A Phase 1 Study to Assess the Safety of Living Related Donor Derived T Regulatory Cell Therapy in Subjects With COVID 19 Induced Acute Respiratory Distress Syndrome (ARDS)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The number of participants that experience the occurrence of infusion associated adverse events (AEs)
研究概览
简要总结
This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS.
Study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years to 75 years
- •All patients at entry are required to be at high risk for the development of ARDS or receiving mechanical ventilatory support
- •Provision of signed written informed consent from the patient or patients legally authorized representative
- •Only patients who are committed to full life support (Do not resuscitate (DNR) allowed)
- •Initiation of study drug within 120 hours of the diagnosis of acute lung injury (ALI)/ARDS
- •COVID positive by PCR testing
排除标准
- •Concurrent illness that shortens life expectancy to less than 6 months
- •Inability to obtain adequate study follow-up
- •Greater than 90 hours since first meeting ARDS criteria per the Berlin definition
研究组 & 干预措施
T regulatory cell infusion
Infusion will be administered to the patient within 72 hours of collection from donor.
干预措施: T regulatory cells (Biological)
结局指标
主要结局
The number of participants that experience the occurrence of infusion associated adverse events (AEs)
时间窗: within 6 hours of study infusion
The number of patients who receive the target dose for one or more intravenous infusions
时间窗: up to 14 days (approximately 1.5 hours average per infusion)
Patients will receive 1 or 2 infusions, with the possibility of a second infusion given 14 days after the initial infusion.
The number of patients that experience treatment emergent AEs
时间窗: 6 to 24 hours after infusion treatment
Treatment related adverse events or serious adverse events
次要结局
- World Health Organization (WHO) COVID-19 ordinal scale score for clinical improvement(assessed at 28 days post-infusion)
- Mortality following initial infusion(28 days)
- Change in Sequential Organ Failure Assessment (SOFA) Score over time(up to 14 days (assessed at baseline, and 1, 3, 5, 7, and 14 days post-infusion))
- The ratio of average daily partial pressure of oxygen (PaO2) to average fraction of inspired oxygen (FiO2) (PaO2:FiO2) over time(up to 14 days (assessed at baseline, and 3, 7, and 14 days post-infusion))