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International Study of Inflammation in COVID-19 (ISIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04818866
Recruitment Status : Active, not recruiting
First Posted : March 26, 2021
Last Update Posted : October 12, 2021
Sponsor:
Collaborators:
Rush University
Copenhagen University Hospital, Hvidovre
University of Athens
Heinrich-Heine University, Duesseldorf
University of Thessaly
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Salim S. Hayek, University of Michigan

Study Description
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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
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
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Study Type : Observational
Estimated 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 : February 1, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Plasma or serum samples collected within 48 hours of presentation.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients hospitalized primarily for Covid-19
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04818866


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Rush University
Copenhagen University Hospital, Hvidovre
University of Athens
Heinrich-Heine University, Duesseldorf
University of Thessaly
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Salim S Hayek, MD University of Michigan
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Vasbinder A, Anderson E, Shadid H, Berlin H, Pan M, Azam TU, Khaleel I, Padalia K, Meloche C, O'Hayer P, Michaud E, Catalan T, Feroze R, Blakely P, Launius C, Huang Y, Zhao L, Ang L, Mikhael M, Mizokami-Stout K, Pennathur S, Kretzler M, Loosen SH, Chalkias A, Tacke F, Giamarellos-Bourboulis EJ, Reiser J, Eugen-Olsen J, Feldman EL, Pop-Busui R, Hayek SS; ISIC Study Group:, Hayek SS, Blakely P, Berlin H, Azam TU, Shadid H, Pan M, O'Hayer P, Meloche C, Feroze R, Padalia KJ, Anderson E, Perry D, Bitar A, Kaakati R, Huang Y, Zhao L, Reiser J, Samelko B, Hlepas A, Patel PP, Wang X, Eugen-Olsen J, Altintas I, Stauning M, Baltzer Houlind M, Lindstrøm MB, Gamst-Jensen H, Hartmann LJ, Nehlin JO, Kallemose T, Parvaiz I, Rasmussen C, Andersen O, Tingleff J, Giamarellos-Bourboulis EJ, Adami ME, Solomonidi N, Tsilika M, Saridaki M, Lekakis V, Loosen SH, Luedde T, Keitel V, Chalkias A, Arnaoutoglou E, Pantazopoulos I, Laou E, Kolonia K, Skoulakis A, Tacke F, Tober-Lau P, Mohr R, Kurth F, Sander LE, Jochum C. Inflammation, Hyperglycemia, and Adverse Outcomes in Individuals With Diabetes Mellitus Hospitalized for COVID-19. Diabetes Care. 2022 Mar 1;45(3):692-700. doi: 10.2337/dc21-2102.

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Responsible Party: Salim S. Hayek, Assistant Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT04818866    
Other Study ID Numbers: HUM00178971-a
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to consent waiver, individual participant data cannot be shared with investigators outside the University of Michigan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salim S. Hayek, University of Michigan:
SuPAR
CRP
D-dimer
Ferritin
 Interleukin-6
Procalcitonin
lactate dehydrogenase
biomarkers
Additional relevant MeSH terms:
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COVID-19
Respiratory Insufficiency
Acute Kidney Injury
Inflammation
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Respiration Disorders
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants