The International Study of Inflammation in COVID-19: A Prospective Multi-Center Observational Study Examining the Role of Biomarkers of Inflammation in Predicting Covid-19 Related Outcomes in Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,463
- 试验地点
- 1
- 主要终点
- In-hospital incidence of death, need for mechanical ventilation and need for renal replacement therapy
研究概览
简要总结
This is a prospective multi-center observational study which purpose is to evaluate the ability of blood-based inflammatory markers to risk-stratify patients hospitalized for Covid-19. Blood-based biomarkers examined include: soluble urokinase plasminogen activator receptor (suPAR), C-reactive protein (CRP), procalcitonin, D-dimer, ferritin, lactate dehydrogenase and interleukin-6.
详细描述
All consecutive patients hospitalized specifically for Covid-19 at the University of Michigan in Ann Arbor from February 1st, 2020 to date are included. Other participating centers will enroll patients depending on their variable capacity. Patients with a positive test for SARS-CoV-2 but hospitalized for non-Covid-19 reasons were excluded. Blood-based biomarkers including soluble urokinase plasminogen activator receptor (suPAR), C-reactive protein (CRP), procalcitonin, D-dimer, ferritin, lactate dehydrogenase and interleukin-6 are measured in samples collected within 48 hours of presentation. The primary outcome of the study is the composite endpoint of in-hospital mortality, need for mechanical ventilation and need for renal replacement therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive SARS-CoV-2 test result
- •Covid-19 as the primary reason for hospitalization
排除标准
- •Hospitalized primarily for non-Covid-19 reasons
结局指标
主要结局
In-hospital incidence of death, need for mechanical ventilation and need for renal replacement therapy
时间窗: during COVID91 related hospitalization, up to 6 months
Composite outcome of death, need for mechanical ventilation, need for renal replacement therapy
次要结局
- Cardiovascular Events(within 6 months)
- Acute Kidney Injury(within 6 months)
- Death(within 6 months)
- Need for mechanical ventilation(within 6 months)
- Need for renal replacement therapy(within 6 months)
- Length of Hospitalization(up to 6 months)
研究者
Salim S. Hayek
Assistant Professor of Internal Medicine
University of Michigan