Cannabidiol Treatment for Severe and Critical Coronavirus (COVID-19) Pulmonary Infection
|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: NCT04731116|
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : January 29, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Cannabidiol||Phase 1 Phase 2|
- Describe the impact of CBD on the cytokine profile in patients with severe and critical COVID-19 infection.
- Explore the safety and efficacy of CBD treatment in patients with severe and critical COVID-19 pulmonary Infection.
This is a single center, prospective open label phase 1/2-study which will be conducted in a Corona isolation ward.
Cannabidiol 5% dissolved in olive oil, will be given orally or through a nasogastric tube at a dose of 150 mg twice daily during 14 days or until discharge (the earliest). This dose is based on safety data generated from more than 100 transplanted patients. Treatment duration may be extended up to 28 days according to the physician discretion. In case of intolerance to the dose of 150 mg twice daily, the dose of CBD will be reduced to the maximal tolerated dose.
In the case of grade 4 side effects related to CBD or in the case of inability to provide the CBD during more the 3 days, the patient will be withdrawn from the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cannabidiol Treatment for Severe and Critical COVID-19 Pulmonary Infection|
|Actual Study Start Date :||January 10, 2021|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||April 30, 2022|
CANNABIDIOL 5% 3 ml twice daily for 14 days.
Oral Cannabidiol 150 mg twice daily during 14 days
- Serum C-reactive protein (CRP) level [ Time Frame: Daily measurement during 14 days ]Units of measurement mg%
- Serum ferritin level [ Time Frame: Daily measurement during 14 days ]Units of measurement mg%
- Serum Interferon gamma-induced protein 10 (IP10) level [ Time Frame: Daily measurement during 14 days ]Units of measurement pg/ml
- Serum IL-6 level [ Time Frame: Daily measurement during 14 days ]Units of measurement pg/ml
- Serum TNF-related apoptosis-inducing ligand (TRAIL) [ Time Frame: Daily measurement during 14 days ]Units of measurement pg/ml
- Study drug related adverse events [ Time Frame: 14 days ]Number of participants with grade 3-4 study drug-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 during treatment.
- Patient adherence to the study protocol [ Time Frame: 14 days ]Number of cannabidiol doses actually taken by the patient divided by 28 (number of planned doses)
- Ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2) ratio (PaO2/FiO2 ratio) for ventilated patients [ Time Frame: 14 days ]Daily measurement of ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2) ratio (PaO2/FiO2 ratio) for ventilated patients
- Length of ventilation for ventilated patients [ Time Frame: 28 days ]Number of days patient in need of mechanical ventilation
- Length of stay in the ICU [ Time Frame: 28 days ]Number of days the patient stays in ICU
- Survival by day 28 [ Time Frame: 28 days ]Patient alive (yes/no) on day 28
- Remission of respiratory symptoms [ Time Frame: 28 days ]Patient without dyspnea and saturation above 93% at room air.
- Documented infections up to discharge [ Time Frame: 28 days ]Any documented infection in addition to COVID
- Sequential organ failure assistance (SOFA) score [ Time Frame: 28 days ]Sequential organ failure assistance score calculation:range 0 to 24. A higher score is associated with higher risk of ICU mortality.
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): NCT04731116
|Contact: Ilya Kagan, MD||972-50-4065483||Ilyak@clalit.org.il|
|Contact: Moshe Yeshurun, MDemail@example.com|
|Principal Investigator:||Ilya Kagan, MD||Rabin Medical Center|