Synthetic CBD as a Therapy for COVID-19

Sheba Medical Center (Other)
Overall Status
Recruiting ID

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:
Anticipated Enrollment :
50 participants
Intervention Model:
Parallel Assignment
Double (Participant, Care Provider)
Primary Purpose:
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


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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


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

Sponsors and Collaborators

  • Sheba Medical Center


  • 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


None provided.
Responsible Party:
Prof. Howard Amital, Head of Autoimmune Center, Head of internal medicine ward "B", Sheba Medical Center, Sheba Medical Center Identifier:
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:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021