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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- University of Michigan
- Enrollment
- 3402
- Locations
- 1
- Primary Endpoint
- Death, need for mechanical ventilation or need for dialysis
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Salim S. Hayek
Assistant Professor of Internal Medicine
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •Confirmed SARS-CoV-2 infection
- •Hospitalized primarily for the treatment of COVID-19
Exclusion Criteria
- •SARS-CoV-2 positive but hospitalized for non-COVID-19 reasons
Outcomes
Primary Outcomes
Death, need for mechanical ventilation or need for dialysis
Time Frame: 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.
Secondary Outcomes
- 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)