Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- All Cause Mortality at 28 Days
研究概览
简要总结
Dexamethasone has been approved for the treatment of severe COVID-19, but higher doses of steroids may be more effective. The purpose of this research study is to compare the current standard dose of dexamethasone 6 mg to a higher, weight-based dosing (0.2 mg/kg with maximum dose of 20 mg) to determine if it would be more effective against COVID-19 pneumonia.
详细描述
Treatment for COVID-19 patients with respiratory failure has been vexing, but the use of steroids has shown promise. In a recent randomized control trial, dexamethasone 6 mg once daily showed a modest decrease in mortality among hospitalized COVID-19 patients who require oxygen supplementation or invasive mechanical ventilation. Other trials have shown that the inflammatory response to COVID-19 can be further attenuated at higher dosages of dexamethasone. These higher dosages have not been well studied and have not been directly compared to the current standard dose of dexamethasone 6 mg daily. We propose that a higher dexamethasone dose, equivalent to methylprednisolone 1 mg/kg/day which is routinely used to treat other inflammatory conditions of the lungs, may be more effective than the current standard dose in reducing mortality in COVID-19 patients with respiratory failure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults greater or equal than 18 years old
- •COVID-19 infection confirmed by positive PCR test
- •Hypoxemia defined by an oxygen saturation < 94% or the need for supplemental oxygen
排除标准
- •Corticosteroid use for > 48h within the past 15 days prior to enrollment
- •Use of steroids with doses higher than the equivalent to dexamethasone 6 mg
- •Use of immunosuppressive drugs
- •Pregnant women
- •Chronic oxygen use
- •Known history of dexamethasone allergy
- •DNR / DNI
- •Patient or proxy cannot consent
研究组 & 干预措施
Weight-based dexamethasone dose
Dexamethasone 0.2 mg/kg/day IV (maximum 20 mg daily) for 10 days
干预措施: Weight-based dexamethasone dose (Drug)
结局指标
主要结局
All Cause Mortality at 28 Days
时间窗: 28 days
All cause mortality at 28 days. Comment: Primary outcome was all cause mortality at 28 days but the patients were followed until end of admission for the final disposition (death or discharge) which accounts for the differences in the primary outcome of mortality at 28 days and the total number of deaths at discharge
次要结局
- Days of Hospitalization(28 days)
- Number of Participants That Required Oxygen Supplementation a Discharge From the Hospital(Until hospital discharge)
- Subjective Symptoms at 28 Days(28 days)
- Disposition Upon Discharge(At hospital discharge)
- Duration of Invasive Mechanical Ventilation(28 days)
- Number of Participants That Required ECMO(28 days)
- Number of Participants That Required Tracheostomy(28 days)
- Number of Participants That Developed Secondary Bacterial or Fungal Infections(28 days)
- Number of Participants That Developed Clinically Significant Hyperglycemia(28 days)
- Number of Participants Admitted to the ICU(28 days)
- Days of Stay in the Intensive Care Unit(28 days)
- Number of Participants That Required Higher Levels of Oxygen Supplementation(28 days)
- Number of Participants That Required Invasive Mechanical Ventilation(28 days)
研究者
Stella S Hahn, MD
Associate Medical Director, Northwell Sleep Disorders Center
Northwell Health