Synthetic CBD as a Therapy for COVID-19

Phase 1

• Conditions: Covid19; CBD
• Interventions: Drug: Placebo; Drug: CBD

• Registration Number: NCT04686539
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-28
• Study Start: 2021-01-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-26
• Last Update Posted: 2021-09-28
• Primary Completion: 2021-11
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• COVID 19 patients
• 18 Years and older

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recipients of Placebo	Placebo	Patients receiving placebo oil, administered sublingual, 3 times a day, while hospitalized.
Recipients of CBD oil	CBD	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Hospitalization Days	14 days	Hospitalization days due to COVID-19
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.
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
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.
SARS-COV2 presence	10 days, 14 days	Presence of SARS-COV2 in oral \& nasal secretions in days 10, 14 of the study
Hamilton Anxiety Score	14 days	A verified score measuring anxiety. Minimum score is 0, while maximum score is 56. Higher scores mean worse outcome.

Trial Locations

Locations (1)

Sheba Medical Center, Tel Hashomer; 🇮🇱 Ramat Gan, Tel Aviv, Israel