EUCTR2020-001682-36-ES进行中（未招募）1 期
Double-blind, placebo-controlled phase I/II clinical trial to evaluate the safety and efficacy of allogeneic mesenchymal stem cells (MSV®-allo) in acute respiratory failure in patients with COVID-19 pneumonia. - Treatment of COVID.19 with allogeneic mesenchymal cells (MSV®).
CITOSPIN S.L.0 个研究点目标入组 24 人开始时间: 2020年4月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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. Women or men of equal or more than 18 years of age 2. SARS-CoV-2 infection confirmed by
- •molecular testing. 3. Admitted to the Intensive Care Unit with pneumonia secondary
- •to COVID-19 infection in the last 48 hours, who meet at least one of these criteria:
- •to. Respiratory distress. yes. Respiratory rate (RR) equal or more than 30 rpm. C. Basal oxygen
- •saturation at rest equal or less than 93%. re. Arterial partial pressure of oxygen (PaO2) / inspiratory
- •fraction of oxygen (FiO2) equal or less than 300 mmHg. 4. Compliance of the patient or his legal
- •representative for participation in the study.
- •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 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Active tumor disease.
- •2. Pregnancy.
- •3. Participation in another active clinical trial.
- •4. Any circumstance that in the researcher's opinion justifies the patient's non-participation in the trial.
- •5. Not consent to participation.
研究者
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