Cannabidiol Treatment for Severe and Critical Coronavirus (COVID-19) Pulmonary Infection

NCT ID: NCT04731116

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-10
• Study Completion Date: 2022-04-30

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.

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.

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CANNABIDIOL

CANNABIDIOL 5% 3 ml twice daily for 14 days.

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

Oral Cannabidiol 150 mg twice daily during 14 days

Interventions

Cannabidiol

Oral Cannabidiol 150 mg twice daily during 14 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

moshe yeshurun

Head BMT Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilya Kagan, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rabin Medical Center

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ilya Kagan, MD

Role: CONTACT

Phone: 972-50-4065483

Email: Ilyak@clalit.org.il

Moshe Yeshurun, MD

Role: CONTACT

Phone: 972-52-6015543

Email: moshey@clalit.org.il

Facility Contacts

Ilya Kagan, MD

Role: primary

Moshe Yeshurun, MD

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 26033282 (View on PubMed)

Other Identifiers

0245-20-RMC

Identifier Type: -

Identifier Source: org_study_id