NCT04728698撤回2 期
Treatment of COVID-19-Induced Acute Respiratory Distress: A Phase 2 Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mortality at Day 28
研究概览
简要总结
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 (SOC) treatments for COVID-19 infection in hospitalized subjects with ARD/ARDS.
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
- Double (Participant, Investigator)
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
- •Provides informed consent
- •Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen
- •Is hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 ≤
- •The PaO2/FiO2 may be estimated from pulse oximetry or determined by arterial blood gas
- •Requires oxygen supplementation at screening
- •Is willing to follow contraception requirements
排除标准
- •Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
- •A previous MSC infusion unrelated to this trial
- •Have any of the following medical conditions:
- •Cardio-pulmonary resuscitation within 14 days of randomization
- •Uncontrolled or untreated symptomatic arrhythmias. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening may enroll
- •Myocardial infarction within the last 6 weeks
- •Congestive heart failure (NYHA Grade 3 or 4)
- •Pulmonary hypertension (WHO Class III/IV)
- •Currently receiving extracorporeal life support or membrane oxygenation (ECLS/ECMO)
- •Alanine aminotransferase (ALT) ≥ 5x upper limit of normal (ULN)
- •Relevant renal impairment (eGFR < 50 mL/min)
- •Any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study
- •Pregnant or breast feeding or planning for either during the study
- •Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19)
- •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.
- •Do Not Intubate order;
- •Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except 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
Experimental
Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)
干预措施: COVI-MSC (Drug)
Placebo
Placebo Comparator
Excipient
干预措施: Placebo (Drug)
结局指标
主要结局
Mortality at Day 28
时间窗: Randomization through Day 28
All-cause mortality at Day 28
次要结局
- Improvement in oxygenation(Randomization to Day 2, Day 4, Day 6, Day 14, Day 28)
- Mortality at Days 60 and 90(Randomization through Day 60 and Day 90)
- SOFA score at Day 28(Randomization to Day 28)
- Number of ventilator-free days(Randomization through Day 28)
研究者
研究点 (1)
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