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

NCT04615949 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CARDIOL 100-03
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 20

Brief 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.

Conditions

COVID-19; Cardiovascular Diseases; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Composite of All-cause Mortality, Requirement for ICU Admission and/or Ventillatory Support and Cardiovascular Complications

  Proportions of patients in each group not having one of the outcome measures as described above (All-cause mortality, requirement for ICU admission and/or ventillatory support and cardiovascular complications)

  28 days post randomization

Secondary Outcomes (1)

• Ordinal Outcome Scale

  28 days

Study Arms (2)

Cannabidiol, pharmaceutically produced with < 5 ppm THC

EXPERIMENTAL

CardiolRx

Drug: Cannabidiol, pharmaceutically produced with < 5 ppm THC

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Cannabidiol, pharmaceutically produced with < 5 ppm THC DRUG

CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food

Also known as: CardiolRx

Cannabidiol, pharmaceutically produced with < 5 ppm THC

Placebo DRUG

Placebo 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cardiol Therapeutics Inc.: lead

Study Sites (20)

Valleywise Health Medical Center

Phoenix, Arizona, 85008, United States

Location

JY Research Institute

Cutler Bay, Florida, 33189, United States

Location

Westchester General Hospital

Miami, Florida, 33155, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62769, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Baylor Scott & White Health - Temple

Temple, Texas, 76508, United States

Location

Science Valley Research Institute

Campo Largo, Paraná, 83606, Brazil

Location

Universidade Estadual de Maringa

Maringá, Paraná, 87020-900, Brazil

Location

Hospital São Lucas PUCRS

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Location

Irmandade Santa Casa de Misericórdia

Porto Alegre, Rio Grande do Sul, Brazil

Location

Núcleo de Ensino e Pesquisa do Instituto Mário Penna

Conjunto ACM, Santa Maria, 30380-472, Brazil

Location

Fundação Pio XII - Hospital de Amor Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

IPECC-Instituto de Pesquisa Clínica de Campinas

Campinas, São Paulo, 13060-080, Brazil

Location

Instituto do Coração do HCFMUSP

Cerqueira César, São Paulo, 05403-000, Brazil

Location

SVRI- Irmandade de Santa Casa de Misercordia de Santos

Jabaquara, São Paulo, 1409, Brazil

Location

Science Valley Research Institute

Santo André, São Paulo, 1409, Brazil

Location

Fundação Faculdade Regional de Medicine de Sao Jose do Rio Preto (SJRP)

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Complexo Hospitalar de Niteroi- Centro de Pesquisa Clinica

Rio de Janeiro, 24020, Brazil

Location

TecSalud

Monterrey, Nuevo León, 64718, Mexico

Location

MeSH Terms

Conditions

COVID-19; Cardiovascular Diseases

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Limitations and Caveats

The study was closed prematurely because eligible patients could no longer be recruited due to vaccinations.

Results Point of Contact

• Title: Andrea B. Parker, MSc. PhD, Senior Director Clinical Operations
• Organization: CardiolRx

andrea.parker@cardiolRx.com

+1 289 9100862

Study Officials

• Dennis McNamara, MD

  University of Pittsburgh

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, parallel study, randomization 1:1

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 4, 2020
• Study Start: April 30, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 21, 2026
• Results First Posted: July 25, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available in Q4 2022
• Access Criteria: Access to the journal in which article has been published

Locations

ME (1); US (7); BR (12)