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International Study of Inflammation in COVID-19 (ISIC)

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Inflammation
Respiratory Failure
Acute Kidney Injury
Covid19
Outcome, Fatal

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT04818866
HUM00178971-a

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,463 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

4,463 participants in 1 patient group

Patients hospitalized for Covid-19
Treatment:
Diagnostic Test: SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate Dehydrogenase

Trial contacts and locations

1

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Central trial contact

Salim S Hayek, MD; Pennelope K Kunkle

Data sourced from clinicaltrials.gov

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