Michigan Medicine COVID-19 Cohort: Clinical Characteristics, Inflammatory Markers and Outcomes of Patients Hospitalized for COVID-19 (M2C2)

October 27, 2023 updated by: Salim S. Hayek, University of Michigan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3402

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults (>18 years) presenting or transferred to the University of Michigan Health System in Ann Arbor

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid-19
Patients with confirmed SARS-CoV-2 infection presenting specifically for Covid-19
Diagnostic test: Biomarkers of inflammation
Biomarkers were measured on blood samples collected within 48 hours of admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Total duration of the Covid-19 hospitalization, up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause death
Time Frame: Total duration of the Covid-19 hospitalization, up to 1 year
Total duration of the Covid-19 hospitalization, up to 1 year
Need for mechanical ventilation
Time Frame: Total duration of the Covid-19 hospitalization, up to 1 year
Total duration of the Covid-19 hospitalization, up to 1 year
Need for dialysis
Time Frame: Total duration of the Covid-19 hospitalization, up to 1 year
Total duration of the Covid-19 hospitalization, up to 1 year

Other Outcome Measures

Outcome Measure
Time Frame
Length of hospitalization
Time Frame: Total duration of the Covid-19 hospitalization, up to 1 year
Total duration of the Covid-19 hospitalization, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Salim Hayek, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2020

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00178971

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data cannot be shared due to consent waiver. Aggregate data and applications for ancillary studies are however available through contacting the Principal Investigator and a application process.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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