Montreal Heart Institute in Canada has said that the COLCORONA clinical study, assessing colchicine, will continue enrolment of non-hospitalised adults with Covid-19.
The announcement is based on a recommendation from the independent data monitoring committee (DMC) following a futility analysis.
COLCORONA is coordinated by the Montreal Health Innovations Coordinating Center (MHICC) with funding from the Government of Quebec, the Bill & Melinda Gates Foundation, and the US’ National Heart, Lung, and Blood Institute (NHLBI).
In addition, the trial is being conducted in collaboration with CGI and Pharmascience.
COLCORONA primary investigator Dr Jean-Claude Tardif said: “We are pleased to have achieved this important milestone and now await the final results of COLCORONA to determine the effect of colchicine in preventing complications in non-hospitalised patients with Covid-19.
“We are committed to including large number of patients worldwide in this robust study to determine the effect of colchicine on the serious inflammatory storm seen with Covid-19, potentially keeping patients out of the hospital and ultimately saving lives.”
The COLCORONA study is a contact-free, at-home, randomised, double-blind, placebo-controlled study being performed at several sites in Canada, the US, Europe, South America, and Africa.
It is designed to assess the ability of colchicine to prevent the major inflammatory storm that develops in adults with serious complications due to Covid-19. Participants must be aged 40 years and above.
The primary objective is to investigate if short-term treatment with the medication can decrease the rate of death and lung complications caused by Covid-19. Colchicine will be compared to placebo.
In May this year, the Canadian Center for Vaccinology (CCfV) at Dalhousie University obtained approval from Health Canada to conduct the country’s first clinical trials of a potential Covid-19 vaccine.