International Study of Inflammation in COVID-19

NCT ID: NCT04818866

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4463 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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.

Conditions

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Covid19 Outcome, Fatal Respiratory Failure Acute Kidney Injury Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients hospitalized for Covid-19

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

Intervention Type DIAGNOSTIC_TEST

Biomarkers of inflammation

Interventions

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

Biomarkers of inflammation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University

OTHER

Sponsor Role collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role collaborator

University of Athens

OTHER

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

University of Thessaly

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Salim S. Hayek

Assistant Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salim S Hayek, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Rovina N, Akinosoglou K, Eugen-Olsen J, Hayek S, Reiser J, Giamarellos-Bourboulis EJ. Soluble urokinase plasminogen activator receptor (suPAR) as an early predictor of severe respiratory failure in patients with COVID-19 pneumonia. Crit Care. 2020 Apr 30;24(1):187. doi: 10.1186/s13054-020-02897-4. No abstract available.

Reference Type BACKGROUND
PMID: 32354367 (View on PubMed)

Azam TU, Berlin H, Anderson E, Pan M, Shadid HR, Padalia K, O'Hayer P, Meloche C, Feroze R, Michaud E, Launius C, Blakely P, Bitar A, Willer C, Pop-Busui R, Carethers JM, Hayek SS. Differences in Inflammation, Treatment, and Outcomes Between Black and Non-Black Patients Hospitalized for COVID-19: A Prospective Cohort Study. Am J Med. 2022 Mar;135(3):360-368. doi: 10.1016/j.amjmed.2021.10.026. Epub 2021 Nov 16.

Reference Type BACKGROUND
PMID: 34793753 (View on PubMed)

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. 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.

Reference Type BACKGROUND
PMID: 35045184 (View on PubMed)

Pan M, Vasbinder A, Anderson E, Catalan T, Shadid HR, Berlin H, Padalia K, O'Hayer P, Meloche C, Azam TU, Khaleel I, Michaud E, Blakely P, Bitar A, Huang Y, Zhao L, Pop-Busui R, Loosen SH, Chalkias A, Tacke F, Giamarellos-Bourboulis EJ, Reiser J, Eugen-Olsen J, Hayek SS; ISIC Group. Angiotensin-Converting Enzyme Inhibitors, Angiotensin II Receptor Blockers, and Outcomes in Patients Hospitalized for COVID-19. J Am Heart Assoc. 2021 Dec 21;10(24):e023535. doi: 10.1161/JAHA.121.023535. Epub 2021 Dec 10.

Reference Type BACKGROUND
PMID: 34889102 (View on PubMed)

Azam TU, Shadid HR, Blakely P, O'Hayer P, Berlin H, Pan M, Zhao P, Zhao L, Pennathur S, Pop-Busui R, Altintas I, Tingleff J, Stauning MA, Andersen O, Adami ME, Solomonidi N, Tsilika M, Tober-Lau P, Arnaoutoglou E, Keitel V, Tacke F, Chalkias A, Loosen SH, Giamarellos-Bourboulis EJ, Eugen-Olsen J, Reiser J, Hayek SS; International Study of Inflammation in COVID-19. Soluble Urokinase Receptor (SuPAR) in COVID-19-Related AKI. J Am Soc Nephrol. 2020 Nov;31(11):2725-2735. doi: 10.1681/ASN.2020060829. Epub 2020 Sep 22.

Reference Type BACKGROUND
PMID: 32963090 (View on PubMed)

Hayek SS, Roderburg C, Blakely P, Launius C, Eugen-Olsen J, Tacke F, Ktena S, Keitel V, Luedde M, Giamarellos-Bourboulis EJ, Luedde T, Loosen SH. Circulating Osteopontin Levels and Outcomes in Patients Hospitalized for COVID-19. J Clin Med. 2021 Aug 30;10(17):3907. doi: 10.3390/jcm10173907.

Reference Type BACKGROUND
PMID: 34501358 (View on PubMed)

Vasbinder A, Meloche C, Azam TU, Anderson E, Catalan T, Shadid H, Berlin H, Pan M, O'Hayer P, Padalia K, Blakely P, Khaleel I, Michaud E, Huang Y, Zhao L, Pop-Busui R, Gupta S, Eagle K, Leaf DE, Hayek SS; STOP-COVID Investigatorsdouble dagger. Relationship Between Preexisting Cardiovascular Disease and Death and Cardiovascular Outcomes in Critically Ill Patients With COVID-19. Circ Cardiovasc Qual Outcomes. 2022 Oct;15(10):e008942. doi: 10.1161/CIRCOUTCOMES.122.008942. Epub 2022 Oct 4.

Reference Type BACKGROUND
PMID: 36193749 (View on PubMed)

Luo S, Vasbinder A, Du-Fay-de-Lavallaz JM, Gomez JMD, Suboc T, Anderson E, Tekumulla A, Shadid H, Berlin H, Pan M, Azam TU, Khaleel I, Padalia K, Meloche C, O'Hayer P, Catalan T, Blakely P, Launius C, Amadi KM, Pop-Busui R, Loosen SH, Chalkias A, Tacke F, Giamarellos-Bourboulis EJ, Altintas I, Eugen-Olsen J, Williams KA, Volgman AS, Reiser J, Hayek SS; ISIC (International Study of Inflammation in COVID-19) Group. Soluble Urokinase Plasminogen Activator Receptor and Venous Thromboembolism in COVID-19. J Am Heart Assoc. 2022 Sep 20;11(18):e025198. doi: 10.1161/JAHA.122.025198. Epub 2022 Aug 4.

Reference Type BACKGROUND
PMID: 35924778 (View on PubMed)

Zhu K, Mukherjee K, Wei C, Hayek SS, Collins A, Gu C, Corapi K, Altintas MM, Wang Y, Waikar SS, Bianco AC, Koch A, Tacke F, Reiser J, Sever S. The D2D3 form of uPAR acts as an immunotoxin and may cause diabetes and kidney disease. Sci Transl Med. 2023 Sep 20;15(714):eabq6492. doi: 10.1126/scitranslmed.abq6492. Epub 2023 Sep 20.

Reference Type BACKGROUND
PMID: 37729431 (View on PubMed)

Chalkias A, Huang Y, Ismail A, Pantazopoulos I, Papagiannakis N, Bitterman B, Anderson E, Catalan T, Erne GK, Tilley CR, Alaka A, Amadi KM, Presswalla F, Blakely P, Bernal-Morell E, Cebreiros Lopez I, Eugen-Olsen J, Garcia de Guadiana Romualdo L, Giamarellos-Bourboulis EJ, Loosen SH, Reiser J, Tacke F, Skoulakis A, Laou E, Banerjee M, Pop-Busui R, Hayek SS; International Study of Inflammation in COVID-19 (ISIC) Investigator Group. Intubation Decision Based on Illness Severity and Mortality in COVID-19: An International Study. Crit Care Med. 2024 Jun 1;52(6):930-941. doi: 10.1097/CCM.0000000000006229. Epub 2024 Feb 23.

Reference Type DERIVED
PMID: 38391282 (View on PubMed)

Other Identifiers

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HUM00178971-a

Identifier Type: -

Identifier Source: org_study_id

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