Randomized Study Of the Effect of Dexamethasone and Methylprednisolone on levels of IL-6 and clinical outcome in severe COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Length of hospital stay (LOS).
研究概览
简要总结
This study is a randomised,parallel group,single-centre trial comparing the effect of methylprednisolone 1mg/kg intravenous once a day for 3 days and intravenous dexamethasone 6 mg once a day for 3 days in 40 patients in India. The primary outcome measures are difference in IL-6 level from baseline,days to ventilator liberation, length of hospital stay, in hospital all cause mortality and the secondary outcomes are time to fever resolution, levels of biomarkers(CRP,D dimer,Ferritin) on day 1 and day 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years old Both sex Lab.
- •Confirmed COVID-19 cases with ARDS.
排除标准
- •Mild and moderate COVID-19 Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents Pregnant or lactating women Patients already on steroids Patients with High Procalcitonin level.
结局指标
主要结局
Length of hospital stay (LOS).
时间窗: Day 1 and Day 3 for IL-6 level
Primary outcomes:
时间窗: Day 1 and Day 3 for IL-6 level
The secondary outcomes
时间窗: Day 1 and Day 3 for IL-6 level
Difference in IL-6 level from baseline.
时间窗: Day 1 and Day 3 for IL-6 level
Days to ventilator liberation
时间窗: Day 1 and Day 3 for IL-6 level
In-hospital all-cause mortality.
时间窗: Day 1 and Day 3 for IL-6 level
Time to fever resolution
时间窗: Day 1 and Day 3 for IL-6 level
Levels of bio-markers (CRP, D dimer, Ferritin) on Day 1 and Day 3.
时间窗: Day 1 and Day 3 for IL-6 level
次要结局
- patient details like baseline demographic data, laboratory reports – lymphocyte count, CRP, procalcitonin, Ferritin, D-dimer and clinical parameters including length of hospital stay and days in ventilator will be recorded before and after treatment with dexamethasone/methylprednisolone.