A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 649
- 试验地点
- 54
- 主要终点
- Time to Hospital Discharge or "Ready for Discharge" up to Day 28
研究概览
简要总结
This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with 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
- 12 Years 至 —（Child, 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
Remdesivir + Tocilizumab (RDV+TCZ)
Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.
干预措施: Remdesivir (Drug)
Remdesivir + Tocilizumab (RDV+TCZ)
Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.
干预措施: Tocilizumab (Drug)
Remdesivir + Placebo (RDV+Placebo)
Participants assigned to the RDV+ placebo arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ-placebo on Day 1.
干预措施: Remdesivir (Drug)
Remdesivir + Placebo (RDV+Placebo)
Participants assigned to the RDV+ placebo arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ-placebo on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Hospital Discharge or "Ready for Discharge" up to Day 28
时间窗: Up to Day 28
Defined as days from randomization to hospital discharge or "Ready for Discharge" not followed by ordinal scale category \>1, hospital readmission or death. Hospital discharge or "Ready for Discharge" is defined as an ordinal score of 1 on the 7-point ordinal scale. Participants who die are censored at Day 28. 1. Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or \</= 2L supplemental oxygen) 2. Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen 3. Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen 4. ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen 5. ICU, requiring intubation and mechanical ventilation 6. ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) 7. Death
次要结局
- Time to Mechanical Ventilation or Death up to Day 28(Up to Day 28)
- Time to Death up to Day 60(Up to Day 60)
- Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 7(Day 7)
- Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 21(Day 21)
- Proportion of Participants Who Are Alive and Free of Respiratory Failure at Day 28 and Day 60 (Participants Requiring Mechanical Ventilation at Baseline)(Day 28 and Day 60)
- Difference in Mortality at Days 14, 28, and 60(Days 14, 28, and 60)
- Time to Recovery up to Day 28(Up to Day 28)
- Proportion of Participants Who Are Discharged or "Ready for Discharge" up to Day 28(Up to Day 28)
- Proportion of Participants Who Require Initiation of Mechanical Ventilation Post-baseline or Die up to Day 28(Up to Day 28)
- Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 14(Day 14)
- Time to Death up to Day 28(Up to 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(Up to Day 28)
- Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 28(Day 28)
- Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 60(Day 60)
- Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline (Participants Who Did Not Require Mechanical Ventilation at Baseline)(Day 28 and Day 60)
- Duration of Mechanical Ventilation (Participants Requiring Mechanical Ventilation at Baseline) up to Day 28(Up to Day 28)