CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Survival without needs of intubation 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 Eculizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Eculizumab is a terminal complement inhibitor that has been investigated for more than 10 years in numerous complement-mediated diseases. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Eculizumab administration to patients enrolled in the CORIMUNO-19 cohort. Eculizumab 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 Eculizumab will receive standard of care. Outcomes of Eculizumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 675 years old included in the CORIMUNO-19 cohort
- •Patients belonging to one of the 2 following groups
- •Group 1: 60 patients not requiring ICU at admission with moderate and severe pneumopathy according to the WHO Criteria of severity of COVID pneumopathy, meeting all of the 2 following criteria:
- •Respiratory symptoms with radiological findings of pneumonia
- •Severe pneumonia requiring ≥ 5L/min of oxygen to maintain SpO2 >97%
- •Group 2: 60 patients requiring ICU based on Criteria of severity of COVID pneumopathy.
- •Respiratory failure and requiring mechanical ventilation
- •Vasopressive support
- •Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating Eculizumab to reduce the risk of meningococcal infection (N meningitidis) [(Bexsero® (2 injections with a minimum of 1 month interval) + Menveo@ or Niminrex® ) and daily antibiotics (Oracilline®)]. If vaccination cannot be confirmed or if the patient cannot receive it, the participant should receive prophylactic antibiotics against meningococcal infection prior to initiating Eculizumab treatment and for at least 3 months from the last infusion of Eculizumab.
- •Female patients of childbearing potential and male patients with female partners of childbearing potential must follow protocol-specified guidance for avoiding pregnancy while on treatment and for 8 months after last dose of Eculizumab.
- •5- Body weight ≥40 kg
- •6-Patient and/or alternatively by next-of-kin must be willing and able to give written informed consent according to the applicable regulations including emergency and intensive care contexts
排除标准
- •Patients with exclusion criteria to the CORIMUNO-19 cohort.
- •Age ≥ 70 years
- •Pregnancy or lactation
- •History or unresolved Neisseria meningiditis infection
- •Ongoing sepsis, presence or suspicion of active and untreated systemic bacterial infection prior study screening and untreated with antibiotics,
- •Hypersensitivity to any ingredient contained in Eculizumab, including hypersensitivity to murine proteins.
研究组 & 干预措施
Eculizumab
Eculizumab
干预措施: Eculizumab (Drug)
结局指标
主要结局
Survival without needs of intubation at day 14
时间窗: 14 days
Survival without needs of intubation, events considered are intubation or death
Change in organ failure at day 3
时间窗: 3 days
Change in organ failure at day 3, defined by the relative variation in Sequential Organ Failure Assessment score
次要结局
- Survival at 14, 28 and 90 days(14, 28 and 90 days)
- Time to discharge(90 days)
- Time to oxygen supply independency(90 days)
- Time to negative viral excretion(90 days)
- Incidence of secondary infections(90 days)
- Vasopressor-free survival(90 days)
- Ventilator-free survival(90 days)
- 28-day ventilator-free days(28 days)
- Incidence of dialysis(90 days)
- PaO2/FiO2 ratio(days 4, 7, 14)
- Intubation free survival at day 14(Day 14)
- WHO progression scale at days 4, 7 and 14(4, 7 and 14 days)
- Rate of respiratory acidosis at day 4(4 days)
- Time to ICU discharge(90 days)