EUCTR2020-001504-42-FR进行中（未招募）1 期
Exploratory study of the safety, tolerability and efficacy of nangibotide in mechanically ventilated patients with COVID-19 and features of systemic inflammation - A randomized, double-blind, placebo-controlled study with adaptive features.
INOTREM S.A.0 个研究点目标入组 60 人开始时间: 2020年4月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •1. Provide written informed consent (emergency consent according to local regulations where approved)
- •2. Age 18 to 75 years (inclusive)
- •3. Mechanically-ventilated patient for acute respiratory distress caused by COVID-19
- •4. Confirmed laboratory diagnosis of COVID-19 within 7 days of meeting screening criteria
- •5. Laboratory markers of severity met <24 hours after blood sample collection for at least one of the following within 7 days after the initiation of mechanical ventilation:
- •C Reactive Protein > 40 mg/L
- •Ferritin >500 µg/L
- •Lymphocyte count of <1.0x10e9/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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Invasive mechanical ventilation for more than 7 days
- •2. Known pregnancy (positive urine or serum pregnancy test)
- •3. Weight > 95 kg
- •4. Anticipated transfer to another hospital, which is not a study site within 72 hours
- •5. Expected to die within 6 months of treatment due to underlying chronic disease
- •6. Limitations of care in place during current hospital admission
研究者
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