Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The change of pneumonia severity on X-ray images
研究概览
简要总结
Although immune-inflammatory treatment is not routinely recommended to be used for SARS-CoV-2 pneumonia, according to the pathological findings of pulmonary oedema and hyaline membrane formation, timely and appropriate use of immune modulator together with ventilator support should be considered for the severe patients to prevent ARDS development. The sphingosine-1-phosphate receptor regulators Fingolimod (FTY720) is an effective immunology modulator which has been widely used in multiple sclerosis.The aim of this study was to determine whether the efficacy of fingolimod for a novel coronavirus disease (COVID-19).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who were diagnosed with the common type of NCP (including severe risk factors) and severe cases of new coronavirus pneumonia;
- •Aged 18 to 85 years;
- •Patients or authorized family members volunteered to participate in this study and signed informed consent.
排除标准
- •Patients with any history of bradyarrhythmia or atrioventricular blocks
- •Patients who are participating in other drug clinical trials;
- •Pregnant or lactating women;
- •ALT / AST> 5 ULN, neutrophils <0.5, platelets less than 50;
- •Definite diagnosis of rheumatic immune-related diseases;
- •Long-term oral anti-rejection or immunomodulatory drugs;
- •Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections.
研究组 & 干预措施
Treatment group
干预措施: Fingolimod 0.5 mg (Drug)
结局指标
主要结局
The change of pneumonia severity on X-ray images
时间窗: 5 day after fingolimod treatment
The lesion change on X-ray images from day 5 to baseline
次要结局
未报告次要终点
研究者
Ning Wang, MD., PhD.
Doctor
First Affiliated Hospital of Fujian Medical University