ColCorona was initiated at MHI by Dr. Jean-Claude Tardif, director of the MHI Research Center and professor of medicine at the University of Montreal. It aims to determine whether colchicine has a preventive effect on the phenomenon of "major inflammatory storm" of the lungs, observed in adults suffering from serious complications linked to COVID-19. Researchers hypothesize that this drug used to treat gout may reduce the severe inflammatory complications associated with COVID-19, slow the progression of the disease, and save lives. Several sites in Canada, the United-States and Spain are participating in the clinical study.
"The support of the National Heart, Lung, and Blood Institute comes at a critical time", said Dr. Jean-Claude Tardif. "Time is of the essence to find an effective treatment for COVID-19 and the support from the NIH will allow us to accelerate our research efforts to confirm the potential of colchicine."
"I would like to thank the National Heart, Lung, and Blood Institute for its contribution to our study", said Dr. Binita Shah, Associate Director of Research, NYU Langone Cardiac Cath Lab at NYU Langone. "This support will allow us to deploy the necessary resources to make this potential treatment accessible to the greatest number of patients with COVID-19 in the New York City, and tri-state region, which is strongly affected by the pandemic."
The participant eligibility criteria for the study is as follows:
• Test positive for COVID-19 (or clinically diagnosed for Quebec and New York City tri-state regions)
• Be 40 years and over and have at least one high-risk criteria
• 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 clinical study. Physicians with patients, or people with a positive COVID-19 diagnosis who are interested in participating in the clinical study can call the hotline at any time at 1-877-536-6837.
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). The results showed that colchicine 0.5mg daily significantly reduces the risk of first ischemic cardiovascular events by 23% and total (first and recurrent) ischemic cardiovascular events by 34%.
COLCORONA is a randomized, double-blind, placebo-controlled study. which 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 for 30 days. Evaluations by phone or videoconference will then take place 15 and 30 days after the randomization. The study will be monitored by a data monitoring committee (DMC) that includes experienced clinical researchers from the Montreal Health Innovations Coordinating Center (MHICC). The study is funded by the Government of Quebec and supported by Pharmascience and CGI. www.colcorona.net
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. www.icm-mhi.org
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. www.mhicc.org
About NYU Langone Health
NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. Included in the 200+ locations throughout the New York area are six inpatient locations: Tisch Hospital, its flagship acute-care facility; Kimmel Pavilion, its state-of-the-art healthcare facility, opened in 2018; Rusk Rehabilitation, ranked as one of the top 10 rehabilitation programs in the country; NYU Langone Orthopedic Hospital, a dedicated inpatient orthopedic hospital with all musculoskeletal specialties ranked top 10 in the country; Hassenfeld Children's Hospital at NYU Langone, a comprehensive pediatric hospital supporting a full array of children's health services; and NYU Langone Hospital—Brooklyn, a full-service teaching hospital and level 1 trauma center located in Sunset Park, Brooklyn. Also part of NYU Langone Health is the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute-designated cancer center, and NYU Grossman School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history.
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
Source: Montreal Heart Institute
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