NCT04731116

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

Cannabidiol Treatment for Severe and Critical COVID-19 Pulmonary Infection

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Cannabidiol	Oral Cannabidiol 150 mg twice daily during 14 days

Timeline

• Start date: 2021-01-10
• Primary completion: 2021-12-31
• Completion: 2022-04-30
• First posted: 2021-01-29
• Last updated: 2021-01-29

Locations

1 site across 1 country: Israel