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NCT04731116

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

Status unknown Phase 1, PHASE2 Last updated 29 January 2021
What this trial tests

Phase 1, PHASE2 trial testing Cannabidiol in COVID-19 in 40 participants. Status unknown.

Timeline
10 January 2021
Primary endpoint
31 December 2021
30 April 2022

Quick facts

Lead sponsorRabin Medical Center
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment40
Start date10 January 2021
Primary completion31 December 2021
Estimated completion30 April 2022
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Rabin Medical Center

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions.
    Alam S, Sarker MMR, Afrin S, Richi FT, et al · · 2021 · cited 61× · PMID 34122096 · DOI 10.3389/fphar.2021.671498
  2. Cannabidiol inhibits SARS-Cov-2 spike (S) protein-induced cytotoxicity and inflammation through a PPARγ-dependent TLR4/NLRP3/Caspase-1 signaling suppression in Caco-2 cell line.
    Corpetti C, Del Re A, Seguella L, Palenca I, et al · · 2021 · cited 50× · PMID 34643000 · DOI 10.1002/ptr.7302
  3. <i>In silico</i> investigation and potential therapeutic approaches of natural products for COVID-19: Computer-aided drug design perspective.
    Rahman MM, Islam MR, Akash S, Mim SA, et al · · 2022 · cited 18× · PMID 36072227 · DOI 10.3389/fcimb.2022.929430
  4. Stroke in SARS-CoV-2 Infection: A Pictorial Overview of the Pathoetiology.
    Aghayari Sheikh Neshin S, Shahjouei S, Koza E, Friedenberg I, et al · · 2021 · cited 18× · PMID 33855053 · DOI 10.3389/fcvm.2021.649922
  5. In vitro evaluation of the impact of Covid-19 therapeutic agents on the hydrolysis of the antiviral prodrug remdesivir.
    Zhang Q, Melchert PW, Markowitz JS. · · 2022 · cited 10× · PMID 35964681 · DOI 10.1016/j.cbi.2022.110097
  6. Multifaceted roles of plant derived small molecule inhibitors on replication cycle of SARS-CoV-2.
    Uma Reddy B, Routhu NK, Kumar A. · · 2022 · cited 7× · PMID 35381324 · DOI 10.1016/j.micpath.2022.105512
  7. Rational drug repositioning for coronavirus-associated diseases using directional mapping and side-effect inference.
    Wang J, Liu J, Luo M, Cui H, et al · · 2022 · cited 5× · PMID 36267550 · DOI 10.1016/j.isci.2022.105348
  8. The immunology and immunotherapy for COVID-19.
    Liu Y, Zhou X, Liu X, Jiang X. · · 2021 · cited 3× · PMID 34915958 · DOI 10.1017/erm.2021.30

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