The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mortality rate (In hospital)
研究概览
简要总结
A randomized clinical trial designed and intended to evaluate the efficacy of Dexamethasone and Methylprednisolone as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by coronavirus disease 19 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe COVID-19 requires hospitalization. SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.
排除标准
- •Participants with uncontrolled clinical status who were hospitalized from the before.
- •Contraindication / possible drug interaction.
- •Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease, pregnancy, Corpulmonale, etc.
研究组 & 干预措施
Group A: Dexamethasone
Dexamethasone (20 mg/iv/daily/from Day 1 of randomization, followed by a tapering dose according to the patient's condition.
干预措施: Dexamethasone (Drug)
Group B: Methylprednisolone
Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution)
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Mortality rate (In hospital)
时间窗: Following randomization 30 days.
Clinical improvement
时间窗: Following randomization 30 days.
The number of participants with "Clinical improvement" determined by the improvement of individual presenting symptoms of the COVID19; changes in radiological and laboratory values.Patient admitted in general bed requiring High Dependency Unit (HDU), and an HDU patient requiring Ventilator or Intensive care support.
次要结局
- Changes in Oxygen level(Following randomization 30 days.)
- Ventilator free days(Following randomization 30 days.)