The Impact of Dexamethasone Versus Methylprednisolone Upon Neutrophil/Lymphocyte Ratio (NLR) in COVID-19 Diseased Patients Admitted in ICU
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Neutrophil/lymphocyte ratio (NLR)
研究概览
简要总结
we designed this study to observe the efficacy and safety of dexamethasone versus methylprednisolone in covid-19 diseased patients upon monitoring the inflammatory response and to compare the outcome when these steroids will be given in covid-19 diseased patients in our ICU.
详细描述
A written informed consent will be taken from the patients or their relatives. The study will involve adults (age 18-no limit years) who will be diagnosed covid-19 with destructive inflammatory immune response needing ICU admission to be run on steroid therapy.
Patients will be assigned randomly to two groups (30 subjects each). The study drug will be delivered in opaque bags labeled "study drug" and in (Group D) intravenous dexamethasone 8 mg/day given for 7 days, in (Group M) intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days.
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
- Double (Participant, Care Provider)
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
- •Adults (age 18-no limit years) who will be diagnosed covid-19
- •With destructive inflammatory immune response needing ICU admission to be run on steroid therapy.
排除标准
- •Severe immunosuppression like HIV (Human immunodeficiency Virus)
- •Long term use of immunosuppressant for any other chronic illness
- •Pregnant or lactating females
- •Patients who are on chronic use of corticosteroids like asthma, rheumatoid arthritis.
研究组 & 干预措施
(Group D )Dexamethasone
Intravenous dexamethasone 8 mg/day given for 7 days
干预措施: Dexamethasone (Drug)
(Group M) methylprednisolone
Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Neutrophil/lymphocyte ratio (NLR)
时间窗: 7 days
Monitoring of systemic inflammation by follow up of neutrophil/lymphocyte ratio (NLR) at days 0, 48 hour, 72 hour and at day 7 between the two study drugs
次要结局
- ICU mortality(7days)
- Interleukin-6 (IL-6) level(7days)
- ICU stay(7 days)
- Arterial oxygen tension/ inspired oxygen fraction (P/F ratio)(3 days)
- C-reactive protein (CRP) test(3 days)
研究者
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University