NCT04615949

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

Study to Evaluate the Efficacy and Safety of CardiolRx™ in Patients With COVID-19 and Cardiovascular Disease or Risk Factors A Double-blind, Placebo-controlled Trial

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Cardiol Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days.

Detailed description

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. A nasopharyngeal swab will also be done every day until Day 7 and on Day 14 to test for presence of the SARS-CoV-2 virus. After Day 7, assessments will be carried out on a weekly basis except for as noted above on Day 10. Frozen plasma will be retained for central analysis of CardiolRx™ levels, hs-troponin, NT-proBNP, D-dimer, inflammatory markers (hs-CRP, ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10) and additional parameters of interest every two days until Day 7 as well as on day 28. The assessments on Day 28 include the following: Physical examination (including vital signs), ECG (recorded 4 hours post morning dose for measurement of QTc interval), echocardiogram to measure LVEF, chest X-ray, local laboratory assessments, including CBC, AST/ALT, alkaline phosphatase, bilirubin, creatinine/eGFR, INR, lymphocyte count and LDH. In addition, a C-SSRS will be completed and the patient will be asked to answer a PICQ. Further follow-up visits are scheduled for Day 45 and Day 60 post randomization. These include a clinical assessment (including vital signs) as well as the completion of the PICQ (PICQ on Day 60 only). Any changes in concomitant medications and (S)AEs will also be recorded.

Conditions

• COVID-19
• Cardiovascular Diseases
• Cardiovascular Risk Factor

Interventions

Type	Name	Description
DRUG	Cannabidiol, pharmaceutically produced with < 5 ppm THC	CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
DRUG	Placebo	Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food

Timeline

• Start date: 2021-04-30
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2020-11-04
• Last updated: 2025-07-25
• Results posted: 2025-07-25

Locations

20 sites across 3 countries: United States, Brazil, Mexico

Regulatory

• FDA-regulated drug study