the combination of death or hospitalization in patients with COVID-19. Out of a total of 4,488 patients recruited, including those without a diagnosis confirmed by PCR test, the primary endpoint occurred in 4.7% of patients in the colchicine group and in 5.8% of those in the placebo group. , a result not statistically significant. For the 4,159 patients with a confirmed diagnosis of COVID-19 by PCR test, the primary endpoint occurred in 4.6% of patients in the colchicine group and in 6.0% of those in the placebo group, a statistically significant result. Serious adverse events were reported in 4.9% of patients in the colchicine group and in 6.3% of those in the placebo group. Notwithstanding these results, replication of studies like this one in out-of-hospital patients with a diagnosis of COVID-19 confirmed by PCR testing is recommended. All the results of the study are available here: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00222-8/fulltext.
“The COLCORONA study expands our knowledge of the role that repositioning affordable, widely available oral medications, such as colchicine, may have in treating people early to prevent serious complications from COVID-19 and may help practitioners and their patients to make informed treatment decisions, ”said Dr. Yves Rosenberg, chief executive officer of the atherothrombosis and coronary heart disease department at the National Heart, Lung, and Blood Institute, part of the National Institutes of Health in the United States.
COLCORONA was coordinated by the Center de Coordination des Essais Cliniques de Montréal (MHICC) of the ICM, funded by the Government of Quebec, the National Heart, Lung, and Blood Institute of the American National Institutes of Health (NIH), the philanthropist Montrealer Sophie Desmarais as well as the COVID-19 Therapeutics Accelerator, an initiative launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard. The companies CGI, Dacima and Pharmascience of Montreal were also collaborators in the study.