Symphony IL-6 Study in Patients at Risk of Severe Sepsis Due to COVID-19 and/or Influenza Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who require invasive mechanical ventilation
研究概览
简要总结
Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment in a near patient setting.
This study is to establish an interleukin-6 (IL-6) cutoff value using the Symphony IL-6 test for patients at high risk of severe sepsis caused by a COVID-19 and/or influenza infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Whole-blood specimen collected in EDTA anticoagulant tube
- •Subject is 22+ years of age
- •A minimum volume of 0.3 ml blood will be collected for Symphony IL-6 testing
- •Subjects who have concurrently received CRP test results
- •Subject is confirmed to be COVID-19 positive by an EUA or FDA cleared SARS-CoV-2 positive RT-PCR test, and/or the subject is confirmed to be influenza-A or influenza-B positive by an FDA cleared test.
排除标准
- •Subject is receiving an anti-IL-6 treatment
- •Hemolyzed specimens
结局指标
主要结局
Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who require invasive mechanical ventilation
时间窗: Total duration of COVID-19 and/or influenza hospitalization, up to 1 year
Patients hospitalized with confirmed COVID-19 and/or influenza who require invasive mechanical ventilation due to complications with the infection.
次要结局
- Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who develop severe or critical illness(Total duration of the COVID-19 hospitalization, up to 1 year)
- Concentration of IL-6 in hospitalized patients with COVID-19 and/or Influenza who expire during hospital stay(Total duration of COVID-19 and/or influenza hospitalization, up to 1 year)