International Study of Inflammation in COVID-19

University of Michigan4,463 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

4,463

Conditions

Covid19 Outcome, Fatal Respiratory Failure Acute Kidney Injury Inflammation

Interventions

SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate DehydrogenaseDIAGNOSTIC_TEST

Biomarkers of inflammation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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