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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
Sponsor:
Information provided by (Responsible Party):
Prof. Howard Amital, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Covid19 CBD Drug: CBD Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: CBD
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.
Drug: Placebo
Placebo Oil




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. SARS-COV2 presence [ Time Frame: 10 days, 14 days ]
    Presence of SARS-COV2 in oral & nasal secretions in days 10, 14 of the study

  4. Hospitalization Days [ Time Frame: 14 days ]
    Hospitalization days due to COVID-19

  5. 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.


  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Howard Amital, MD, MHA +972-3-5302638 Howard.Amital@sheba.health.gov.il

Locations
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Israel
Sheba Medical Center, Tel Hashomer Recruiting
Ramat Gan, Tel Aviv, Israel
Contact: Howard Amital, MD, MHA    +972-3-5302638    Howard.amital@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Howard Amital, MD, MHA Head of Internal Medicine ward "B", Sheba Health Center, Tel Hashomer
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Responsible Party: Prof. Howard Amital, Head of Autoimmune Center, Head of internal medicine ward "B", Sheba Medical Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04686539    
Other Study ID Numbers: SHEBA-20-7526-HA-CTIL
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases