Synthetic CBD as a Therapy for COVID-19
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.
Arms and Interventions
|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.
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.
Primary Outcome Measures
- 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
- 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
- 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.
- SARS-COV2 presence [10 days, 14 days]
Presence of SARS-COV2 in oral & nasal secretions in days 10, 14 of the study
- Hospitalization Days [14 days]
Hospitalization days due to COVID-19
- 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.
- Hamilton Anxiety Score [14 days]
A verified score measuring anxiety. Minimum score is 0, while maximum score is 56. Higher scores mean worse outcome.
COVID 19 patients
18 Years and older
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.
Hemodialysis renal replacement therapy
Active or prior psychotic event
Contacts and Locations
|1||Sheba Medical Center, Tel Hashomer||Ramat Gan||Tel Aviv||Israel|
Sponsors and Collaborators
- Sheba Medical Center
- Principal Investigator: Howard Amital, MD, MHA, Head of Internal Medicine ward "B", Sheba Health Center, Tel Hashomer
Study Documents (Full-Text)None provided.