Retrospective Cohort to Evaluate the Effectiveness and Safety of Xiyanping Injection Combined With Conventional Treatment for New Coronavirus Infection Pneumonia (Common Type)
试验速览
- 阶段
- 不适用
- 入组人数
- 426
- 主要终点
- Clinical recovery time
研究概览
简要总结
the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laboratory examination (RT-PCR) confirms the infection 2019-nCoV, which meets the diagnostic criteria for pneumonia (common type) in the New Coronavirus Infection Pneumonia Diagnosis and Treatment Program (Trial Version 6);
- •The patient has a complete hospitalization record that can be used for research.
排除标准
- •Subjects who meet any of the following criteria cannot be enrolled:
- •Suffering from diseases that need to be distinguished from pneumonia infected with new coronavirus, such as tuberculosis, bacterial or viral pneumonia other than new coronavirus pneumonia, hospital-acquired pneumonia, and other pathogenic microorganisms pneumonia;
- •People with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformations, abnormal lung development, aspiration pneumonia, and lung malignant tumors;
- •According to the judgment of the investigator, the previous or current disease may affect the patient's participation in the trial or the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; presently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc;
- •Pneumonia diagnosed with severe, critically re-associated coronavirus infection or requiring mechanical ventilation or systemic anti-hormonal therapy;
- •Used Chinese patent medicines with similar efficacy as Xiyanping injection during the treatment.
- •The investigator judges that the relevant test or data is missing during the treatment process, which affects the research evaluation or analyst.
研究组 & 干预措施
Xiyanping injection +other drugs
Drug: Xiyanping injection Xiyanping injection: 10-20ml daily, Qd, the maximum daily dose does not exceed 500mg (20mL) Other drugs: Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride
干预措施: Xiyanping injection (Drug)
Xiyanping injection +other drugs
Drug: Xiyanping injection Xiyanping injection: 10-20ml daily, Qd, the maximum daily dose does not exceed 500mg (20mL) Other drugs: Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride
干预措施: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride (Drug)
other drugs
Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride
干预措施: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride (Drug)
结局指标
主要结局
Clinical recovery time
时间窗: Up to Day 14
From the beginning of study drug use to fever, respiratory rate, blood oxygen saturation to normal and cough relief, and maintained for at least 72 hours or more, calculated in hours
次要结局
- Cough relief time(Up to Day 14)
- Virus negative time(Up to Day 14)
- Complete fever time(Up to Day 14)
- Incidence of severe or critical neocoronavirus pneumonia(Up to Day 14)