CBD, Covid19
Conditions
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.
Interventions
DRUGPlacebo
Placebo Oil
DRUGCBD
CBD oil not containing THC, to be administered sub-lingual.
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Hamilton Anxiety Score | 14 days | A verified score measuring anxiety. Minimum score is 0, while maximum score is 56. Higher scores mean worse outcome. |
| Hospitalization Days | 14 days | Hospitalization days due to COVID-19 |
Countries
Israel
Contacts
Primary ContactHoward Amital, MD, MHA
Outcome results
None listed