Efficacy and Safety of ANAkinra During Adult " COVID-19 " With Aggravating Respiratory Symptoms: a Multicenter Open-label Controlled Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Treatment success
研究概览
简要总结
The main objective of the ANACONDA-COVID-19 trial is to assess the efficacy of Anakinra + optimized Standard of Care (oSOC) as compared to oSOC alone on the condition of patients with COVID-19 infection and worsening respiratory symptoms. Success defined as patient alive and free of invasive mechanical ventilation (IMV) and free of Extracorporeal Membrane Oxygenation (ECMO) at Day 14.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Optimized Standard of Care (oSOC)
The control group will receive optimized standard of care alone, including all treatments authorized for COVID-19 by the French Health Ministry and/or the center COVID-19 therapeutic committees at inclusion and during the follow-up.
干预措施: oSOC (Drug)
Anakinra plus Optimized Standard of Care (oSOC)
The experimental group will receive Anakinra plus optimized Standard of Care. The patients will receive Intravenous injection (IV) of Anakinra 400mg/day (100mg IV every 6 hours) at Day 1, 2 and 3. From Day 4 to Day 10, the patient will receive IV injection of Anakinra 200mg/day (100mg every 12 hours). The total duration of Anakinra is 10 Days
干预措施: Anakinra plus oSOC (Drug)
结局指标
主要结局
Treatment success
时间窗: After 14 days of treatment
The primary endpoint is treatment success at Day 14, defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).
次要结局
- Change in inflammatory parameter(From baseline to Day 3, Day 10, Day 14 and Day 28)
- Overall survival(After 3 days, 10 days, 14 days and 28 days of treatment)
- Change in National Early Warning Score (NEW)from baseline to Day 3, Day 10, Day 14 and Day 28(After 3 days, 10 days, 14 days and 28 days of treatment)
- Hospital length of stay(Up to 28 days)
- Time to ICU admission(Up to 28 days)
- OMS progression scale (on a 7 point ordinal scale)(After 3 days, 10 days, 14 days and 28 days of treatment)
- Treatment success(After 3 days, 10 days and 28 days of treatment)
- Time to ventilatory support(Up to 28 days)
- Predictors of efficacy of Anakinra(After 14 days of treatment)
- ICU parameter(Up to 28 days)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Up to 28 days)