Synthetic CBD Oil Droplets as a Therapy for Mild to Moderate SARS-CoV-2 Infection. Assesment of Efficacy and Safety.
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical deterioration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID 19 patients
- •18 Years and older
排除标准
- •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
研究组 & 干预措施
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.
干预措施: CBD (Drug)
Recipients of Placebo
Patients receiving placebo oil, administered sublingual, 3 times a day, while hospitalized.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical deterioration
时间窗: 14 days
Patients chance of clinical deterioration of COVID19 disease as defined by percentage of patients requiring oxygen therapy during their hospitalization.
次要结局
- Supportive care therapies(14 days)
- Changes in NEWS scale(14 days)
- Hospitalization Days(14 days)
- Cytokine Levels(Day 3, day 7, discharge day (which is on average the 10th day of hospitalization).)
- SARS-COV2 presence(10 days, 14 days)
- Hamilton Anxiety Score(14 days)
研究者
Prof. Howard Amital
Head of Autoimmune Center, Head of internal medicine ward "B", Sheba Medical Center
Sheba Medical Center