Synthetic CBD as a Therapy for COVID-19

Sponsor
Sheba Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04686539
Collaborator
(none)
50
1
2
11.4
4.4

Study Details

Study Description

Brief Summary

The study aim to test proof of concept of CBD treatment for efficacy and safety in patients suffering with mild COVID-19 infection. The CBD will be delivered via oil droplets not containing THC, compared to placebo.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Synthetic CBD Oil Droplets as a Therapy for Mild to Moderate SARS-CoV-2 Infection. Assesment of Efficacy and Safety.
Actual Study Start Date :
Jan 20, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Recipients of CBD oil

Patients receiving Cannabidiol oil drops, administered sublingual, 3 times a day, while hospitalized. Dosing and administration frequency would be assessed bi-daily by the medical staff.

Drug: CBD
CBD oil not containing THC, to be administered sub-lingual.

Placebo Comparator: Recipients of Placebo

Patients receiving placebo oil, administered sublingual, 3 times a day, while hospitalized.

Drug: Placebo
Placebo Oil

Outcome Measures

Primary Outcome Measures

  1. Clinical deterioration [14 days]

    Patients chance of clinical deterioration of COVID19 disease as defined by percentage of patients requiring oxygen therapy during their hospitalization.

Secondary Outcome Measures

  1. Changes in NEWS scale [14 days]

    NEWS2- National Early Warning Score - a score defining the probability of severe COVID 19 disease. Minimum score is 0, while maximum score is 23. Higher score means worse outcome

  2. Supportive care therapies [14 days]

    Percentage of patients requiring the respiratory support of either of the following : high flow nasal canula oxygen support, mechanical ventilation or use of extra corporeal membrane oxygenation.

  3. SARS-COV2 presence [10 days, 14 days]

    Presence of SARS-COV2 in oral & nasal secretions in days 10, 14 of the study

  4. Hospitalization Days [14 days]

    Hospitalization days due to COVID-19

  5. Cytokine Levels [Day 3, day 7, discharge day (which is on average the 10th day of hospitalization).]

    IL2, IL18, IL8. IL6, IL10, TNF-alpha, TGF-beta levels at day 3, day 7 and discharge day (which is on average the 10th day of hospitalization). All cytokine levels would be measured by pg/mL.

  6. Hamilton Anxiety Score [14 days]

    A verified score measuring anxiety. Minimum score is 0, while maximum score is 56. Higher scores mean worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • COVID 19 patients

  • 18 Years and older

Exclusion Criteria:
  • Respiratory failure requiring mechanical ventilation

  • Intensive care unit admission

  • Neutrophile con. < 1000 cells/mm3

  • Lymphocyte con < 500 cells/mm3

  • Liver enzymes 5 times higher then the norm

  • QT interval longer then 500 ms.

  • Pregnancy

  • Hemodialysis renal replacement therapy

  • Active or prior psychotic event

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sheba Medical Center, Tel Hashomer Ramat Gan Tel Aviv Israel

Sponsors and Collaborators

  • Sheba Medical Center

Investigators

  • Principal Investigator: Howard Amital, MD, MHA, Head of Internal Medicine ward "B", Sheba Health Center, Tel Hashomer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Howard Amital, Head of Autoimmune Center, Head of internal medicine ward "B", Sheba Medical Center, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT04686539
Other Study ID Numbers:
  • SHEBA-20-7526-HA-CTIL
First Posted:
Dec 28, 2020
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021