International Study of Inflammation in COVID-19

Completed

• Conditions: Covid19; Outcome, Fatal; Acute Kidney Injury; Inflammation; Respiratory Failure

• Registration Number: NCT04818866
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4463

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital incidence of death, need for mechanical ventilation and need for renal replacement therapy	during COVID91 related hospitalization, up to 6 months	Composite outcome of death, need for mechanical ventilation, need for renal replacement therapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States