Covid19ISICNCT04818866

International Study of Inflammation in COVID-19

An observational study of Covid19 and Outcome, Fatal, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19, Outcome, Fatal, Respiratory Failure
What is being tested?: SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate Dehydrogenase
How many people: 4,463 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2020to 1 Dec 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients hospitalized primarily for Covid-19

Who may be able to join

Positive SARS-CoV-2 test result
Covid-19 as the primary reason for hospitalization

Who cannot join

Hospitalized primarily for non-Covid-19 reasons

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Covid19, Outcome, Fatal, Respiratory Failure, Acute Kidney Injury, Inflammation
Being tested: SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate Dehydrogenase
Keywords: SuPAR, CRP, D-dimer, Ferritin, Interleukin-6, Procalcitonin, lactate dehydrogenase, biomarkers
Medical subject headings: COVID-19, Respiratory Insufficiency, Acute Kidney Injury, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate DehydrogenaseDiagnostic test
Biomarkers of inflammation

Study groups in NCT04818866
Study group	Role	What they receive
Patients hospitalized for Covid-19		Not described Receives: Diagnostic Test: SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate Dehydrogenase

What is being measured

The primary outcome is the main question the study is designed to answer.

In-hospital incidence of death, need for mechanical ventilation and need for renal replacement therapy
Composite outcome of death, need for mechanical ventilation, need for renal replacement therapy
Measured: during COVID91 related hospitalization, up to 6 months

Secondary outcomes (6)

Length of Hospitalization
Duration of hospitalization
Measured: up to 6 months
Acute Kidney Injury
Per KDIGO criteria
Measured: within 6 months
Cardiovascular Events
In-hospital new diagnosis heart failure, arrhythmia, myocardial infarction
Measured: within 6 months
Death
In-hospital mortality
Measured: within 6 months
Need for renal replacement therapy
In-hospital renal replacement therapy or dialysis
Measured: within 6 months
Need for mechanical ventilation
Respiratory failure requiring mechanical ventilation
Measured: within 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20201 Dec 2022

First posted26 Mar 2021
Study start1 Feb 2020
Primary completion1 Dec 2022
Study completion1 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 4,463 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04818866
Sponsor's protocol ID: HUM00178971-a
Acronym: ISIC
Status last verified: Oct 2023
First submitted: 25 Mar 2021
Last updated: 31 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to consent waiver, individual participant data cannot be shared with investigators outside the University of Michigan

Publications

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.
PubMed 32354367
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.
PubMed 34793753
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.
PubMed 35045184
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.
PubMed 34889102
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.
PubMed 32963090
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.
PubMed 34501358
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.
PubMed 36193749
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.
PubMed 35924778
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.
PubMed 37729431
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.
PubMed 38391282

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04818866
Acronym / sponsor ID: ISIC / HUM00178971-a
Conditions: Covid19, Outcome, Fatal, Respiratory Failure, Acute Kidney Injury, Inflammation
Keywords: SuPAR, CRP, D-dimer, Ferritin, Interleukin-6, Procalcitonin, lactate dehydrogenase, biomarkers
Study type: Observational
Recruitment status: Completed
Enrolment: 4,463 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Rush University, Copenhagen University Hospital, Hvidovre, University of Athens, Heinrich-Heine University, Duesseldorf, University of Thessaly, Charite University, Berlin, Germany
Study start: 1 Feb 2020 (actual)
Primary completion: 1 Dec 2022 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 26 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients hospitalized primarily for Covid-19

Key inclusion criteria (2 listed)

Positive SARS-CoV-2 test result
Covid-19 as the primary reason for hospitalization

Key exclusion criteria (1 listed)

Hospitalized primarily for non-Covid-19 reasons

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate DehydrogenaseBiomarkers of inflammation	Diagnostic test	Patients hospitalized for Covid-19

Primary outcome

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

6 secondary outcomes

Length of Hospitalization
Time frame: up to 6 months
Acute Kidney Injury
Time frame: within 6 months
Cardiovascular Events
Time frame: within 6 months
Death
Time frame: within 6 months
Need for renal replacement therapy
Time frame: within 6 months
Need for mechanical ventilation
Time frame: within 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
Background: PubMed 32354367Rovina 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.
Background: PubMed 34793753Azam 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.
Background: PubMed 35045184Vasbinder 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.
Background: PubMed 34889102Pan 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.
Background: PubMed 32963090Azam 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.
Background: PubMed 34501358Hayek 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.
Background: PubMed 36193749Vasbinder 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.
Background: PubMed 35924778Luo 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.
Background: PubMed 37729431Zhu 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.
Derived from this study: PubMed 38391282Chalkias 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.
Individual participant dataSharing planned: No. Due to consent waiver, individual participant data cannot be shared with investigators outside the University of Michigan

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Salim S Hayek, MD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Outcome, Fatal, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04818866, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.