Synthetic CBD as a Therapy for COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04686539|
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : September 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 CBD||Drug: CBD Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Synthetic CBD Oil Droplets as a Therapy for Mild to Moderate SARS-CoV-2 Infection. Assesment of Efficacy and Safety.|
|Actual Study Start Date :||January 20, 2021|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||January 2022|
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.
- Clinical deterioration [ Time Frame: 14 days ]Patients chance of clinical deterioration of COVID19 disease as defined by percentage of patients requiring oxygen therapy during their hospitalization.
- Changes in NEWS scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 10 days, 14 days ]Presence of SARS-COV2 in oral & nasal secretions in days 10, 14 of the study
- Hospitalization Days [ Time Frame: 14 days ]Hospitalization days due to COVID-19
- Cytokine Levels [ Time Frame: 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 [ Time Frame: 14 days ]A verified score measuring anxiety. Minimum score is 0, while maximum score is 56. Higher scores mean worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686539
|Contact: Howard Amital, MD, MHA||+972-3-5302638||Howard.Amital@sheba.health.gov.il|
|Sheba Medical Center, Tel Hashomer||Recruiting|
|Ramat Gan, Tel Aviv, Israel|
|Contact: Howard Amital, MD, MHA +972-3-5302638 Howard.firstname.lastname@example.org|
|Principal Investigator:||Howard Amital, MD, MHA||Head of Internal Medicine ward "B", Sheba Health Center, Tel Hashomer|