C5a Receptor Expression in Circulating Myeloid Cells in ARDS Secondary to COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Show an overexpression of C5a receptor in patients with ARDS secondary to COVID-19 compared to control patients (patients with COVID-19 without respiratory distress and healthy volunteers).
研究概览
简要总结
The pathophysiology of ARDS is linked to an uncontrolled inflammatory response at the level of alveolo-capillary membrane, mediated by neutrophils and mononuclear cells. The complement system and anaphylatoxin C5a have shown central role in the recruitment of these pro-inflammatory cells and more broadly in the genesis of cytokinic storm syndrome. C5a acts via receptors C5aR and C5L2.
This is a preliminary study aimed at studying the expression of the C5a receptor on myeloid cells in peripheral blood of patients with ARDS secondary to COVID-19.
This study has of primary objective to show there is an overexpression of the C5a receptor in patients with ARDS secondary to COVID-19 compared to control patients (patients with COVID-19 without respiratory distress and healthy volunteers).
The medium-term objective is to develop a clinical trial to test the effectiveness of anti-C5aR antibody in this condition.
详细描述
The pathophysiology of ARDS is linked to an uncontrolled inflammatory response at the level of alveolo-capillary membrane, mediated by neutrophils and mononuclear cells. The complement system and anaphylatoxin C5a have shown central role in the recruitment of these pro-inflammatory cells and more broadly in the genesis of cytokinic storm syndrome. C5a acts via receptors C5aR and C5L2.
This is a preliminary study aimed at studying the expression of the C5a receptor on myeloid cells in peripheral blood of patients with ARDS secondary to COVID-19.
This study has of primary objective to show there is an overexpression of the C5a receptor in patients with ARDS secondary to COVID-19 compared to control patients (patients with COVID-19 without respiratory distress and healthy volunteers).
The medium-term objective is to develop a clinical trial to test the effectiveness of anti-C5aR antibody in this condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •For patients in resuscitation unit with ARDS linked to COVID-19:
- •Patient under invasive mechanical ventilation
- •PaO2 / FiO2 <300
- •PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample
- •For control patients with COVID-19 without ARDS
- •Oxygen flow always less than 5 L / min
- •PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample
- •No passage in resuscitation unit
- •Favorable evolution
排除标准
- •Patient deprived of liberty
- •Patient's refusal to participate at study
- •Patient for whom therapeutic limitation measures such as non-admission to intensive care have been issued
- •Medullar aplasia
研究组 & 干预措施
COVID-19 PATIENTS
Two blood samples (40mL) at 2 different points in time:
- Within the first 72 hours of medical care in resuscitation unit or department.
- Between the 5th and the 10th day of medical care (ideally at the end of the first week) or on the day of discharge of patient if it is earlier, or of death if it takes place earlier.
干预措施: draw blood (Other)
结局指标
主要结局
Show an overexpression of C5a receptor in patients with ARDS secondary to COVID-19 compared to control patients (patients with COVID-19 without respiratory distress and healthy volunteers).
时间窗: 72 hours
The endpoint is the expression of the C5a receptor (C5aR) in peripheral blood myeloid cells, expressed as a percentage of cells expressing C5a receptor and as median fluorescence intensity (MFI), during the first 72 hours of patient management in resuscitation unit.
次要结局
未报告次要终点