The Montreal Heart Institute (MHI) Research Center has extended its COLCORONA COVID-19 clinical trial to a third Canadian province being Ontario. As of today, Ontarians who are tested positive for COVID-19, but are not hospitalized, may be eligible for this innovative, contactless at-home study.
COLCORONA, initiated by Dr. Jean-Claude Tardif at the Montreal Heart Institute in Canada, is evaluating whether colchicine will reduce the rate of hospitalization of individuals recently diagnosed with COVID-19. The hypothesis that colchicine may prevent the phenomenon of major inflammatory storm responsible for severe complications seen in patients with COVID-19. This is one of the few current studies of COVID-19 infection in which non-hospitalized individuals can participate.
The Ontario Investigators who are collaborating with Dr. Tardif and his MHI team are:
Dr. Saswata Deb (MD, PhD, Senior Resident Physician, Dept of Family and Community Medicine, Sunnybrook Health Sciences Centre, UofT)
Dr. Barry Pakes (MD, PhD, Public Health, Assistant Professor, Program Director of Public Health and Preventive Medicine, UofT)
Dr. Stephen Fremes (MD, MSc, Cardiac Surgeon, Sunnybrook Health Sciences Centre, UofT)
There are now numerous sites across Canada, the United States and Spain taking part in the trial. Dr. Tardif and the MHI are working to also bring this clinical trial to other provinces/sites as soon as possible.
The participant eligibility criteria for the study is as follows:
- Test positive for COVID-19
- Be 40 years and over
- Not hospitalized
- Be willing to take the drug or placebo daily for 30 days
- Be willing to participate in two follow-up calls by phone or videoconference.
Women who do not take contraceptives, those who are pregnant, or those who are breastfeeding are not eligible for the trial. Physicians with patients, or people with a positive COVID-19 diagnosis who are interested in participating in the clinical study, can call the hotline any time at 1-877-536-6837.
For more information on COLCORONA clinical trial, visit www.colcorona.net
COLCORONA is coordinated by the Montreal Health Innovations Coordinating Center (MHICC), funded by the Government of Quebec, and supported by Pharmascience and CGI.
Colchicine is a generic, orally administered anti-inflammatory medication that is currently indicated for the management of pericarditis, gout, and familial Mediterranean fever. It is not a non-steroidal anti-inflammatory medicine. Colchicine was recently studied in the COLCOT study (published in the New England Journal of Medicine), which compared colchicine 0.5mg daily to placebo on top of standard of care in preventing ischemic cardiovascular events in patients with a recent myocardial infarction (MI).
COLCORONA is a randomized, double-blind, placebo-controlled study. It was initiated by Dr. Jean-Claude Tardif, Director of the MHI Research Center and Professor of Medicine at the University of Montreal. It aims to determine if colchicine may prevent the phenomenon of major inflammatory storm observed in adults suffering from serious complications linked to COVID-19. The clinical trial requires the recruitment of 6,000 patients who meet all the inclusion criteria and none of the exclusion criteria. They will be randomly assigned and given either colchicine or a placebo (1:1 ratio) for 30 days. Evaluations by phone or videoconference will then take place 15 and 30 days after the randomization. The sample size will allow researchers to detect if there is a reduction of at least 25% in the risk of events, considering a 7% event rate in the placebo group. The study will be monitored by a data monitoring committee (DMC) that includes experienced clinical researchers.
About the Montreal Heart Institute
Founded in 1954, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training, and prevention. It houses the largest research center in Canada, the largest cardiovascular prevention center in the country, and a cardiovascular genetics center. The Institute is affiliated with the University of Montreal and has more than 2,000 employees, including 245 doctors and more than 85 researchers.
About the Montreal Health Innovations Coordinating Center (MHICC):
The Montreal Health Innovations Coordinating Center (MHICC) is a leading academic clinical research organization and an integral part of the Montreal Heart Institute (MHI). The MHICC possesses an established network of collaborators in over 4,500 clinical sites in more than 30 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials, and drug repurposing.
Founded in 1983, Pharmascience Inc. is the largest pharmaceutical employer in Quebec. With its head office located in Montreal and its 1,500 employees, Pharmascience Inc. is a private, full-service pharmaceutical company with deep roots in Canada, and whose global reach is growing, in part thanks to the distribution of its products in more than 60 countries. Ranked 56th among the top 100 Canadian investors in research and development (R&D) thanks to $ 43 million investment in 2018, Pharmascience Inc. is the 4th largest manufacturer of over-the-counter generic drugs in the country. www.pharmascience.com
Founded in 1976, CGI is one of the world’s largest information technology (IT) and management consulting firms. From hundreds of locations around the world, CGI offers a complete portfolio of services and solutions: strategic IT and management consulting services, systems integration services, intellectual property solutions as well as IT and business process management services in delegated mode. www.cgi.com/canada