Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04615949
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
Cardiol Therapeutics Inc.

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.

Condition or disease Intervention/treatment Phase
COVID-19 Cardiovascular Diseases Cardiovascular Risk Factor Drug: Cannabidiol, pharmaceutically produced with < 5 ppm THC Drug: Placebo Phase 2 Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled, parallel study, randomization 1:1
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Prevention
Official Title: Study to Evaluate the Efficacy and Safety of CardiolRx™ in Patients With COVID-19 and Cardiovascular Disease or Risk Factors A Double-blind, Placebo-controlled Trial
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: Cannabidiol, pharmaceutically produced with < 5 ppm THC
CardiolRx
Drug: Cannabidiol, pharmaceutically produced with < 5 ppm THC
CardiolRx 2.5 mg/kg to 7.5 mg/kg of body weight b.i.d taken orally with food
Other Name: CardiolRx

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




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 28 days post randomization ]
    proportions of patients not surviving

  2. Requirement for ICU admission and/or ventilatory support [ Time Frame: 28 days post randomization ]
    Proportions of patients needing ICU admission and/or ventilatory support

  3. CV complications [ Time Frame: 28 days ]
    HF, AMI, myocarditis, new sustained arrhythmia or stroke



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04615949


Contacts
Layout table for location contacts
Contact: Andrea B Parker, PhD 289-910-0862 andrea.parker@cardiolrx.com
Contact: Andrew Hamer, MD 289-910-0380 andrew.hamer@cardiolrx.com

Locations
Layout table for location information
United States, Arizona
Valleywise Health Medical Center Recruiting
Phoenix, Arizona, United States, 85008
Contact: Mary Mulrow, RN    602-344-5058    Mary.Mulrow@valleywisehealth.org   
Contact: Amanda Frary, RN    602-344-5058    Amanda.Frary@valleywisehealth.org   
Principal Investigator: Dale Stern, MD         
Sub-Investigator: Stacey Klein, MD         
Sub-Investigator: Jennifer Smith, MD         
United States, Florida
Westchester General Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Maria Bertoli    786-474-2612    maria.bertoli@westchesterhospital.com   
Contact: Avnish Jetty    (954) 609-1968    avnish.jetty@westchesterhospital.com   
Principal Investigator: Jose Suarez, MD         
Sub-Investigator: Aimee Gonzalez, MD         
Sub-Investigator: Mary Villar Zamora, MD         
Sub-Investigator: Alicia Mustafa, RN         
Sub-Investigator: Deborah Soto, RN         
Med-Care Research Not yet recruiting
Miami, Florida, United States, 33165
Contact: Daniela Urra    305-221-0660    durra@medcareresearch.com   
Principal Investigator: Felix Chion-Fong         
University of South Florida Recruiting
Tampa, Florida, United States, 33613
Contact: Thanh Tran    813-844-8544    tqtran@usf.edu   
Contact: Rachel Hutton       rachelhutton@usf.edu   
Principal Investigator: Guilherme Oliveira, MD         
Sub-Investigator: Robby Wu, MD         
Sub-Investigator: Dae Hyun Lee, MD         
Sub-Investigator: Nhi Tran, MD         
Sub-Investigator: Avennette Pinto, MD         
Sub-Investigator: Beth Montera, MD         
United States, Illinois
Prairie Education and Research Cooperative Active, not recruiting
Springfield, Illinois, United States, 62769
United States, Indiana
Lutheran Health Physicians Not yet recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Terrie Ross, BN    260-458-3580    tross2@lhn.net   
Contact: Amber Modricker-Campbell    260-435-2649    acampbell@lutheran-hosp.com   
Principal Investigator: Vincente Rodriquez, MD         
Sub-Investigator: Eustace Fernandesv, MD         
United States, New York
Montefiore Medical Center (MMC) Active, not recruiting
Bronx, New York, United States, 10467
United States, Texas
PRX Research/Dallas Regional Medical Center Recruiting
Mesquite, Texas, United States, 75149
Contact: Muhammed Saeed, MD    972-777-4428    admin@prxresearch.com   
Contact: Jennifer Choe    972-777-4428    jennifer@prxresearch.com   
Principal Investigator: Adeel Shibli, MD         
Sub-Investigator: Mustafa Awili, MD         
Sub-Investigator: Michael Carroll, MD         
Sub-Investigator: Linda Michelle Deane, RN         
University of Texas Health Science Center Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Robin Tragus    210-567-5262    tragus@uthscsa.edu   
Principal Investigator: Jan Patterson, MD         
Sub-Investigator: Allen Anderson, MD         
Sub-Investigator: Thomas Patterson, MD         
Sub-Investigator: Irma Scholler, RN         
Baylor Scott & White Health - Temple Not yet recruiting
Temple, Texas, United States, 76508
Contact: Margarite Grable    254-724-5861    Margarite.Grable@BSWHealth.org   
Principal Investigator: Shekhar Ghamande         
Sponsors and Collaborators
Cardiol Therapeutics Inc.
Investigators
Layout table for investigator information
Study Chair: Dennis McNamara, MD University of Pittsburgh
Layout table for additonal information
Responsible Party: Cardiol Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04615949    
Other Study ID Numbers: CARDIOL 100-03
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will become available once the study has been published
Supporting Materials: Study Protocol
Time Frame: Data will become available in Q4 2021
Access Criteria: Access to the journal in which article has been published

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Cardiovascular Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cannabidiol
Anticonvulsants