The International Study of Inflammation in COVID-19: A Prospective Multi-Center Observational Study Examining the Role of Biomarkers of Inflammation in Predicting Covid-19 Related Outcomes in Hospitalized Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- University of Michigan
- Enrollment
- 4463
- Locations
- 1
- Primary Endpoint
- In-hospital incidence of death, need for mechanical ventilation and need for renal replacement therapy
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Salim S. Hayek
Assistant Professor of Internal Medicine
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •Positive SARS-CoV-2 test result
- •Covid-19 as the primary reason for hospitalization
Exclusion Criteria
- •Hospitalized primarily for non-Covid-19 reasons
Outcomes
Primary Outcomes
In-hospital incidence of death, need for mechanical ventilation and need for renal replacement therapy
Time Frame: during COVID91 related hospitalization, up to 6 months
Composite outcome of death, need for mechanical ventilation, need for renal replacement therapy
Secondary Outcomes
- Cardiovascular Events(within 6 months)
- Acute Kidney Injury(within 6 months)
- Death(within 6 months)
- Need for mechanical ventilation(within 6 months)
- Need for renal replacement therapy(within 6 months)
- Length of Hospitalization(up to 6 months)