A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 377
- 试验地点
- 44
- 主要终点
- Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28
研究概览
简要总结
This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia, and b) include an optional long-term extension for eligible participants to explore the long-term sequelae of resolved COVID-19 pneumonia.
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, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given.
干预措施: Placebo (Drug)
Tocilizumab
Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28
时间窗: Up to Day 28
Cumulative proportion is measured as a percentage of participants meeting the endpoint.
次要结局
- Time to Hospital Discharge or "Ready for Discharge" (as Evidenced by Normal Body Temperature and Respiratory Rate, and Stable Oxygen Saturation on Ambient Air or >/= 2 Liters (L) Supplemental Oxygen)(Up to Day 28)
- Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (Whichever Occurred First)(Up to Day 28)
- Mortality Rate by Day 28(Up to Day 28)
- Clinical Status on 7-Category Ordinal Scale at Day 28(Day 28)
- Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status(Up to Day 28)
- Percentage of Participants With Adverse Events(Up to Day 60)