A Phase II, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Patients With Moderate to Severe ARDS Due to COVID-19
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Survival
研究概览
简要总结
This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.
详细描述
This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens. The study will enroll up to 40 Patients into two cohorts, randomized 1:1 to receive active study drug plus standard treatment or placebo (LRS) plus standard treatment. On the treatment (Day 0) Cohort 1 will receive a single IV dose of hMSCs Cohort 2 will receive Lactated Ringer's Solution. A second dose of MSCs or LRS will be given to Cohort 1 or Cohort 2, respectively on Day 3 after the first dose. Patients who discontinue the study before Month 1 for reasons other than adverse events will be replaced.
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)
盲法说明
This is double-blind study
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
- •Laboratory-confirmed diagnosis of COVID-19 <= 14 days prior to randomization
- •The presence of moderate to severe Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin Definition:
- •Bilateral chest radiograph infiltrates.
- •PaO2:FiO2 ratio of less than
- •Absence of other clinical conditions that could present in a similar manner (non-infectious pneumonitis, cardiogenic pulmonary edema)
- •Absence of moribund state that would indicate imminent demise and poor chance of survival.
排除标准
- •Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with a positive pregnancy test on screening day will be excluded.
- •Breastfeeding mothers
- •Patients on ECMO
- •Receiving concurrent treatment with an investigational agent in a clinical trial.
- •Exception: Use of COVID-19 convalescent plasma is permitted.
- •More than 72hrs on mechanical ventilation before randomization
- •Receiving concurrent investigational vaccine
结局指标
主要结局
Survival
时间窗: 14 days post treatment
Number of patients alive at day 14 post treatment
次要结局
- Number of patients with treatment-related adverse events as assessed by CTCAE v4.0(9 months)