Prospective Observational Study Examining Clinical Characteristics, Inflammatory Markers, Treatments and Outcomes of Patients Hospitalized for COVID-19 at the University of Michigan Healthcare System in Ann Arbor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,402
- 试验地点
- 1
- 主要终点
- Death, need for mechanical ventilation or need for dialysis
研究概览
简要总结
To better understand the role of inflammation in COVID-19, we established the Michigan Medicine COVID-19 Cohort (M2C2). M2C2 is a funded and ongoing cohort which has currently enrolled over 1500 adult patients (≥18 years) with severe COVID-19 admitted at the University of Michigan. The purpose of M2C2 is to define the in-hospital course of these patients and understand the role of inflammation as a determinant of organ injury and outcomes in COVID-19.
详细描述
The Michigan Medicine COVID-19 Cohort is a prospective observational cohort study of patients hospitalized specifically for COVID-19 at the University of Michigan Health System in Ann Arbor. Medical records of all consecutive patients with a positive SARS-CoV-2 are reviewed, and patients with confirmed SARS-CoV-2 infection but not primarily admitted for COVID-19 were excluded.
Biologic samples of patients enrolled in M2C2 were collected, and clinical characteristics including in-hospital outcomes were characterized in detail.
Biomarkers measured include, but not be limited to, soluble urokinase plasminogen activator receptor (suPAR), high sensitive C reactive protein (hs-CRP), brain natriuretic protein (BNP), high sensitive troponin T (hsTnT), interleukin 6 (IL-6), osteopontin, a2-antiplasmin.
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
- •Confirmed SARS-CoV-2 infection
- •Hospitalized primarily for the treatment of COVID-19
排除标准
- •SARS-CoV-2 positive but hospitalized for non-COVID-19 reasons
结局指标
主要结局
Death, need for mechanical ventilation or need for dialysis
时间窗: Total duration of the Covid-19 hospitalization, up to 1 year
The primary outcome is a composite endpoint, which is defined as the need for mechanical ventilation, the need for dialysis, or in-hospital death.
次要结局
- Need for dialysis(Total duration of the Covid-19 hospitalization, up to 1 year)
- All-cause death(Total duration of the Covid-19 hospitalization, up to 1 year)
- Need for mechanical ventilation(Total duration of the Covid-19 hospitalization, up to 1 year)
研究者
Salim S. Hayek
Assistant Professor of Internal Medicine
University of Michigan