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
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Incidence of treatment-emergent adverse events (safety)
研究概览
简要总结
This is a Phase 2 study to assess COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory distress / acute respiratory distress syndrome.
详细描述
This is a Phase 2 multicenter (United States and Mexico) study to assess the safety and preliminary efficacy of COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory stress (ARD) / acute respiratory distress syndrome (ARDS).
Subjects will be randomized 1:1 COVI-MSC to 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
- •Laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen (can be documented from inpatient medical record)
- •Hospitalized with at least "severe" COVID-19-induced ARD or ARDS as defined per FDA Guidance; COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
- •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
- •Has severe ARDS with a PaO2/FiO2 (PF ratio) ≤ 100 mmHg or SpO2/FiO2 ratio < 150 mmHg with PEEP ≥ 5cm H2O
- •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 (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
- •Has an existing "Do Not Intubate" order
- •Has undergone 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 (eg, obstructive sleep apnea)
- •Has 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
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
Incidence of treatment-emergent adverse events (safety)
时间窗: Baseline through study completion at Day 90
Safety as assessed by incidence of treatment-emergent AEs (TEAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Incidence of severe adverse events (safety)
时间窗: Baseline through study completion at Day 90
Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality using CTCAEv5 criteria
Incidence of infusion-related adverse events (safety)
时间窗: Baseline to Hour 4
Safety as assessed by incidence of Infusion-related AEs (IrAEs) by type, frequency, severity, and causality using CTCAEv5 criteria over 4 hours
All-cause mortality rate at Day 28
时间窗: Baseline through Day 28
All-cause mortality rate at Day 28
Incidence of all adverse events (AEs) (safety)
时间窗: Baseline through study completion at Day 90
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)
次要结局
- Number of ICU days through Day 28(Baseline through Day 28)
- All-cause mortality rate at Day 60 and 90(Baseline through Day 60 and Day 90)
- Number of ventilator-free days through Day 28(Baseline through Day 28)
- Change in clinical status(Baseline to Day 28)
- Change in oxygenation(Baseline to Day 14 Day 28, and Day 60)