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
|Condition or disease||Intervention/treatment|
|Covid19 Kidney Diseases Inflammation SARS-CoV Infection||Diagnostic Test: Biomarkers of inflammation|
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|
|Estimated Enrollment :||2000 participants|
|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|
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
- 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.
- All-cause death [ Time Frame: 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 ]
- Need for dialysis [ Time Frame: Total duration of the Covid-19 hospitalization, up to 1 year ]
- Length of hospitalization [ Time Frame: Total duration of the Covid-19 hospitalization, up to 1 year ]
Biospecimen Retention: Samples Without DNA
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
|Contact: Salim Hayek, MDemail@example.com|
|Contact: Penney Kunklefirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Pennelope K Kunkle 734-936-3500 email@example.com|
|Principal Investigator: Salim S Hayek, MD|
|Principal Investigator:||Salim Hayek, MD||University of Michigan|