Cannabidiol Treatment for Severe and Critical Coronavirus (COVID-19) Pulmonary Infection
1 other identifier
interventional
40
1 country
1
Brief Summary
Current management of COVID-19 (coronavirus) is mainly supportive, and respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of mortality. Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with severe acute respiratory syndrome (SARS). Cannabidiol (CBD), a nonpsychotropic ingredient of Cannabis sativa, possesses potent anti-inflammatory and immunosuppressive properties. These effects are mediated by T cell attrition and by inhibition of pro-inflammatory cytokine release (tumor necrosis factor-a, Interferon gamma, IL-1b, IL-6, and IL-17) and stimulation of anti-inflammatory cytokine production (IL-4, IL-5, IL-10, and IL-13). In a number of phase 2 trials involving more than 100 patients, our group was able to show the safety and efficacy of CBD in the prevention and treatment of graft-versus-host disease. Based on these data, we will test the cytokine profile, safety and efficacy of CBD treatment in patients with severe and critical COVID-19 infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 covid19
Started Jan 2021
Typical duration for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2021
CompletedFirst Submitted
Initial submission to the registry
January 28, 2021
CompletedFirst Posted
Study publicly available on registry
January 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedJanuary 29, 2021
January 1, 2021
12 months
January 28, 2021
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
Serum C-reactive protein (CRP) level
Units of measurement mg%
Daily measurement during 14 days
Serum ferritin level
Units of measurement mg%
Daily measurement during 14 days
Serum Interferon gamma-induced protein 10 (IP10) level
Units of measurement pg/ml
Daily measurement during 14 days
Serum IL-6 level
Units of measurement pg/ml
Daily measurement during 14 days
Serum TNF-related apoptosis-inducing ligand (TRAIL)
Units of measurement pg/ml
Daily measurement during 14 days
Secondary Outcomes (9)
Study drug related adverse events
14 days
Patient adherence to the study protocol
14 days
Ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2) ratio (PaO2/FiO2 ratio) for ventilated patients
14 days
Length of ventilation for ventilated patients
28 days
Length of stay in the ICU
28 days
- +4 more secondary outcomes
Study Arms (1)
CANNABIDIOL
EXPERIMENTALCANNABIDIOL 5% 3 ml twice daily for 14 days.
Interventions
Eligibility Criteria
You may qualify if:
- Laboratory-confirmed novel COVID-19 infection as determined by polymerase chain reaction, or other commercial or public health assay in oropharyngeal specimen within 72 hours prior to hospitalization.
- Patients with severe disease defined as individuals with pneumonia and one or more of the following criteria:
- Respiratory rate ≥ 30/min.
- Oxygen saturation at room air less than 93%.
- Patients with critical disease defined as individuals with respiratory failure requiring mechanical ventilation
- Age18 years and older
- Informed consent has to be obtained from all patients. The patient will sign the Informed Consent Form before entering the study.
- Some patients are expected to be unable to legally consent due to critical illness, and sedation. In case a legal guardian exists, approach for consent will be made.
You may not qualify if:
- Allergy to CBD
- Documented infection
- Pregnant and lactating women
- Predicted clinically that there is no hope of survival
- GI intolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rabin Medical Center
Petah Tikva, Israel
Related Publications (1)
Yeshurun M, Shpilberg O, Herscovici C, Shargian L, Dreyer J, Peck A, Israeli M, Levy-Assaraf M, Gruenewald T, Mechoulam R, Raanani P, Ram R. Cannabidiol for the Prevention of Graft-versus-Host-Disease after Allogeneic Hematopoietic Cell Transplantation: Results of a Phase II Study. Biol Blood Marrow Transplant. 2015 Oct;21(10):1770-5. doi: 10.1016/j.bbmt.2015.05.018. Epub 2015 May 30.
PMID: 26033282BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilya Kagan, MD
Rabin Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head BMT Unit
Study Record Dates
First Submitted
January 28, 2021
First Posted
January 29, 2021
Study Start
January 10, 2021
Primary Completion
December 31, 2021
Study Completion
April 30, 2022
Last Updated
January 29, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share