NCT04909892撤回2 期
A Phase 2a Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in 6-Minute Walk Distance (6MWD) at Day 60
研究概览
简要总结
This is a Phase 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.
详细描述
This is a Phase 1b multicenter study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.
COVI-MSC 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
- None
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
- •Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
- •Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
- •Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
- •Willing to follow contraception guidelines
排除标准
- •Clinically improving pulmonary status over the month prior to screening
- •Undergone 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)
研究组 & 干预措施
COVI-MSC 1 vial
Experimental
Subjects will receive intravenous infusions of COVI-MSC (one vial, ~18.5 million cells) on Day 0, Day 2, and Day 4.
干预措施: COVI-MSC (Biological)
COVI-MSC 2 vials
Experimental
Subjects will receive intravenous infusions of COVI-MSC (two vials, ~37 million cells) on Day 0, Day 2, and Day 4.
干预措施: COVI-MSC (Biological)
结局指标
主要结局
Change in 6-Minute Walk Distance (6MWD) at Day 60
时间窗: Baseline to Day 60
Change in 6MWD at Day 60
次要结局
- Change in 6MWD at Day 30(Baseline to Day 30)
- Change in biomarker levels(Baseline through Day 30)
- Change in oxygenation(Baseline to Day 30 and Day 60)
- Change in Pulmonary Function Tests (PFTs)(Baseline to Day 30 and Day 60)
研究者
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