Synthetic CBD as a Therapy for COVID-19
Synthetic CBD Oil Droplets as a Therapy for Mild to Moderate SARS-CoV-2 Infection. Assesment of Efficacy and Safety.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 covid19
Started Jan 2021
Typical duration for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2020
CompletedFirst Posted
Study publicly available on registry
December 28, 2020
CompletedStudy Start
First participant enrolled
January 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedSeptember 28, 2021
September 1, 2021
10 months
December 18, 2020
September 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Changes in NEWS scale
14 days
Supportive care therapies
14 days
SARS-COV2 presence
10 days, 14 days
Hospitalization Days
14 days
Cytokine Levels
Day 3, day 7, discharge day (which is on average the 10th day of hospitalization).
- +1 more secondary outcomes
Study Arms (2)
Recipients of CBD oil
EXPERIMENTALPatients 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 COMPARATORPatients receiving placebo oil, administered sublingual, 3 times a day, while hospitalized.
Interventions
Eligibility Criteria
You may qualify if:
- COVID 19 patients
- Years and older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center, Tel Hashomer
Ramat Gan, Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard Amital, MD, MHA
Head of Internal Medicine ward "B", Sheba Health Center, Tel Hashomer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Autoimmune Center, Head of internal medicine ward "B", Sheba Medical Center
Study Record Dates
First Submitted
December 18, 2020
First Posted
December 28, 2020
Study Start
January 20, 2021
Primary Completion
November 1, 2021
Study Completion
January 1, 2022
Last Updated
September 28, 2021
Record last verified: 2021-09