As this low-cost common gout drug presents itself as a potential treatment to fight coronavirus, this recognition by the Foundation will enable MHI to bring this research to a greater number of people affected by COVID-19, especially in areas where the population is more vulnerable due to health and economic inequities.
The COVID-19 Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, with funding from an array of public and philanthropic donors, to speed up the response to the COVID-19 pandemic by funding the identification, assessment, development and scale up of treatments.
"ColCorona exemplifies how we can look to bring scientific breakthroughs in a time- and cost-effective manner to patients by repurposing older drugs," said Dr. Jean-Claude Tardif, Director of the Research Center at MHI, Professor of Medicine at the University of Montreal, and ColCorona primary investigator. "We are at a critical juncture in searching for a treatment for patients with coronavirus and I, along with my colleagues involved in ColCorona around the world, are hopeful that colchicine will prove to have a positive effect on the serious inflammation seen in COVID-19, potentially keeping patients out of the ICU and ultimately saving lives."
The hypothesis is 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 clinical study is contact-less and is done from home. MHI is currently assessing several sites and support associations in which assistance for patients wanting to join the study can be provided. Anyone interested in receiving more information or wanting their association to be considered can call 1 877 536 6837 to find out more.
The patient eligibility criteria for the study are:
Women of child bearing potential 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, CGI and the U.S. National Institutes of Health (NIH).
COVID-19 Therapeutics Accelerator donors include the Bill & Melinda Gates Foundation, Wellcome, Mastercard, U.K. Department for International Development, Chan Zuckerberg Initiative, Michael & Susan Dell Foundation, Avast, Zhang Yiming, Alwaleed Philanthropies, EQT and Madonna.
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 and 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. Patients will be randomly assigned to 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, taking into account 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 and the largest cardiovascular genetics center in the country. 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
Note to media: ColCorona Clinical Trial is available in Montreal, New York Tri State Area (NYU Langone), New Jersey and Connecticut, California (UCSF), Madrid (Spain), British Columbia, Ontario and Alberta. Lead investigators in each city are available for interviews.
Source: Montreal Heart Institute
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