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Synthetic CBD as a Therapy for COVID-19

Primary Purpose

Covid19, CBD

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
CBD
Placebo
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sheba Medical Center, Tel HashomerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Recipients of CBD oil

Recipients of Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in NEWS scale
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
Supportive care therapies
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.
SARS-COV2 presence
Presence of SARS-COV2 in oral & nasal secretions in days 10, 14 of the study
Hospitalization Days
Hospitalization days due to COVID-19
Cytokine Levels
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.
Hamilton Anxiety Score
A verified score measuring anxiety. Minimum score is 0, while maximum score is 56. Higher scores mean worse outcome.

Full Information

First Posted
December 18, 2020
Last Updated
September 26, 2021
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04686539
Brief Title
Synthetic CBD as a Therapy for COVID-19
Official Title
Synthetic CBD Oil Droplets as a Therapy for Mild to Moderate SARS-CoV-2 Infection. Assesment of Efficacy and Safety.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, CBD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recipients of CBD oil
Arm Type
Experimental
Arm Description
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.
Arm Title
Recipients of Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receiving placebo oil, administered sublingual, 3 times a day, while hospitalized.
Intervention Type
Drug
Intervention Name(s)
CBD
Intervention Description
CBD oil not containing THC, to be administered sub-lingual.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Oil
Primary Outcome Measure Information:
Title
Clinical deterioration
Description
Patients chance of clinical deterioration of COVID19 disease as defined by percentage of patients requiring oxygen therapy during their hospitalization.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Changes in NEWS scale
Description
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
Time Frame
14 days
Title
Supportive care therapies
Description
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.
Time Frame
14 days
Title
SARS-COV2 presence
Description
Presence of SARS-COV2 in oral & nasal secretions in days 10, 14 of the study
Time Frame
10 days, 14 days
Title
Hospitalization Days
Description
Hospitalization days due to COVID-19
Time Frame
14 days
Title
Cytokine Levels
Description
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.
Time Frame
Day 3, day 7, discharge day (which is on average the 10th day of hospitalization).
Title
Hamilton Anxiety Score
Description
A verified score measuring anxiety. Minimum score is 0, while maximum score is 56. Higher scores mean worse outcome.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Howard Amital, MD, MHA
Phone
+972-3-5302638
Email
Howard.Amital@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Amital, MD, MHA
Organizational Affiliation
Head of Internal Medicine ward "B", Sheba Health Center, Tel Hashomer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center, Tel Hashomer
City
Ramat Gan
State/Province
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard Amital, MD, MHA
Phone
+972-3-5302638
Email
Howard.amital@sheba.health.gov.il

12. IPD Sharing Statement

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Synthetic CBD as a Therapy for COVID-19

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