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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04686539
Other study ID # SHEBA-20-7526-HA-CTIL
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 20, 2021
Est. completion date January 2022

Study information

Verified date September 2021
Source Sheba Medical Center
Contact Howard Amital, MD, MHA
Phone +972-3-5302638
Email Howard.Amital@sheba.health.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 2022
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CBD
CBD oil not containing THC, to be administered sub-lingual.
Placebo
Placebo Oil

Locations

Country Name City State
Israel Sheba Medical Center, Tel Hashomer Ramat Gan Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary SARS-COV2 presence Presence of SARS-COV2 in oral & nasal secretions in days 10, 14 of the study 10 days, 14 days
Secondary Hospitalization Days Hospitalization days due to COVID-19 14 days
Secondary 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).
Secondary Hamilton Anxiety Score A verified score measuring anxiety. Minimum score is 0, while maximum score is 56. Higher scores mean worse outcome. 14 days
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