Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis within 90 days of onset of symptoms will be screened and, if eligible, randomized to CardiolRx or placebo.
CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC<5 ppm). The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, 24-hour Holter assessments, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests.
The primary outcome parameters are measured by CMR. Secondary outcomes include clinical endpoints and changes in inflammatory and biomarkers.