Synthetic CBD as a Therapy for COVID-19

Study Overview
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Brief Summary
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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.

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

Conditions
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CBD, Covid19

Intervention / Treatment
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* Drug: CBD
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recipients of CBD oil<br>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<br>* CBD oil not containing THC, to be administered sub-lingual.<br>|
| Placebo Comparator: Recipients of Placebo<br>Patients receiving placebo oil, administered sublingual, 3 times a day, while hospitalized. | Drug: Placebo<br>* Placebo Oil<br>|

What is the study measuring?
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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 |