CRTPF - Cardiol Therapeutics sets up DSMC and CEC for mid-stage COVID-19 trial

Cardiol Therapeutics (CRTPF) announces the formation of Data Safety Monitoring Committee ((DSMC)) and the Clinical Endpoint Committees ((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, while CEC will include clinical experts in cardiology and intensive care.The CEC has been established to ensure accurate and consistent assessment of the trial endpoints and/or serious adverse events.Cardiol's double-blind, placebo-controlled Phase II/III clinical trial is designed to investigate the efficacy and safety of CardiolRx, a pharmaceutically produced extra strength cannabidiol formulation, in 422 hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease.The U.S. FDA had signed off on the trial in September last year.

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Cardiol Therapeutics sets up DSMC and CEC for mid-stage COVID-19 trial