International Study of Inflammation in COVID-19 (ISIC)

October 27, 2023 updated by: Salim S. Hayek, University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4463

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients hospitalized primarily for Covid-19

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during COVID91 related hospitalization, up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

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

Investigators

  • Principal Investigator: Salim S Hayek, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00178971-a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to consent waiver, individual participant data cannot be shared with investigators outside the University of Michigan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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