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

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiol Therapeutics Inc.
• Treatments: Cannabidiol

Criteria

Inclusion Criteria:

1. Males and females 18 years of age or older

2. Tested positive and hospitalized for COVID-19 within the past 24 hours; illness severity must be less than indicated for intensive care unit (ICU) admission

3. Prior history of CVD [cardiovascular (CV), cerebrovascular or peripheral vascular diagnoses], and/or significant risk factors for CVD [age > 64, diabetes (DM), hypertension (HTN), abnormal serum lipids, obesity (BMI greater than 30)]

Exclusion Criteria:

1. Patients who have received vasopressors, extracorporeal membrane oxygenation and mechanical ventilation within last 30 days

2. Background of cardiac transplant surgery

3. Implanted defibrillator (ICD) in the last three months

4. Implanted left-ventricular assist device (LVAD)

5. Acute coronary syndrome (ACS) within 30 days

6. Percutaneous coronary intervention (PCI) within 30 days

7. Receiving any immuno-suppressive agent other than dexamethasone

8. History of QTc interval prolongation

9. QTc interval > 500 msec

10. Treated with strong inducers of CYP3A4 or CYP2C19, as listed in Appendix 17.8

11. Chronic renal failure, determined as eGFR < 60 ml/min

12. Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) or ALT or AST >3x ULN plus bilirubin >2x ULN

13. Bacterial sepsis, defined as documented bacteremia at the time of presentation or other active bacterial infection

14. Current participation in any research study involving investigational drugs or devices with the exception of dexamethasone

15. Inability or unwillingness to give informed consent

16. Ongoing drug, alcohol or cannabis abuse

17. Women who are pregnant or breastfeeding

18. Any factor, which would make it unlikely that the patient can comply with the study procedures

19. Hemoglobin <8.5 gm/dL

20. Leukocyte count < 3000/ mm3

21. Platelets < 100,000 / mm3

22. Current diagnosis of cancer, with the exception of non-melanoma skin cancer

23. Showing suicidal tendency as per the Columbia-Suicide Severity Rating Scale (C-SSRS) administered at screening