Synthetic CBD as a Therapy for COVID-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04686539
• Other study ID #: SHEBA-20-7526-HA-CTIL
• Status: Recruiting
• Phase: Phase 1
• Start date: January 20, 2021
• Est. completion date: January 2022

Study information

• Verified date: September 2021
• Source: Sheba Medical Center
• Contact: Howard Amital, MD, MHA
• Phone: +972-3-5302638
• Email: Howard.Amital[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CBD
• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Israel	Sheba Medical Center, Tel Hashomer	Ramat Gan	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	SARS-COV2 presence	Presence of SARS-COV2 in oral & nasal secretions in days 10, 14 of the study	10 days, 14 days
Secondary	Hospitalization Days	Hospitalization days due to COVID-19	14 days
Secondary	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).
Secondary	Hamilton Anxiety Score	A verified score measuring anxiety. Minimum score is 0, while maximum score is 56. Higher scores mean worse outcome.	14 days