The Efficacy and Safety of Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of Novel Coronavirus Pneumonia Patient (COVID-19) : An Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1
研究概览
简要总结
There is still no effective antiviral drugs and vaccines against SARS-CoV-2 yet now. This is an obsevational study, the investigators collected the clinical information and clinical outcomes of the COVID-19 patients using anti-2019-nCoV inactivated convalescent plasma.The study is to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of COVID-19 pneumonia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants were diagnosed as COVID-19;
- •Participants received anti-SARS-CoV-2 inactivated convalescent plasma
- •Written the informed consent.
排除标准
- •Participants lacked detailed medical history
结局指标
主要结局
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1
时间窗: 1 day after receiving plasma transmission
The SARS-CoV-2 nuclei acid was quantified using RT-PCR
Numbers of participants with different Clinical outcomes
时间窗: From receiving plasma transmission to 4 weeks
Clinical outcomes include death, critical illness, recovery
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3
时间窗: 3 days after receiving plasma transmission
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7
时间窗: 7 days after receiving plasma transmission
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(4 weeks after receiving plasma transmission)
研究者
Hongzhou Lu
professor
Shanghai Public Health Clinical Center