Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Recovery of Pneumonia
研究概览
简要总结
In December 2019, a new virus emerged in Wuhan, China rapidly becoming a pandemic with registered cases above 800,000 around the world. The virus is now known as SARS-CoV2 calling its disease coronavirus-19 or COVID-19. The mortality of the virus has been reported around 2-10% and its causes because of the proinflammatory immune response generated on the host. The cytokines involved in the immune response to COVID-19 are IL-1, IL-2, IL4, IL-6, IL-10, IL-12, IL-13, IL-17, GCSF, MCSF, IP-10, MCP-1, MIP-1α, HGF, IFN-γ y TNF-α.
Ruxolitinib is an inhibitor of JAK 1/2 which is responsable for multiple cellular signals including the proinflammatory IL-6. Ruxolitinib works as and immunomodulator decreasing the cytotoxic T lymphocytes and increasing the Treg cells.
This study is intended to stop the disregulated immune response caused by COVID-19 that generates the pneumonia and subsequent severe acute respiratory syndrome.
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
- •Patients with diagnosed COVID-19 with confirmatory test
- •Increase in work of breathing or presence of dyspnea
- •Presence of lung changes associated with COVID pneumonia by chest imaging
- •Informed consent
排除标准
- •Pregnancy or breastfeeding
- •Thrombocytopenia below 20,000 cells/mm3
- •Neutropenia below 500 cels/mm3
- •Known and active infection of HIV, Hepatitis C, Hepatitis B, Herpes Zoster or Mycobacterium Tuberculosis
研究组 & 干预措施
Ruxolitinib
Ruxolitinib 5 mg BID since the beginning of dyspnea or increment of work of breathing with pneumonia changes in chest CT-scan
干预措施: Ruxolitinib Oral Tablet (Drug)
结局指标
主要结局
Recovery of Pneumonia
时间窗: 14 days
Presence of recovery of pneumonia characterized by cease of respiratory symptoms
次要结局
- Response of C-reactive protein(14 days)
- Response of Ferritin(14 days)
- Toxicity Rate(1 month)
- Response of D-dimer(14 days)
- Rate of ICU admission(14 days)
- Rate of mechanical ventilation(14 days)
- Overall Survival(1 month)