NCT04818866

International Study of Inflammation in COVID-19

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,463 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate Dehydrogenase	Biomarkers of inflammation

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2021-03-26
• Last updated: 2023-10-31

Locations

1 site across 1 country: United States