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

TerminatedPhase 2, Phase 3

Sponsor: Cardiol Therapeutics Inc.

Conditions: COVID-19, Cardiovascular Diseases, Cardiovascular Risk Factor

Interventions: Cannabidiol, pharmaceutically produced with < 5 ppm THC, Placebo

Countries: United States, Brazil, Mexico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1\. Males and females 18 years of age or older 2. Hospitalized for COVID-19 with the most recent test positive\*; not receiving or likely to receive invasive mechanical ventilation within the next 24 hours 3. Prior history of at least one of: i) CVD \[cardiovascular (CV), cerebrovascular or peripheral vascular diagnoses\], ii) Age \> 64, iii) Diabetes (DM), iv) Hypertension (HTN), v) Abnormal serum lipids, vi) Obesity (BMI \> or equal 30 or waist circumference \>102 cm \[40"\] for men and \>88 cm \[35"\] for women), vii) Current smoker

\* Must be PCR test.

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
11. Chronic renal failure, determined as eGFR \< 30 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, remdesivir, baricitinib plus remdesivir, convalescent plasma or monoclonal antibodies against the SARS-CoV-2 virus or any other therapy approved under emergency use in the region for treatment of COVID-19
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
24. Any cannabinoid intake in the past month
25. Body weight \> 170 kg

Locations (20)

Phoenix, Arizona, United States
Cutler Bay, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Springfield, Illinois, United States
San Antonio, Texas, United States
Temple, Texas, United States
Campo Largo, Paraná, Brazil
Maringá, Paraná, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Conjunto ACM, Santa Maria, Brazil
Barretos, São Paulo, Brazil
Campinas, São Paulo, Brazil
Cerqueira César, São Paulo, Brazil
Jabaquara, São Paulo, Brazil
Santo André, São Paulo, Brazil
São José do Rio Preto, São Paulo, Brazil
Rio de Janeiro, Brazil
Monterrey, Nuevo León, Mexico