EUCTR2020-001754-21-FR进行中（未招募）1 期
An open prospective randomized therapeutic trial using ANAKINRA or TOCILIZUMAB alone or in combination with RUXOLITINIB in severe stage 2b and 3 COVID-19 disease - INFLAMMACOV
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients older than 18 and younger than 75, potentially eligible for admission in ICU
- •-with proven infection with COVID19, using at least one positive pharyngeal polymerase chain reaction (PCR) test
- •-COVID19 infection at stage 2b or 3
- •-Ability to provide informed consent signed by study patient or legally acceptable representative
- •1/ Stage 2b: hypoxemia necessitating oxygen therapy>5l/min in order to maintain SpO2>94% (in conventional hospitalization unit or ICU) and CRP>150 mg/l
- •2/ Stage 3: Moderate or severe ARDS necessitating invasive mechanical ventilation with a PaO2/FiO2<200 during more than 24hours
- •3/Etremely severe stage 3:
- •a) very severe ARDS defined by invasive mechanical ventilation and requirement for veno-venous extracorporeal membrane oxygenation (ECMO)
- •b) or ARDS associated with at least on the following:
- •-Shock with requirement for continuous IV adrenalin infusion>3mg/h
- •-Myocarditis with cardiogenic shock
- •-Oligo-anuric acute renal insufficiency or requirement for extrarenal epuration
- •-Hemophagocytic syndrome associated with blood cytopenia or hyperferritinemia>5000 micrograms/l
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •-Patients younger than 18 or older than 75
- •-non-eligible for ICU
- •-Patients without legal rights
- •-No personal or familial consent
- •-Ongoing pregnancy
- •-Patient being treated for Anakinra, tocilizumab, or ruxolitinib for an underlying condition.
- •- Patient already included in another therapeutic trial to modulate inflammation
- •-Uncontrolled bacterial or fungal infection
- •-Hypersensitivity to anakinra
- •-Hypersensitivity to tocilizumab
- •- hypersensitivity to ruxolitinib
研究者
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