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Cardiol Therapeutics Announces Formation of Data Safety Monitoring and Clinical Endpoint Committees for Phase II/III Outcomes Trial in High-Risk Patients Hospitalized with COVID-19
Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hos...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Cardiol Therapeutics Announces Formation of Data Safety Monitoring and Clinical Endpoint Committees for Phase II/III Outcomes Trial in High-Risk Patients Hospitalized with COVID-19Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular diseaseOakville, Ontario--(Newsfile Corp. - January 21, 2021) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) (\"Cardiol\" or the \"Company\"), a clinical-stage biotechnology company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease, today announced the formation of the Data Safety Monitoring Committee (\"DSMC\") and the Clinical Endpoint Committee (\"CEC\") for the Company's Phase II/III trial in high-risk patients hospitalized with COVID-19 at clinical centers throughout the United States.The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial. In order to do so, the DSMC may review unblinded study information (on a patient level or treatment group level) during the conduct of the trial. After each data review, the DSMC will advise the study Steering Committee with recommendations for protocol modifications, if concerns over safety have developed, or that the study should continue according to the protocol if no concerns are identified. The DSMC will also perform an interim analysis after 200 patients have completed the study, to determine if the study is likely to enroll enough patients to achieve statistical significance or if additional patients should be recruited. The DSMC currently consists of three members:Chair: Dr. Jean Lucien Rouleau - Professor and Former Dean, University of Montreal and Cardiologist, Montreal Heart Institute. Dr. Rouleau has an international reputation in cardiovascular research, particularly in the field of both basic mechanisms and improving the clinical care of patients with heart failure. His publication list includes more than 475 articles and 7 book chapters.Statistician: Dr. George Wells - Professor, School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa and Director, Cardiovascular Research Methods Centre, University of Ottawa Heart Institute. Dr....