Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 6
- 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 controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with acute respiratory distress syndrome.
详细描述
This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with acute respiratory distress syndrome.
COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.
Acceptable standard of care treatments for COVID-19 include all approved or emergency use authorized treatments for COVID-19, even if used off-label.
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
- •Laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
- •Hospitalized with COVID-19-induced ARD or 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 COVID-19 appear to be working and the subject is clinically improving
- •A previous stem cell infusion unrelated to this trial
- •Certain medical conditions that pose a safety risk to the subject
- •Pregnant or breast feeding or planning to during the study
- •Suspected uncontrolled active bacterial, fungal, viral, or other infection
- •History of splenectomy, lung transplant, or lung lobectomy
- •Concurrent participation in another clinical trial involving therapeutic interventions
- •Expected survival or time to withdrawal of life-sustaining treatments expected to be <7 days
- •Has an existing "Do Not Intubate" order
- •Has undergone home mechanical ventilation (noninvasive ventilation or via tracheotomy) expect for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing
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 through Day 28
All-cause mortality rate at Day 28
次要结局
- All-cause mortality rate at Day 60 and Day 90(Baseline through Day 60 and Day 90)
- Number of ventilator-free days through Day 28(Baseline through Day 28)
- Number of ICU days through Day 28(Baseline through Day 28)
- Change in oxygenation(Baseline to Day 2, Day 4, Day 6, Day 14 and Day 28)
- Change in clinical status(Baseline to Day 28)