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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
Sponsor:
Information provided by (Responsible Party):
moshe yeshurun, Rabin Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Cannabidiol Phase 1 Phase 2

Detailed Description:

Study objectives:

  1. Describe the impact of CBD on the cytokine profile in patients with severe and critical COVID-19 infection.
  2. Explore the safety and efficacy of CBD treatment in patients with severe and critical COVID-19 pulmonary Infection.

Methods:

This is a single center, prospective open label phase 1/2-study which will be conducted in a Corona isolation ward.

Investigational therapy:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Experimental: CANNABIDIOL
CANNABIDIOL 5% 3 ml twice daily for 14 days.
 Drug: Cannabidiol
Oral Cannabidiol 150 mg twice daily during 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Serum C-reactive protein (CRP) level [ Time Frame: Daily measurement during 14 days ]
    Units of measurement mg%

  2. Serum ferritin level [ Time Frame: Daily measurement during 14 days ]
    Units of measurement mg%

  3. Serum Interferon gamma-induced protein 10 (IP10) level [ Time Frame: Daily measurement during 14 days ]
    Units of measurement pg/ml

  4. Serum IL-6 level [ Time Frame: Daily measurement during 14 days ]
    Units of measurement pg/ml

  5. Serum TNF-related apoptosis-inducing ligand (TRAIL) [ Time Frame: Daily measurement during 14 days ]
    Units of measurement pg/ml


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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

  4. Length of ventilation for ventilated patients [ Time Frame: 28 days ]
    Number of days patient in need of mechanical ventilation

  5. Length of stay in the ICU [ Time Frame: 28 days ]
    Number of days the patient stays in ICU

  6. Survival by day 28 [ Time Frame: 28 days ]
    Patient alive (yes/no) on day 28

  7. Remission of respiratory symptoms [ Time Frame: 28 days ]
    Patient without dyspnea and saturation above 93% at room air.

  8. Documented infections up to discharge [ Time Frame: 28 days ]
    Any documented infection in addition to COVID

  9. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Respiratory rate ≥ 30/min.
    2. 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.

Exclusion Criteria:

  • Allergy to CBD
  • Documented infection
  • Pregnant and lactating women
  • Predicted clinically that there is no hope of survival
  • GI intolerance
Contacts and Locations
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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): NCT04731116


Contacts
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Contact: Ilya Kagan, MD 972-50-4065483 Ilyak@clalit.org.il
Contact: Moshe Yeshurun, MD 972-52-6015543 moshey@clalit.org.il

Locations
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Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel
Contact: Ilya Kagan, MD    972-50-4065483    Ilyak@clalit.org.il   
Contact: Moshe Yeshurun, MD       moshey@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Ilya Kagan, MD Rabin Medical Center
More Information
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Publications:

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Responsible Party: moshe yeshurun, Head BMT Unit, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT04731116    
Other Study ID Numbers: 0245-20-RMC
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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