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

Stopped early · Phase 2/Phase 3 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT04615949

Run by

Cardiol Therapeutics Inc.

People needed

90

Starts

2021-04-30

Expected to finish

2022-11-30

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Valleywise Health Medical Center — Phoenix, Arizona, United States
• JY Research Institute — Cutler Bay, Florida, United States
• Westchester General Hospital — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• University of Texas Health Science Center — San Antonio, Texas, United States
• Baylor Scott & White Health - Temple — Temple, Texas, United States
• Science Valley Research Institute — Campo Largo, Paraná, Brazil
• Universidade Estadual de Maringa — Maringá, Paraná, Brazil
• Hospital São Lucas PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
• Irmandade Santa Casa de Misericórdia — Porto Alegre, Rio Grande do Sul, Brazil
• Núcleo de Ensino e Pesquisa do Instituto Mário Penna — Conjunto ACM, Santa Maria, Brazil
• Fundação Pio XII - Hospital de Amor Barretos — Barretos, São Paulo, Brazil
• IPECC-Instituto de Pesquisa Clínica de Campinas — Campinas, São Paulo, Brazil
• Instituto do Coração do HCFMUSP — Cerqueira César, São Paulo, Brazil
• SVRI- Irmandade de Santa Casa de Misercordia de Santos — Jabaquara, São Paulo, Brazil
• Science Valley Research Institute — Santo André, São Paulo, Brazil
• Fundação Faculdade Regional de Medicine de Sao Jose do Rio Preto (SJRP) — São José do Rio Preto, São Paulo, Brazil
• Complexo Hospitalar de Niteroi- Centro de Pesquisa Clinica — Rio de Janeiro, Brazil
• TecSalud — Monterrey, Nuevo León, Mexico

Full record on ClinicalTrials.gov

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