An observational study in Covid19, Outcome, Fatal and Respiratory Failure, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by University of Michigan · Observational
This is a prospective multi-center observational study which purpose is to evaluate the ability of blood-based inflammatory markers to risk-stratify patients hospitalized for Covid-19. Blood-based biomarkers examined include: soluble urokinase plasminogen activator receptor (suPAR), C-reactive protein (CRP), procalcitonin, D-dimer, ferritin, lactate dehydrogenase and interleukin-6.
All consecutive patients hospitalized specifically for Covid-19 at the University of Michigan in Ann Arbor from February 1st, 2020 to date are included. Other participating centers will enroll patients depending on their variable capacity. Patients with a positive test for SARS-CoV-2 but hospitalized for non-Covid-19 reasons were excluded. Blood-based biomarkers including soluble urokinase plasminogen activator receptor (suPAR), C-reactive protein (CRP), procalcitonin, D-dimer, ferritin, lactate dehydrogenase and interleukin-6 are measured in samples collected within 48 hours of presentation. The primary outcome of the study is the composite endpoint of in-hospital mortality, need for mechanical ventilation and need for renal replacement therapy.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 4,463 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients hospitalized primarily for Covid-19
Exclusion Criteria:
Diagnostic Test: SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate Dehydrogenase
Biomarkers of inflammation
In-hospital incidence of death, need for mechanical ventilation and need for renal replacement therapy
Composite outcome of death, need for mechanical ventilation, need for renal replacement therapy
Time frame: during COVID91 related hospitalization, up to 6 months
Length of Hospitalization
Duration of hospitalization
Time frame: up to 6 months
Acute Kidney Injury
Per KDIGO criteria
Time frame: within 6 months
Cardiovascular Events
In-hospital new diagnosis heart failure, arrhythmia, myocardial infarction
Time frame: within 6 months
Death
In-hospital mortality
Time frame: within 6 months
Need for renal replacement therapy
In-hospital renal replacement therapy or dialysis
Time frame: within 6 months
Need for mechanical ventilation
Respiratory failure requiring mechanical ventilation
Time frame: within 6 months
Plan to share: No — Due to consent waiver, individual participant data cannot be shared with investigators outside the University of Michigan
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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University of Michigan