Synthetic CBD as a Therapy for COVID-19

Synthetic CBD Oil Droplets as a Therapy for Mild to Moderate SARS-CoV-2 Infection. Assesment of Efficacy and Safety.

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; CBD
• Intervention / Treatment: Drug: CBD; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Howard Amital, MD, MHA; Phone Number: +972-3-5302638; Email: Howard.amital@sheba.health.gov.il

Study Locations

• Israel
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel
      • Recruiting
      • Sheba Medical Center, Tel Hashomer
      • Contact: Howard Amital, MD, MHA; Phone Number: +972-3-5302638; Email: Howard.amital@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical deterioration	Patients chance of clinical deterioration of COVID19 disease as defined by percentage of patients requiring oxygen therapy during their hospitalization.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	14 days
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.	14 days
SARS-COV2 presence	Presence of SARS-COV2 in oral & nasal secretions in days 10, 14 of the study	10 days, 14 days
Hospitalization Days	Hospitalization days due to COVID-19	14 days
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.	Day 3, day 7, discharge day (which is on average the 10th day of hospitalization).
Hamilton Anxiety Score	A verified score measuring anxiety. Minimum score is 0, while maximum score is 56. Higher scores mean worse outcome.	14 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SHEBA-20-7526-HA-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No