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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recipients of CBD oil | Experimental | 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. |
|
| Recipients of Placebo | Placebo Comparator | Patients receiving placebo oil, administered sublingual, 3 times a day, while hospitalized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD | Drug | CBD oil not containing THC, to be administered sub-lingual. |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Howard Amital, MD, MHA | Contact | +972-3-5302638 | Howard.Amital@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Howard Amital, MD, MHA | Head of Internal Medicine ward "B", Sheba Health Center, Tel Hashomer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center, Tel Hashomer | Recruiting | Ramat Gan | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo |
| Drug |
Placebo Oil |
|
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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |