An Open-label, Standard Therapy as a Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of HLCM051(MultiStem) in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by Pneumonitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Healios K.K.
- 入组人数
- 35
- 试验地点
- 29
- 主要终点
- Change from baseline in systolic blood pressure(ARDS caused by COVID-19 cohort)
研究概览
简要总结
The primary object of this clinical study is to investigate the efficacy of HLCM051 in patients with ARDS caused by pneumonitis.
详细描述
The objectives of this clinical study are as follows(ARDS caused by pneumonia cohort):
- Primary objective To investigate the efficacy of HLCM051 in patients with ARDS caused by pneumonia
- Secondary objective To confirm the safety of HLCM05 in patients with ARDS caused by pneumonia
- Exploratory objective To investigate changes of biomarkers in patients with ARDS caused by pneumonia
The number of patients enrolled is 30 (20 patient in the HLCM051 group and 10 patients in the standard therapy group)
The objectives of this clinical study is as follows(ARDS caused by COVID-19 cohort):
- Exploratory objective To investigate the safety and the efficacy of HLCM051 in patients with ARDS caused by SARS-Cov-2 infection
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline in systolic blood pressure(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in systolic blood pressure(mmHg)
Change from baseline in basophils(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in basophils(%)
Change from baseline in alkaline phosphatase(ALP)(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in alkaline phosphatase(ALP)(IU/L)
Change from baseline in blood urea nitrogen(BUN)(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in blood urea nitrogen(BUN)(mg/dL)
Change from baseline in chloride(Cl)(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in chloride(Cl)(mmol/L)
Change from baseline in uric blood(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in uric blood(- to \>= 4+)
Change from baseline in urinary sediment(RBC)(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in urinary sediment(RBC)(/HPF)
Change from baseline in urinary sediment(Other)(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in urinary sediment(Other)(/HPF)
Adverse events(ARDS caused by COVID-19 cohort)
时间窗: From informed consent to 180 days after administration of the investigational product
The number and rate of adverse events
Change from baseline in pulse rate(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in pulse rate(beats/min)
Change from baseline in respiration(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in respiration(breath/min)
Change from baseline in body temperature(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in body temperature(C)
Change from baseline in hematocrit(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in hematocrit(%)
Ventilator-free days (VFD)(ARDS caused by pneumonia cohort)
时间窗: 28 days after administration of the investigational product
VFD for 28 days after administration of the investigational product
Change from baseline in diastolic blood pressure(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in diastolic blood pressure(mmHg)
Change from baseline in oxygen saturation(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in oxygen saturation(%)
Change from baseline in red blood cell count(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in red blood cell count(/uL)
Change from baseline in hemoglobin(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in hemoglobin(g/dL)
Change from baseline in neutrophils(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in neutrophils(%)
Change from baseline in monocytes(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in monocytes(%)
Change from baseline in platelet count(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in platelet count(/uL)
Change from baseline in asparate aminotransferase(AST)(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in asparate aminotransferase(AST)(IU/L)
Change from baseline in blood sugar(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in blood sugar(mg/dL)
Change from baseline in lymphocytes(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in lymphocytes(%)
Change from baseline in leukocyte count(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in leukocyte count(/uL)
Change from baseline in eosinophils(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in eosinophils(%)
Change from baseline in creatinine(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in creatinine(mg/dL)
Change from baseline in alanine aminotransferase(ALT)(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in alanine aminotransferase(ALT)(IU/L)
Change from baseline in total bilirubin(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in total bilirubin(mg/dL)
Change from baseline in sodium(Na)(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in sodium(Na)(mmol/L)
Change from baseline in potassium(K)(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in potassium(K)(mmol/L)
Change from baseline in calcium(Ca)(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in calcium(Ca)(mg/dL)
Change from baseline in urinary protein(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in urinary protein(- to \>= 4+)
Change from baseline in urinary sugar(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in urinary sugar(- to \>= 4+)
Change from baseline in urinary sediment(WBC)(ARDS caused by COVID-19 cohort)
时间窗: From screening to 180 days after administration of the investigational product
Change from baseline in urinary sediment(WBC)(/HPF)
次要结局
未报告次要终点