An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Three Antiviral Drugs(Abidol Hydrochloride, Oseltamivir and Lopinavir/Ritonavir) in the Treatment of 2019-nCoV Pneumonia.
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Rate of disease remission
研究概览
简要总结
At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of three antiviral drugs in the treatment of 2019-nCoV pneumonia by studying the efficacy of abidol hydrochloride, oseltamivir and lopinavir/ritonavir in the treatment of 2019-nCoV viral pneumonia, and to explore effective antiviral drugs for new coronavirus. To provide reliable evidence-based medicine basis for the treatment of viral pneumonia caused by new coronavirus infection.
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
- Single (Participant)
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
- •2019-nCoV nucleic acid test was positive.
- •CT of the lung conformed to the manifestation of viral pneumonia.
排除标准
- •Patients who meet any of the contraindications in the experimental drug labeling
- •Patients who do not want to participate in this clinical study
研究组 & 干预措施
Abidol hydrochloride was added on the basis of group I.
Abidol hydrochloride 0.2g once,3 times a day,2 weeks
干预措施: Abidol hydrochloride (Drug)
Oseltamivir was added on the basis of group I.
Oseltamivir 75mg once,twice a day,2 weeks
干预措施: Oseltamivir (Drug)
Lopinavir/ritonavir was added on the basis of group I.
Lopinavir/ritonavir 500mg once,twice a day,2 weeks
干预措施: Lopinavir/ritonavir (Drug)
结局指标
主要结局
Rate of disease remission
时间窗: two weeks
A: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2\> 93% or PaO2/FiO2\>300mmHg (1mmHg=0.133Kpa);
Time for lung recovery
时间窗: two weeks
Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
次要结局
- Rate of no fever(two weeks)
- Rate of respiratory symptom remission(two weeks)
- Rate of lung imaging recovery(two weeks)
- Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery(two weeks)
- Rate of undetectable viral RNA(two weeks)