Treatment of Non-COVID-19 Acute Respiratory Distress Syndrome: A Phase 2 Study of the Efficacy and Safety of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- All-cause mortality rate at Day 28
研究概览
简要总结
This is a Phase 2 randomized study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.
详细描述
This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.
Subjects will be randomized 2:1 to receive COVI-MSC or placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Negative for SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
- •Hospitalized with non-COVID-19-induced ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300
- •Requires oxygen supplementation at Screening
- •Willing to follow contraception guidelines
排除标准
- •Current standard of care treatments for ARDS appear to be working and the subject is clinically improving
- •A previous stem cell infusion unrelated to this trial
- •Pregnant or breast feeding or planning for either during the study
- •Suspected uncontrolled active bacterial, fungal, viral, or other infection
- •History of a splenectomy, lung transplant or lung lobectomy
- •Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
- •Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days
研究组 & 干预措施
COVI-MSC
Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4
干预措施: COVI-MSC (Biological)
Placebo
Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4
干预措施: Placebo (Drug)
结局指标
主要结局
All-cause mortality rate at Day 28
时间窗: Baseline to Day 28
All-cause mortality rate at Day 28
次要结局
- Clinical status at Day 28(Baseline to Day 28)
- All-cause mortality rate at Days 60 and 90(Baseline to Day 60 and Day 90)
- Number of ventilator-free days through Day 28(Baseline through Day 28)
- Change in oxygenation(Baseline to Day 2, Day 4, Day 6, Day 14, Day 28)
- Number of ICU days through Day 28(Baseline through Day 28)