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

Completed

• Conditions: Inflammation; Covid19; Kidney Diseases; SARS-CoV Infection
• Interventions: Diagnostic Test: Biomarkers of inflammation

• Registration Number: NCT04706533
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-03-23
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3402

Inclusion Criteria

• Confirmed SARS-CoV-2 infection
• Hospitalized primarily for the treatment of COVID-19

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Exclusion Criteria

• SARS-CoV-2 positive but hospitalized for non-COVID-19 reasons

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covid-19	Biomarkers of inflammation	Patients with confirmed SARS-CoV-2 infection presenting specifically for Covid-19

Primary Outcome Measures

Name	Time	Method
Death, need for mechanical ventilation or need for dialysis	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States