International Study of Inflammation in COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Covid19, Outcome, Fatal, Respiratory Failure, Acute Kidney Injury, Inflammation

Intervention / Treatment
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* Diagnostic Test: SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate Dehydrogenase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients hospitalized for Covid-19<br> | Diagnostic Test: SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate Dehydrogenase<br>* Biomarkers of inflammation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | during COVID91 related hospitalization, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospitalization | Duration of hospitalization | up to 6 months | 
| Acute Kidney Injury | Per KDIGO criteria | within 6 months | 
| Cardiovascular Events | In-hospital new diagnosis heart failure, arrhythmia, myocardial infarction | within 6 months | 
| Death | In-hospital mortality | within 6 months | 
| Need for renal replacement therapy | In-hospital renal replacement therapy or dialysis | within 6 months | 
| Need for mechanical ventilation | Respiratory failure requiring mechanical ventilation | within 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRP, SuPAR, D-dimer, Ferritin, Interleukin-6, Procalcitonin, lactate dehydrogenase, biomarkers