NCT04525378Unknown1 期
Mesenchymal Stromal Cell-based Therapy for COVID-19-associated Acute Respiratory Distress Syndrome: a Pilot Clinical Study
D'Or Institute for Research and Education2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Intrahospital mortality
研究概览
简要总结
Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.
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
- •Clinical diagnosis of COVID-19 confirmed by RT-PCR;
- •Thorax CT image suggestive of viral pneumonia;
- •Respiratory failure (SaO2 <93% with O2 at 5L / min)
- •Tracheal intubation (first 48 h);
排除标准
- •Pregnancy or breastfeeding;
- •Patients with a history of cancer, chemotherapy in the past 2 years;
- •Life expectancy less than 6 months or in exclusive palliative care;
- •Severe liver failure, with Child-Pugh score> 12;
- •High probability of death in the following 48 h;
- •Previous renal failure: patients who were already on dialysis or patients with RFG <30ml / min / 1.73 m2;
- •Clinical or radiological suspicion of tuberculosis and bacterial pneumonia.
结局指标
主要结局
Intrahospital mortality
时间窗: 28 days
次要结局
- PaO2 / FiO2 ratio(Day 1, Day 2 and Day 7 after cell infusion)
- Incidence of adverse events(28 days)
- Quantification of inflammatory response markers(Day 1, Day 3 and Day 7 after cell infusion)
- Days without mechanical ventilation in 28 days(28 days)
- Incidence of secondary infections(28 days)
- Length of stay in the ICU and Hospital(28 days)
研究者
研究点 (2)
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