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Cardiol Therapeutics Receives FDA Approval for Investigational New Drug (IND) Application for Phase II/III COVID-19 Trial
Trial will take place at major U.S. centers and examine the cardioprotective properties of Car...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Cardiol Therapeutics Receives FDA Approval for Investigational New Drug (IND) Application for Phase II/III COVID-19 TrialTrial will take place at major U.S. centers and examine the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease (CVD)Oakville, Ontario--(Newsfile Corp. - September 25, 2020) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) (\"Cardiol\" or the \"Company\"), a clinical-stage biotechnology company focused on developing innovative therapies for inflammatory heart disease, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating 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 (CVD). The trial will take place at major centers in the United States, where the prevalence of COVID-19 remains high. Patients with COVID-19 primarily present with respiratory symptoms which can progress to bilateral pneumonia and serious pulmonary complications. It is now recognized that the impact of COVID-19 is not limited to the pulmonary system. Individuals with pre-existing CVD or who have risk factors for CVD (such as diabetes, hypertension, obesity, abnormal serum lipids, or age greater than 64) are at significantly greater risk of developing serious disease from COVID-19 and experience greater morbidity. Moreover, such COVID-19 patients are at significant risk of developing cardiovascular complications (such as acute myocardial infarction, cardiac arrhythmias, myocarditis, stroke, and heart failure) during the course of their illness, and which are frequently fatal, with an estimated 30 - 40% of patients who die from COVID-19 doing so from cardiovascular complications. A strategy to prevent or limit the number or severity of these cardiovascular complications is likely to considerably improve outcomes from this disease. Cardiol's Phase II/III trial has been designed to assess the efficacy, safety, and tolerability of CardiolRx™ in preventing cardiovascular complications in hos...