Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors
COVID-19, Cardiovascular Diseases, Cardiovascular Risk Factor
About this trial
This is an interventional prevention trial for COVID-19
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:
- Patients who have received vasopressors, extracorporeal membrane oxygenation and mechanical ventilation within last 30 days
- Background of cardiac transplant surgery
- Implanted defibrillator (ICD) in the last three months
- Implanted left-ventricular assist device (LVAD)
- Acute coronary syndrome (ACS) within 30 days
- Percutaneous coronary intervention (PCI) within 30 days
- Receiving any immuno-suppressive agent other than dexamethasone
- History of QTc interval prolongation
- QTc interval > 500 msec
- Treated with strong inducers of CYP3A4 or CYP2C19
- Chronic renal failure, determined as eGFR < 30 ml/min
- 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
- Bacterial sepsis, defined as documented bacteremia at the time of presentation or other active bacterial infection
- 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
- Inability or unwillingness to give informed consent
- Ongoing drug, alcohol or cannabis abuse
- Women who are pregnant or breastfeeding
- Any factor, which would make it unlikely that the patient can comply with the study procedures
- Hemoglobin <8.5 gm/dL
- Leukocyte count < 3000/ mm3
- Platelets < 100,000 / mm3
- Current diagnosis of cancer, with the exception of non-melanoma skin cancer
- Showing suicidal tendency as per the Columbia-Suicide Severity Rating Scale (C-SSRS) administered at screening
- Any cannabinoid intake in the past month
- Body weight > 170 kg
Sites / Locations
- Valleywise Health Medical Center
- JY Research Institute
- Westchester General Hospital
- University of South Florida
- Prairie Education and Research Cooperative
- University of Texas Health Science Center
- Baylor Scott & White Health - Temple
- Science Valley Research Institute
- Universidade Estadual de Maringa
- Hospital São Lucas PUCRS
- Irmandade Santa Casa de Misericórdia
- Núcleo de Ensino e Pesquisa do Instituto Mário Penna
- Fundação Pio XII - Hospital de Amor Barretos
- IPECC-Instituto de Pesquisa Clínica de Campinas
- Instituto do Coração do HCFMUSP
- SVRI- Irmandade de Santa Casa de Misercordia de Santos
- Science Valley Research Institute
- Fundação Faculdade Regional de Medicine de Sao Jose do Rio Preto (SJRP)
- Complexo Hospitalar de Niteroi- Centro de Pesquisa Clinica
- TecSalud
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Cannabidiol, pharmaceutically produced with < 5 ppm THC
Placebo
CardiolRx
Placebo