Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors

Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization.

Screening (Day 0-1): Patients hospitalized for COVID-19 within the past 24 hours will be screened. If patient consent can be obtained, baseline assessments will be carried out: Physical examination (including vital signs), ECG including QTc interval assessment, echocardiogram to measure left-ventricular ejection fraction (LVEF), chest X-ray, local laboratory (including CBC, AST/ALT, alkaline phosphatase, bilirubin, creatinine/eGFR, INR, pregnancy test (in women with child-bearing potential only), lymphocyte count and LDH. A C-SSRS will also be completed. Frozen plasma will be retained for central analysis of CardiolRx™ levels, hs-troponin, NT-proBNP, D-dimer as well as inflammatory markers (hs-CRP, ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10).

If all eligibility criteria are met, the patient will be randomized to either CardiolRx™ or placebo.

Study treatment will be initiated immediately after all baseline assessments have been completed and the patient is randomized (Day1). Oral administration is as follows:

* Day 1 and Day 2: Initial dose: 2.5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo * Day 3 and Day 4: Increased to 5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo * Day 5 to Day 28: Increased to 7.5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo For the first 7 days and on Day 10, an ECG will be recorded 4 hours post morning dose with QTc intervals measured. If the QTc interval is \>500 msec or an increase of \> 60 msec from baseline is observed, the study medication must be stopped immediately.

If the next higher dose is not tolerated for other reasons, the dose will be reduced to the previous tolerated dose. The highest tolerated dose will be administered until Day 28.

If the patient is discharged before Day 10, the assessments up to Day 10 will be carried out as home visits. After Day 10, all remaining scheduled assessments will be carried out during out-patient visits (or home visits, if out-patient visits are not feasible).

In addition to prolongation of the QTc intervals, careful observation is required to detect other Adverse Drug Reactions (ADRs) and Drug-Drug Interactions (DDIs). Because CardiolRx™, may inhibit the metabolism of other drugs, new symptoms may represent toxicity from a concomitant medication that had previously been well tolerated.