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临床试验/NCT04369820
NCT04369820已完成不适用

C5a Receptor Expression in Circulating Myeloid Cells in ARDS Secondary to COVID-19

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2020年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
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

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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