Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0
研究概览
简要总结
Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged at 18 years-65 years old
- •Pneumonia that is judged by chest radiograph or computed tomography
- •Laboratory confirmation of NCP infection by reverse-transcription polymerase chain reaction(RT-PCR) from any diagnostic sampling source
排除标准
- •Pregnancy or breastfeeding
- •Known HIV, HBV or HCV infection
- •Patients with malignant tumor, other serious systemic diseases and psychosis
- •Patients who are participating in other clinical trials
- •Inability to provide informed consent or to comply with test requirements
结局指标
主要结局
Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0
时间窗: Measured from day 0 through day 28
Safety evaluation
Improvement of clinical symptoms including duration of fever
时间窗: Measured from day 0 through day 28
Evaluation of pneumonia improvement
Improvement of clinical symptoms including respiratory frequency
时间窗: Measured from day 0 through day 28
Evaluation of pneumonia improvement
次要结局
- CD4+ and CD8+ T cell count(Measured from day 0 through day 28)
- Time of virus nucleic acid test negative(Measured from day 0 through day 28)
- Rate of mortality within 28-days(Day 28)
- Size of lesion area by thoracic imaging(Measured from day 0 through day 28)