EUCTR2020-001513-20-IT进行中（未招募）1 期
se of Defibrotide to reduce progression of acute respiratory failure rate inpatients with COVID-19 pneumonia - Defibrotide in COVID19
OSPEDALE SAN RAFFAELE0 个研究点目标入组 50 人开始时间: 2020年6月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •Documented COVID-19 pneumonia: defined as upper respiratory tract swab positive for COVID-19 and/or imaging at computed tomography scan
- •suggestive of COVID-19 pneumonia
- •SaO2 of 92% or less without oxygen support, or reduction of 3% from basal value of SaO2, or a ratio of PaO2/FiO2 below 300.
- •Any gender
- •Age >= 18 years
- •Written informed consent or as per Ethical Committee indication in case of patients not able to express written informed consent
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Onset of COVID-19 pneumonia >14 days
- •Orotracheal intubation
- •Uncontrolled systemic infection (other than COVID-19)
- •Concomitant use of thrombolytic therapy or systemic anticoagulant therapy
- •Haemodynamic instability, defined as inability to maintain mean arterial pressure with single pressor support
- •Hypersensitivity to the active substance or to any of the excipients of the experimental drug
- •Patients who, based on the investigator's clinical judgement, are not able to receive the treatment
- •Pregnancy or breastfeeding patient
研究者
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