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临床试验/NCT04733105
NCT04733105已完成不适用

Pronostic Value of Type I ANTi-Interferon Antibodies in Patients With COVID-19 Acute Respiratory Failure: a Multicenter Observational Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 1,022 人开始时间: 2020年11月20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
1,022
试验地点
1
主要终点
day-28 mortality

研究概览

简要总结

Severe SARS-CoV-2 infections are frequently associated with the acute respiratory distress syndrome (ARDS), which leads to a mortality of 30-40%. An altered type I interferon (IFN) response has been demonstrated in patients with severe COVID-19, together with a high viral load.

The aim of the current work is, in a large cohort of patients with severe COVID-19 admitted in the ICU, to determine the prevalence of patients with positive anti-IFN antibodies and to determine their outcome, as compared to patients having negative anti-IFN antibodies.

详细描述

Severe SARS-CoV-2 infections are frequently associated with the acute respiratory distress syndrome (ARDS), which leads to a mortality of 30-40%. An altered type I interferon (IFN) response has been demonstrated in patients with severe COVID-19, together with a high viral load. A recent study revealed that 10% of patients admitted in the intensive care unit (ICU) for severe COVID-19 had positive type I anti-IFN antibodies. Such finding has potentially important therapeutic implications, as patients having positive anti-IFN antibodies could benefit from targeted interventions, including plasmapheresis. The aim of the current work is, in a large cohort of patients with severe COVID-19 admitted in the ICU, to determine the prevalence of patients with positive anti-IFN antibodies and to determine their outcome, as compared to patients having negative anti-IFN antibodies.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • Age ≥ 18 years
  • SARS-CoV-2 infection with a positive PCR
  • Patient admitted in the ICU for acute respiratory failure (SpO2≤90% and need for supplemental oxygen or any kind of ventilator support)
  • Patient or next of keen was informed of study inclusion

排除标准

  • Patient with SARS-CoV-infection but no acute respiratory failure

结局指标

主要结局

day-28 mortality

时间窗: at day-28 of intensive care unit (ICU) admission

comparaison of day-28 mortality in patients having positive versus negative type I anti-IFN antibodies

次要结局

  • rate of positivity of type I anti-IFN antibodies(3 months of ICU admission)
  • Factors associated with type I anti-IFN antibody positivity(24 hours of ICU admission)
  • hospital mortality(at day 90.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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