Comparing the effectiveness of Dexamethasone versus Methylprednisolone in patients with moderate Covid 19 - A Randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mortality during hospital stay
研究概览
简要总结
The aim of the study is to compare and explore the effectiveness of dexamethasone versus methylprednisolone in the treatment of novel corona virus pneumonia and to identify effective steroid treatment that may be beneficial to improve clinical outcome for hospitalised covid 19 patients in the future.
This is a randomised controlled trial. Patients who fulfill the inclusion and exclusion criteria from covid ward in SRM Medical college hospital and research centre will be included in the study. After obtaining informed consent, patients with moderate covid 19 infection will be grouped into two categories, group A and group B randomly in the ratio of 1:1 using computer generated randomisation sequence. Block randomisation with a block size of 10 will be used. Group A will receive Inj Dexamethasone 6mg or 8mg IV OD for 7 days and group B will receive Inj Methylprednisolone (in equivalent dose to dexamethasone) IV OD for 7 days. 1.5mg of dexamethasone is equal to 8mg of methylprednisolone. During the duration of seven days, regular clinical assessment for improving or deteriorating signs and symptoms will be assessed. At the end of the study on day 7, patient will be assessed both clinically and lab wise and outcome will be measured. If the duration of hospital stay is prolonged for more than 7 days, then final clinical and indicated lab assessment will be done on the day of discharge. Descriptive statistics will be done for all data and suitable statistical tests of comparison will be done. P value < 0.05 considered as significant. Data will be analysed using SPSS version 20.0
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Hospitalized patients with moderate SARS-COV-2 infection laboratory confirmed by RT-PCR (Moderate COVID 19- SPO2 <94% Under room air and requiring supplemental oxygen for hypoxemia Respiratory rate 24-30/min NLR >5 CRP 50-100 mg/l Serum ferritin 600-1500 ng/ml Serum LDH 300-500 IU/l D Dimer 0.5-1.0 mic/ml IL-6 20-100 pg/ml CT chest showing 25-75% infiltrates).
排除标准
- •1.Patients with mild and severe covid pneumonia 2.Patients who are already on steroid treatment for any underlying condition 3.Patients already started on antivirals 4.Pregnant or lactating women 5.Any known contraindication to short term corticosteroid like severe immunosuppression, HIV infection or any other immunosuppressant usage Â.
结局指标
主要结局
Mortality during hospital stay
时间窗: Day 1 - Day 7
次要结局
- 1.Time taken to wean off supplemental oxygen(2.Need for mechanical ventilation)