Cannabidiol Treatment for Severe and Critical COVID-19 Pulmonary Infection
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Serum IL-6 level
研究概览
简要总结
Current management of COVID-19 (coronavirus) is mainly supportive, and respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of mortality. Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with severe acute respiratory syndrome (SARS).
Cannabidiol (CBD), a nonpsychotropic ingredient of Cannabis sativa, possesses potent anti-inflammatory and immunosuppressive properties. These effects are mediated by T cell attrition and by inhibition of pro-inflammatory cytokine release (tumor necrosis factor-a, Interferon gamma, IL-1b, IL-6, and IL-17) and stimulation of anti-inflammatory cytokine production (IL-4, IL-5, IL-10, and IL-13). In a number of phase 2 trials involving more than 100 patients, our group was able to show the safety and efficacy of CBD in the prevention and treatment of graft-versus-host disease.
Based on these data, we will test the cytokine profile, safety and efficacy of CBD treatment in patients with severe and critical COVID-19 infection.
详细描述
Study objectives:
- Describe the impact of CBD on the cytokine profile in patients with severe and critical COVID-19 infection.
- Explore the safety and efficacy of CBD treatment in patients with severe and critical COVID-19 pulmonary Infection.
Methods:
This is a single center, prospective open label phase 1/2-study which will be conducted in a Corona isolation ward.
Investigational therapy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Laboratory-confirmed novel COVID-19 infection as determined by polymerase chain reaction, or other commercial or public health assay in oropharyngeal specimen within 72 hours prior to hospitalization.
- •Patients with severe disease defined as individuals with pneumonia and one or more of the following criteria:
- •Respiratory rate ≥ 30/min.
- •Oxygen saturation at room air less than 93%.
- •Patients with critical disease defined as individuals with respiratory failure requiring mechanical ventilation
- •Age18 years and older
- •Informed consent has to be obtained from all patients. The patient will sign the Informed Consent Form before entering the study.
- •Some patients are expected to be unable to legally consent due to critical illness, and sedation. In case a legal guardian exists, approach for consent will be made.
排除标准
- •Allergy to CBD
- •Documented infection
- •Pregnant and lactating women
- •Predicted clinically that there is no hope of survival
- •GI intolerance
研究组 & 干预措施
CANNABIDIOL
CANNABIDIOL 5% 3 ml twice daily for 14 days.
干预措施: Cannabidiol (Drug)
结局指标
主要结局
Serum IL-6 level
时间窗: Daily measurement during 14 days
Units of measurement pg/ml
Serum ferritin level
时间窗: Daily measurement during 14 days
Units of measurement mg%
Serum C-reactive protein (CRP) level
时间窗: Daily measurement during 14 days
Units of measurement mg%
Serum Interferon gamma-induced protein 10 (IP10) level
时间窗: Daily measurement during 14 days
Units of measurement pg/ml
Serum TNF-related apoptosis-inducing ligand (TRAIL)
时间窗: Daily measurement during 14 days
Units of measurement pg/ml
次要结局
- Length of stay in the ICU(28 days)
- Length of ventilation for ventilated patients(28 days)
- Study drug related adverse events(14 days)
- Patient adherence to the study protocol(14 days)
- Ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2) ratio (PaO2/FiO2 ratio) for ventilated patients(14 days)
- Remission of respiratory symptoms(28 days)
- Documented infections up to discharge(28 days)
- Sequential organ failure assistance (SOFA) score(28 days)
- Survival by day 28(28 days)
研究者
moshe yeshurun
Head BMT Unit
Rabin Medical Center