An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Two Therapeutic Schemes(Abidol Hydrochloride,Abidol Hydrochloride Combined With Interferon Atomization)in the Treatment of 2019-nCoV Pneumonia.
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time for lung recovery
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 two therapeutic schemes(abidol hydrochloride,abidol hydrochloride combined with interferon atomization)in the treatment of 2019-nCoV viral pneumonia, so as to provide reliable evidence-based medicine for the treatment of viral pneumonia caused by 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
- 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. 2)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
Standard symptomatic support therapy (SMT) plus abidol hydrochloride(0.2g, 3 times a day).
干预措施: Abidol hydrochloride (Drug)
Abidol Hydrochloride combined with Interferon atomization
Interferon(PegIFN-α-2b) atomization was added(45ug, add to sterile water 2ml, twice a day) on the basis of group I.
干预措施: Abidol Hydrochloride combined with Interferon atomization (Drug)
结局指标
主要结局
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.
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);
次要结局
- Rate of undetectable viral RNA(two weeks)
- Rate of respiratory symptom remission(two weeks)
- Rate of CRP,ES,Biochemical criterion (CK,ALT,Mb)recovery(two weeks)
- Rate of no fever(two weeks)
- Rate of lung imaging recovery(two weeks)