COLCORONA trial to examine whether colchicine can reduce complications associated with COVID-19, slow disease progression, and save patient lives

Montreal, Canada, and New-York City, USA. April 6th, 2020 - The Montreal Heart Institute (MHI) Research Center today announced a strategic partnership with the NYU Grossman School of Medicine in New York City for its COVID-19 clinical study to evaluate whether colchicine will have an effect on preventing the phenomenon of major inflammatory storm present in adults suffering from severe complications related to COVID-19.

The clinical study, named COLCORONA, will involve the recruitment of approximately 6,000 participants who will be followed for 30 days with initial results available a few days after study completion. COLCORONA was initiated on March 23, 2020 at the Montreal Heart Institute in Canada by Dr. Jean-Claude Tardif, Director of the Research Center at MHI and Professor of Medicine at the University of Montreal. Dr. Tardif is now partnering with Dr. Binita Shah, Associate Director of Research, NYU Langone Cardiac Cath Lab and Dr. Michael Pillinger, Professor of Medicine and Biochemistry and Molecular Pharmacology at NYU Langone to bring this study immediately to patients in New York City (NYC). As of today, the state of New York has over 130,000 people who are known to be COVID-19 positive. Dr. Tardif and the MHI are working to also bring this clinical trial to other regions as soon as possible.

The participant eligibility criteria for the study is as follows:

Test positive for COVID-19

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.

COLCORONA is coordinated by the Montreal Health Innovations Coordinating Center (MHICC) is funded by the Government of Quebec and supported by Pharmascience and CGI.

For more information on COLCORONA clinical trial, visit www.colcorona.org

About Colchicine

Colchicine is a generic, orally administered anti-inflammatory medication that is currently indicated for the management of pericarditis, gout, and familial Mediterranean fever. 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).

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. 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.

About Pharmascience

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

About CGI

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