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Completed

NCT Number: NCT04818866

International Study of Inflammation in COVID-19

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.

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Key information

Conditions

Covid19 Acute Kidney Injury COVID-19 Coronaviridae Infections Coronavirus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Lung Diseases Male Urogenital Diseases Nidovirales Infections Outcome, Fatal Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Renal Insufficiency Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

Biomarkers of inflammation

Primary outcomes

  1. In-hospital incidence of death, need for mechanical ventilation and need for renal replacement therapy

    Time frame: during COVID91 related hospitalization, up to 6 months

    Composite outcome of death, need for mechanical ventilation, need for renal replacement therapy

Secondary outcomes

  1. Length of Hospitalization

    Time frame: up to 6 months

    Duration of hospitalization

  2. Acute Kidney Injury

    Time frame: within 6 months

    Per KDIGO criteria

  3. Cardiovascular Events

    Time frame: within 6 months

    In-hospital new diagnosis heart failure, arrhythmia, myocardial infarction

  4. Death

    Time frame: within 6 months

    In-hospital mortality

  5. Need for renal replacement therapy

    Time frame: within 6 months

    In-hospital renal replacement therapy or dialysis

  6. Need for mechanical ventilation

    Time frame: within 6 months

    Respiratory failure requiring mechanical ventilation

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study 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

Acronym: ISIC

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 26, 2021
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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