ISIC: International Study of Inflammation in COVID-19

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04818866

Collaborator

Rush University (Other), Copenhagen University Hospital, Hvidovre (Other), University of Athens (Other), Heinrich-Heine University, Duesseldorf (Other), University of Thessaly (Other), Charite University, Berlin, Germany (Other)

2,500

Enrollment

Location

Anticipated Duration (Months)

54.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Outcome, Fatal Respiratory Failure Acute Kidney Injury Inflammation	Diagnostic Test: SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate Dehydrogenase

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 Design

Study Type:

Observational

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Patients hospitalized for Covid-19

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

Biomarkers of inflammation

Outcome Measures

Primary Outcome Measures

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

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