EUCTR2020-002632-75-GB进行中（未招募）1 期
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) - COVID19 - Curosurf_ARDS_COV19
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
- 85
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 = 80 years of age
- •2. Informed consent for participation in the study (refer to section 15 for detailed informed consent procedure)
- •3. Positive 2019-nCoV rt-PCR before randomisation
- •4. PaO2/FiO2 ratio < 150 mmHg
- •5. Lung compliance =45 ml/cmH20
- •6. Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration*
- •*[Criterion not applicable to the ECMO additional cohort]
- •Additional inclusion criterion for ECMO-cohort:
- •7. Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration
- •8. Supported with vvECMO less than 48 hours before
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
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*
- •* [Exclusion criterion NOT applicable for patients eligible for the ECMO-cohort]
研究者
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