EUCTR2020-002632-75-IT进行中（未招募）1 期
COVID-19- Multicenter, open-label, randomised trial to assess the efficacy and tolerability of poractant alfa (porcine surfactant, Curosurf®) in hospitalized patients with SARS-COV-19 acute respiratory distress syndrome (ARDS) - NA
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
- 70
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.Male or female >/=18 and 2.Informed consent for participation in the study (refer to section 15 of the protocol for detailed informed consent procedure)
- •3.Positive 2019-nCoV rt-PCR before randomisation
- •4.PaO2/FiO2 ratio < 150 mmHg
- •5.Lung compliance 6.Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1.Any contraindications to surfactant administration e.g., pulmonary haemorrhage and pneumothorax
- •2.Weight < 40kg
- •3.Stage 4 severe chronic kidney disease (i.e., eGFR < 30)
- •4.Pregnancy
- •5.Administration of any nebulized surfactant in the 48 hours before the first poractant alfa administration
- •6.Extracorporeal membrane oxygenation
研究者
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