NCT04377334Unknown2 期
Prospective Phase II Study: MSCs in Inflammation-Resolution Programs of SARS-CoV-2 Induced ARDS
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- lung injury score
研究概览
简要总结
To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID-19-positive subject
- •Horowitz index ≤ 200
- •Bilateral opacities on frontal chest radiograph, and
- •requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation
- •no clinical signs of left atrial hypertension detected via echocardiography, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.
- •Subject's Age ≥ 18 years
排除标准
- •COVID-19-negative subject
- •Subject's Age < 18 years
- •More than 7 days since initiation of mechanical ventilation
- •Patient, surrogate or physician not committed to full intensive care support.
- •Positive Pregnancy test at the time of screening.
- •Patients dependent on the sponsor, investigator and their employees, as well as persons dependent on the manufacturer of the investigational drug
结局指标
主要结局
lung injury score
时间窗: day 10
improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points
次要结局
- phenotype(day 0, 1, 2, 3, 10 and 15)
- complement molecules (C5-C9)(day 0, 5 and 10)
- Survival(day 10 and 28)
- lymphocyte subpopulations(day 0, 3, 5 and 10)
- SARS-CoV-2-specific antibody titers(day 0, 5 and 10)
- D-dimers(day 0, 1, 2, 3, 10 and 15)
- cytokines(day 0, 1, 2, 3, 10 and 15)
- chemokines(day 0, 1, 2, 3, 10 and 15)
- extubation(day 28)
- pro-resolving lipid mediators(day 0, 1, 2, 3, 10 and 15)
研究者
研究点 (2)
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