NCT04888949已完成2 期
An Phase2 Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Ventilator Free Days
研究概览
简要总结
Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.
详细描述
Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SARS-CoV-2 infection is confirmed on antigen test or PCR test
- •Pulmonary infiltrative shadow is confirmed on chest X-ray test
- •PaO2/FiO2 <=200mmHg at the time of screening
排除标准
- •Continue treatment for Pneumonia before SARS-CoV-2 infection
- •SOFA score >= 15
- •Infection type on DIC diagnosis criteria >= 4
- •Deep Venous Thrombosis
结局指标
主要结局
Ventilator Free Days
时间窗: Day 28
Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 InfectionSevere Acute Respiratory Syndrome Coronavirus 2NCT04522986Rohto Pharmaceutical Co., Ltd.6
招募中
2 期
Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory FailureHypercoagulabilityFibrinolysis ShutdownAcute Respiratory FailureNCT05540834South West Sydney Local Health District70
已完成
2 期
To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infection to PneumoniaCOVID-19NCT04500132Enzychem Lifesciences Corporation63
终止
1 期
SP16 as a Therapeutic for COVID-19 Induced ARDSSARS CoV 2 InfectionPneumoniaNCT05135624Serpin Pharma, LLC2
已完成
2 期
Comparison of Two Methods of High Frequency Oscillatory Ventilation in Individuals With Acute Respiratory Distress SyndromeRespiratory Distress Syndrome, AdultNCT00399581Johns Hopkins University100