Viral Infection and CVD
COVID-19 is much more severe for those with cardiovascular disease (CVD) than for those without CVD. It is estimated that 30 – 40% of patients who die from COVID-19 do so from cardiovascular complications.
COVID-19, a disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is considered primarily a respiratory disease. However, an increasing number of reports indicate that COVID-19 patients are at higher risk of developing cardiovascular complications, and COVID-19 is found to be more deadly for those with cardiovascular disease (CVD) than for those without CVD.
In September 2020, the Corporation received clearance from the U.S. Food and Drug Administration (the “FDA”) for its Investigational New Drug (“IND”) application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of its lead product, CardiolRx™, in hospitalized COVID-19 patients with a prior history of, or risk factors for, CVD. CardiolRx is an oral cannabidiol formulation that is pharmaceutically manufactured under cGMP. Learn more…
Patients with COVID-19 present primarily 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 lungs. 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, which are frequently fatal. A strategy to prevent or limit the number or severity of these cardiovascular complications is likely to considerably improve outcomes from this disease.
The rationale for the clinical program of cannabidiol as a therapeutic approach to the treatment of COVID-19 is based upon the reported anti-inflammatory effect of cannabidiol. In addition, cannabidiol has a cardio-protective effect and, therefore, it is anticipated that this cannabinoid may prevent COVID-19-related cardiovascular complications thereby reducing morbidity and mortality. Cardiovascular complications such as myocardial injury as reflected by elevated serum troponin are common in patients with COVID-19, and it has been demonstrated that patients with myocardial injury suffer a higher rate of mortality. CBD has been shown in models to be protective against cardiotoxicity, significantly reducing elevated serum troponin T and reducing pro-inflammatory responses in the heart. CBD has also been shown to attenuate a number of measures of potential importance in the treatment of heart failure, including cardiac dysfunction, oxidative stress, fibrosis, and inflammatory and cell death signaling pathways in models of diabetes, a common co-morbidity in cardiovascular disease and COVID-19 patients.
An independent Clinical Steering Committee comprising eight highly distinguished thought leaders in cardiology from the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, the University of Pittsburgh Medical Center, and Charité University Medicine Berlin, has been established to design, oversee, and guide Cardiol’s Phase II/III trial.