Michigan Medicine COVID-19 Cohort: Clinical Characteristics, Inflammatory Markers and Outcomes of Patients Hospitalized for COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Covid19, Kidney Diseases, Inflammation, SARS-CoV Infection

Intervention / Treatment
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* Diagnostic Test: Biomarkers of inflammation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid-19<br>Patients with confirmed SARS-CoV-2 infection presenting specifically for Covid-19 | Diagnostic Test: Biomarkers of inflammation<br>* Biomarkers were measured on blood samples collected within 48 hours of admission<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, need for mechanical ventilation or need for dialysis | The primary outcome is a composite endpoint, which is defined as the need for mechanical ventilation, the need for dialysis, or in-hospital death. | Total duration of the Covid-19 hospitalization, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Need for dialysis |  | Total duration of the Covid-19 hospitalization, up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers, Outcomes, Inflammation, suPAR, C-reactive protein, Interleukin-6