Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04818866
Acronym
ISIC
Enrollment
4463
Registered
2021-03-26
Start date
2020-02-01
Completion date
2022-12-01
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

SuPAR, CRP, D-dimer, Ferritin, Interleukin-6, Procalcitonin, lactate dehydrogenase, biomarkers

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.

Interventions

DIAGNOSTIC_TESTSuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate Dehydrogenase

Biomarkers of inflammation

Sponsors

Rush University
CollaboratorOTHER
Copenhagen University Hospital, Hvidovre
CollaboratorOTHER
University of Athens
CollaboratorOTHER
Heinrich-Heine University, Duesseldorf
CollaboratorOTHER
University of Thessaly
CollaboratorOTHER
Charite University, Berlin, Germany
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
In-hospital incidence of death, need for mechanical ventilation and need for renal replacement therapyduring COVID91 related hospitalization, up to 6 monthsComposite outcome of death, need for mechanical ventilation, need for renal replacement therapy

Secondary

MeasureTime frameDescription
Acute Kidney Injurywithin 6 monthsPer KDIGO criteria
Cardiovascular Eventswithin 6 monthsIn-hospital new diagnosis heart failure, arrhythmia, myocardial infarction
Length of Hospitalizationup to 6 monthsDuration of hospitalization
Need for renal replacement therapywithin 6 monthsIn-hospital renal replacement therapy or dialysis
Need for mechanical ventilationwithin 6 monthsRespiratory failure requiring mechanical ventilation
Deathwithin 6 monthsIn-hospital mortality

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026