Synthetic CBD as a Therapy for COVID-19

Sheba Medical Center

Status and phase: Unknown; Phase 1

Conditions: Covid19; CBD

Treatments: Drug: CBD; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04686539

SHEBA-20-7526-HA-CTIL

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Recipients of CBD oil

Experimental group

Description:

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.

Treatment:

Drug: CBD

Recipients of Placebo

Placebo Comparator group

Description:

Patients receiving placebo oil, administered sublingual, 3 times a day, while hospitalized.

Treatment:

Drug: Placebo