Humulus Lupus Extract Rich in Xanthohumol Improves Clinical Course in Critically Ill COVID-19 Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Xanthohumol reduces coronavirus-induced inflammatory response
研究概览
简要总结
It has been well documented that coronavirus COVID-19 disease is associated with massive inflammatory response and cytokine storm. Several medications have been used to ameliorate COVID-19-related inflammation. Xanthohumol, a natural medication extracted from hop cones, possesses strong anti-inflammatory properties and can reduce the severity of inflammatory response. The aim of this study is to analyze the effect of Xanthohumol on clinical course, inflammatory response and outcome in patients admitted to the ICU due to COVID-related acute respiratory failure with an oxygenation index (PaO2/FiO2) less than 150.
详细描述
Xanthohumol inhibits proinflammatory pathways in different independent mechanisms. Ir inhibits farnesoid X receptor activity, and reduces the synthesis and release of different proinflammatory cytokines such as IL-1β, IL-6, IL-8, IL-12p70, TNFα and interferon γ. The pathomechanism of its anti-inflammatory activity is associated with the suppression of nuclear factor-kappa B. Additionally, Xanthohumol inhibits inflammatory-induced endothelial disorders, which are associated with an improvement in blood velocity and a reduction in the risk of arterial thrombosis, especially in pulmonary arteries. An increase in proinflammatory release, known as cytokine storm, as well as increased incidences of vascular thrombosis, are observed in coronavirus infection. Hence, Xanthohumol may reduce the severity of the clinical course in COVID-19 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Clinical diagnosis of COVID-19 with acute respiratory failure (PaO2/FiO2 below 150).
排除标准
- •History of chronic cardiovascular, liver or/and kidney diseases. History of chronic pulmonary diseases with prolonged oxygen supplementation or domestic mechanical ventilation.
- •Pregnant women, Neoplastic diseases, Immunologic diseases Patients received immunomodulatory treatment.
结局指标
主要结局
Xanthohumol reduces coronavirus-induced inflammatory response
时间窗: one week after regular supplementation
Xanthohumol possesses strong anti-inflammatory properties. It can reduce the production and secretion of pro-inflammatory cytokines. Additionally, it inhibits inflammatory-induced endothelial dysregulation and exerting antiangiogenic and anti-inflammatory effects.
Xanthohumol improves clinical course in critically ill COVID-19 patients
时间窗: 28 days mortality
Reduction the severity of inflammatory response should affect clinical course. Strong anti-inflammatory treatment can reduce a risk of poor outcome.
次要结局
未报告次要终点
研究者
Wojciech Dąbrowski
Prof MD PhD, Head of Chair and First Department of Anaesthesiology and Intensive Therapy
Medical University of Lublin