Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 453
- 试验地点
- 1
- 主要终点
- Survival without needs of invasive ventilation at day 14
研究概览
简要总结
The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19).
Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R.
The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort.
Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation.
Patients who will chose not to receive Tocilizumab will receive standard of cares.
Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included in the CORIMUNO-19 cohort
- •Patients belonging to the following group:
- •Requiring ≥ 3L/min of oxygen
- •WHO progression scale = 5
- •No NIV or High flow
排除标准
- •Patients with exclusion criteria to the CORIMUNO-19 cohort.
- •Known hypersensitivity to Tocilizumab or DXM or to any of their excipients.
- •Pregnancy
- •Current documented bacterial infection not controlled by antibiotics.
- •certain evolving viral diseases (especially active herpes, chickenpox, shingles),
- •psychotic states still not controlled by treatment,
- •live vaccines in the previous 4 weeks,
- •Active tuberculosis or disseminated strongyloidiasis
- •Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication:
- •Absolute neutrophil count (ANC) ≤ 1.0 x 109/L
- •Haemoglobin level: no limitation
- •Platelets (PLT) < 50 G /L
- •SGOT or SGPT > 5N
研究组 & 干预措施
Dexamethasone
Dexamethasone : 10 mg once daily for the first five days (day 1 to day 5) then 5 mg per day for up to 5 days, 2.5mg per day for up to 4 days (or until oxygen supply independency if sooner)
干预措施: Dexamethasone (Drug)
Dexamethasone + Tocilizumab
Dexamethasone : 10 mg once daily for the first five days (day 1 to day 5) then 5 mg per day for up to 5 days, 2.5mg per day for up to 4 days (or until oxygen supply independency if sooner)
+Tocilizumab 8mg/kg D1 and if no response (No decrease of oxygen requirement) a second fixed dose of 400mg wil be administered at D3
干预措施: Tocilizumab (Drug)
Dexamethasone + Tocilizumab
Dexamethasone : 10 mg once daily for the first five days (day 1 to day 5) then 5 mg per day for up to 5 days, 2.5mg per day for up to 4 days (or until oxygen supply independency if sooner)
+Tocilizumab 8mg/kg D1 and if no response (No decrease of oxygen requirement) a second fixed dose of 400mg wil be administered at D3
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Survival without needs of invasive ventilation at day 14
时间窗: day 14
Survival without needs of invasive ventilation at day 14. Thus, events considered are mechanical (invasive) ventilation or death. A new DNR order will be considered as an event at the actual date of care limitation.
次要结局
- Survival without needs of ventilator utilization at day 14(14 days)
- Cumulative incidence of oxygen supply independency at 14 and 28 days(14 and 28 days)
- WHO progression scale at day 7 and 14(day 7 and day 14)
- Overall survival at 14, 28, 60 and 90 days(14, 28, 60 and 90 days)
- Survival without needs of mechanical ventilation at day 1(day 1)
- Cumulative incidence of discharge alive at 14 and 28 days(14 and 28 days)