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

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ClinicalTrials.gov Identifier: NCT04706533
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Salim S. Hayek, 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.

Condition or disease Intervention/treatment
Covid19 Kidney Diseases Inflammation SARS-CoV Infection Diagnostic Test: Biomarkers of inflammation

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. All-cause death [ Time Frame: Total duration of the Covid-19 hospitalization, up to 1 year ]
  2. Need for mechanical ventilation [ Time Frame: Total duration of the Covid-19 hospitalization, up to 1 year ]
  3. Need for dialysis [ Time Frame: Total duration of the Covid-19 hospitalization, up to 1 year ]

Other Outcome Measures:
  1. Length of hospitalization [ Time Frame: Total duration of the Covid-19 hospitalization, up to 1 year ]

Biospecimen Retention:   Samples Without DNA
Plasma, serum and urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706533


Contacts
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Contact: Salim Hayek, MD 734-936-3500 shayek@umich.edu
Contact: Penney Kunkle penegonz@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Pennelope K Kunkle    734-936-3500    penegonz@umich.edu   
Principal Investigator: Salim S Hayek, MD         
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Salim Hayek, MD University of Michigan
Additional Information:
Publications:

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Responsible Party: Salim S. Hayek, Assistant Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT04706533    
Other Study ID Numbers: HUM00178971
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with interested parties who submit a written request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salim S. Hayek, University of Michigan:
Biomarkers
Outcomes
Inflammation
suPAR
C-reactive protein
Interleukin-6
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Kidney Diseases
Inflammation
Pathologic Processes
Urologic Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases