An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate and time of entering the critical stage
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 different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.
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
- •1.Meet the definition of severe pneumonia(Comply with any of the followings):
- •Shortness of breath,RR≥30 bpm;
- •In a resting state:SPO2≤93%;
- •PaO2/FiO2≤300mmHg.
- •2.2019-nCoV nucleic acid test was positive.
- •3.CT of the lung conformed to the manifestation of viral pneumonia.
排除标准
- •dying state (i.e. survival time is less than 24 hours);
- •progressive malignant tumor with life expectancy less than 6 months;
- •immunosuppressive status(patients using immunosuppressants or chemotherapeutic drugs)
- •underlying diseases requiring long-term glucocorticoid treatment in the past 6 months or short-term glucocorticoid therapy in the past 4 weeks;
- •patients with glucocorticoid taboos
研究组 & 干预措施
Methylprednisolone(40~80mg/d)
干预措施: Methylprednisolone (Drug)
Methylprednisolone(<40mg/d)
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Rate and time of entering the critical stage
时间窗: day 7
the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.
Rate of disease remission
时间窗: day 7
For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2\>93% or PaO2/FiO2 \>300mmHg.
次要结局
- Rate of normal tempreture(day 7)
- Rate of respiratory symptom remission(day 7)
- Rate of laboratory indicator recovery(day 7)
- Rate of lung imaging recovery(day 7)
- Rate of undetectable viral RNA(day 7)