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Multisystem Inflammatory Syndrome in Children (MIS-C)MUSICNCT05287412

Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children

An observational study of Multisystem Inflammatory Syndrome in Children (MIS-C), run by Carelon Research at 33 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Multi-system Inflammatory Syndrome in Children (MIS-C) is a new condition related to COVID-19, the study investigators are still learning about its causes, effects, and long-term impact. Read more about this study

Who is it for?
Ages Up to 21 years
How many people
1,200 participants
Where
33 sitesin 2 countries
Study dates
30 Sep 2020to 31 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: children and young adults <21 years with Multisystem Inflammatory Syndrome in Children associated with COVID-19 (MIS-C) at a participating hospital

Who may be able to join

  • Age <21 years.
  • Fever ≥38°C for ≥24 hours, or report of subjective fever lasting ≥24 hours.
  • Laboratory evidence of inflammation, including, but not limited to, one or more of the following: an elevated CRP, ESR, fibrinogen, procalcitonin, d-dimer, ferritin, LDH, or IL-6, elevated neutrophils, reduced lymphocytes and low albumin.
  • Evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement, based on clinical judgment from record review, discharge diagnosis, laboratory or diagnostic tests. Organ system involvement includes but is not limited to cardiac, renal, respiratory, hematologic including coagulopathy, gastrointestinal including liver, dermatologic or neurological.
  • Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test; or COVID-19 exposure within the 4 weeks prior to the onset of symptoms

Who cannot join

  • No plausible alternative diagnosis, such as bacterial sepsis, murine typhus, staphylococcal or streptococcal shock syndromes

Trial locations and contacts

33 sites in 2 countries.

33 sites in 2 countries

United States32 sites
  • CS Mott Children's Hospital/University of Michigan

    Ann Arbor, Michigan, 48109

  • Chldren's Healthcare of Atlanta

    Atlanta, Georgia, 30322

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045

  • Dell Medical Center

    Austin, Texas, 78707

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Ann & Robert Lurid Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Children's Medical Center of Dallas - UT Southwestern Medical Center

    Dallas, Texas, 75235

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Duke Children's Hospital and Health Center

    Durham, North Carolina, 27705

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Baylor /Texas Children's Hospital

    Houston, Texas, 77030

  • Riley Children's Hospital

    Indianapolis, Indiana, 46202

  • University of Mississippi

    Jackson, Mississippi, 39216

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Valley Children's Healthcare and Hospital

    Madera, California, 93636

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

  • Medical College of Wisconsin/Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70118

  • Morgan Stanley Children's Hospital of New York

    New York, New York, 10032

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • Cohen Children's Medical Center

    Queens, New York, 11040

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

  • UC San Diego, Rady Children's Hospital

    San Diego, California, 92131

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • University of Alabama

    Tuscaloosa, Alabama, 35401

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010

  • The Nemours Foundation

    Wilmington, Delaware, 19808

Other trials in United States

Canada1 site
  • The Hospital for Sick Children

    Toronto, Ontario

Other trials in Canada

About this study

Multi-system Inflammatory Syndrome in Children (MIS-C) is a new condition related to COVID-19, the study investigators are still learning about its causes, effects, and long-term impact. "Long-Term Outcomes after the Multisystem Inflammatory Syndrome In Children", the Coronavirus MUSIC Study, is a research study funded by NIH and the National Heart, Lung, and Blood Institute. The study investigators hope to enroll at least 900 young people with MIS-C at children's medical centers in the U.S. and Canada. This research study will help us learn more about MIS-C and its effects on the long-term health of children.

Read the detailed description

This study is an observational cohort study that will use routinely collected clinical and cardiac (EKG, echocardiogram, Cardiac MRI, exercise testing) data to assess the association between MIS-C and cardiac outcomes within the first year after hospital discharge. Research funding will be available for EKGs, echocardiograms and MRIs in protocol windows that are not ordered by primary caregivers. The principal goal is to determine the spectrum and early time course of coronary artery involvement, LV systolic function, and arrhythmias or conduction system abnormalities, and, using these data, to define associated clinical and laboratory factors. The study investigators planned to include all eligible patients, including retrospective cases beginning January 1, 2020, with follow-up (in-person or telehealth) to up within one year and annual medical history forms until up to 5 years have elapsed since illness onset. Because many patients will have been identified by retrospective review, the study team will obtain consent at different times in their illness course. For this reason, it may be hard to reach some patients and their families. Waiver of consent will be obtained after three attempts have been made to locate the patient and family without success, as well as for the rare child who dies before informed consent can be obtained. The study investigators will include a HIPAA-compliant cryptographic algorithm to create a sharable "hashed" identifier from patient information. If blood work for research purposes is added on to usual clinically indicated blood work during follow-up visits, this will be covered by other informed consent forms.

Keywords
COVID
Medical subject headings
pediatric multisystem inflammatory disease, COVID-19 related

What is being measured

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

  1. worst-ever LV ejection fraction

    worst left ventricular (LV) ejection fraction from core lab echo read during MUSIC study

    Measured: hospital admission through 5 years post-hospitalization

  2. worst-ever maximum z score of the proximal LAD or RCA

    worst maximum z-score of the proximal left anterior descending coronary artery (LAD) or right coronary artery (RCA) from core lab echo read; z-scores to be calculated via Boston z-score calculator (primary) and Pediatric Heart Network z-score calculator (secondary); higher z-scores are worse

    Measured: hospital admission through 5 years post-hospitalization

Secondary outcomes (34)
  1. Occurrence of a proximal LAD or RCA z score of ≥2.5 on any echocardiogram

    proximal left anterior descending coronary artery (LAD) or right coronary artery (RCA) ≥2.5 from any core lab echo read

    Measured: hospital admission through 5 years post-hospitalization

  2. Occurrence of aneurysms by Japanese Ministry of Health criteria

    Occurrence of aneurysms by Japanese Ministry of Health criteria applied to core lab echo reads

    Measured: hospital admission through 5 years post-hospitalization

  3. Individual z scores for LMCA, RCA and LAD

    Individual z scores for left main coronary artery (LMCA), right coronary artery (RCA) and proximal left anterior descending coronary artery (LAD) as per core lab echo reads; higher z-scores are worse

    Measured: hospital admission through 5 years post-hospitalization

  4. LVEDV z score

    left ventricular (LV) size as measured by left ventricular end-diastolic volume (LVEDV) z score

    Measured: hospital admission through 5 years post-hospitalization

  5. LVEF

    left ventricular (LV) function as measured by left ventricular ejection fraction (LVEF)

    Measured: hospital admission through 5 years post-hospitalization

  6. LVSF

    left ventricular (LV) function as measured by left ventricular shortening fraction (LVSF)

    Measured: hospital admission through 5 years post-hospitalization

  7. The percentage of patients who had LV ejection of <55%, and further categorization of 45-54% (i.e., mildly depressed systolic function), 35-44% (moderately depressed systolic function) and <35% (severely depressed systolic function) on any echocardiogram

    The percentage of patients who had left ventricular (LV) ejection of <55%, and further categorization of 45-54% (i.e., mildly depressed systolic function), 35-44% (moderately depressed systolic function) and <35% (severely depressed systolic function) on any echocardiogram read by the core lab

    Measured: hospital admission through 5 years post-hospitalization

  8. LV strain (global longitudinal strain from apical view and global circumferential strain from parasternal short-axis view)

    left ventricular (LV) strain (global longitudinal strain from apical view and global circumferential strain from parasternal short-axis view) on core lab echo read

    Measured: hospital admission through 5 years post-hospitalization

  9. Qualitative assessment of RV systolic function

    Qualitative assessment of right ventricular (RV) systolic function on core lab echo read

    Measured: hospital admission through 5 years post-hospitalization

  10. Qualitative assessment of RV global longitudinal strain

    Qualitative assessment, if possible, of right ventricular (RV) global longitudinal strain on core lab echo read

    Measured: hospital admission through 5 years post-hospitalization

  11. Presence and degree of mitral and aortic regurgitation

    Presence and degree of mitral and aortic regurgitation on echo core lab read

    Measured: hospital admission through 5 years post-hospitalization

  12. LV diastolic function, i.e., tissue Doppler imaging and mitral valve (MV) inflow

    left ventricular (LV) diastolic function, i.e., tissue Doppler imaging and mitral valve (MV) inflow on echo core lab read

    Measured: hospital admission through 5 years post-hospitalization

  13. Presence and size of pericardial effusion

    Presence and size of pericardial effusion on echo core lab read

    Measured: hospital admission through 5 years post-hospitalization

  14. The occurrence of arrhythmias and conduction system disturbances by in-hospital monitoring, electrocardiograms, and exercise testing at 3 months in those with a history of ≥moderate systolic dysfunction when age and maturity permit

    The occurrence of arrhythmias and conduction system disturbances by in-hospital monitoring, electrocardiograms, and exercise testing at 3 months in those with a history of ≥moderate systolic dysfunction when age and maturity permit

    Measured: 3 months post-discharge

  15. MRI LVEF

    LVEF on MRI core lab read

    Measured: hospital admission through 5 years post-hospitalization

  16. MRI RVEF

    RVEF on MRI core lab read

    Measured: hospital admission through 5 years post-hospitalization

  17. valvar regurgitation

    valvar regurgitation on MRI core lab read

    Measured: hospital admission through 5 years post-hospitalization

  18. myocardial late gadolinium enhancement (LGE)

    percent with and distribution of myocardial late gadolinium enhancement (LGE) on MRI core lab read

    Measured: hospital admission through 5 years post-hospitalization

  19. abnormal T2-weighted imaging

    percent abnormal T2-weighted imaging on MRI core lab read

    Measured: hospital admission through 5 years post-hospitalization

  20. elevated T2

    percent with elevated T2 on MRI core lab read

    Measured: hospital admission through 5 years post-hospitalization

  21. elevated native T1

    percent with elevated native T1 on MRI core lab read

    Measured: hospital admission through 5 years post-hospitalization

  22. elevated extracellular volume fraction

    percent with elevated extracellular volume fraction on MRI core lab read

    Measured: hospital admission through 5 years post-hospitalization

  23. coronary artery dilation

    percent with coronary artery dilation on MRI core lab read

    Measured: hospital admission through 5 years post-hospitalization

  24. CMR abnormal, equivocal, or negative

    final interpretation of CMR as abnormal, equivocal, or negative (i.e., no abnormal or equivocal findings) on MRI core lab read

    Measured: hospital admission through 5 years post-hospitalization

  25. Other organ abnormalities by medical history: Immunologic, rheumatologic, renal, pulmonary, hematologic, gastrointestinal, dermatologic or neurologic

    percent with other organ abnormalities by medical history: Immunologic, rheumatologic, renal, pulmonary, hematologic, gastrointestinal, dermatologic or neurologic

    Measured: hospital admission through 5 years post-hospitalization

  26. CRP

    C-Reactive Protein (CRP) as a laboratory marker of inflammation

    Measured: hospital admission through 5 years post-hospitalization

  27. Admission to ICU

    percent with admission to ICU

    Measured: hospital admission through 5 years post-hospitalization

  28. Maximal vasoactive inotrope score

    Maximal vasoactive inotrope score

    Measured: from MIS-C hospital admission to MIS-C hospital discharge

  29. Hospital length of stay

    Hospital length of stay

    Measured: from MIS-C hospital admission to MIS-C hospital discharge

  30. Symptom duration

    Symptom duration

    Measured: hospital admission through 5 years post-hospitalization

  31. Major medical events

    percent with major medical events (e.g., stroke, need for extracorporeal therapies such as renal replacement therapy, plasma exchange, ECMO, VAD)

    Measured: hospital admission through 5 years post-hospitalization

  32. Mortality

    Percent mortality

    Measured: hospital admission through 5 years post-hospitalization

  33. Global Health - FSS

    Global Health as measured by Functional Status Score [FSS]: range 6-30, lower is better

    Measured: hospital admission through 5 years post-hospitalization

  34. Global Health - PROMIS

    Global Health as measured by Parent-Reported Outcomes Measurement Information Systems [PROMIS] Instrument: range 7-35, higher is better

    Measured: hospital admission through 5 years post-hospitalization

Timeline

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

  1. First posted18 Mar 2022
  2. Study start30 Sep 2020
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05287412
Sponsor's protocol ID
G20479
Acronym
MUSIC
Status last verified
Mar 2026
First submitted
9 Feb 2022
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lang SM, Truong DT, Powell AJ, Kazlova V, Newburger JW, Awerbach JD, Binka E, Bradford TT, Cartoski M, Cheng A, DiLorenzo MP, Dionne A, Dorfman AL, Elias MD, Garuba O, Gerardin JF, Hasbani K, Jone PN, Lam CZ, Misra N, Morgan LM, Nutting A, Patel JK, Robinson JD, Schuchardt EL, Sexson Tejtel K, Singh GK, Slesnick TC, Trachtenberg F, Taylor MD; MUSIC Study Investigators. CMR Findings in the Long-Term Outcomes After Multisystem Inflammatory Syndrome in Children (MUSIC) Study. Circ Cardiovasc Imaging. 2025 Sep;18(9):e017420. doi: 10.1161/CIRCIMAGING.124.017420. Epub 2025 Apr 4.

    PubMed 40181776

Questions about this trial

What is this clinical trial studying?

An observational study of Multisystem Inflammatory Syndrome in Children (MIS-C), run by Carelon Research at 33 sites in 2 countries.

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 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Canada. 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?

This study is still under way. Results are not available in the source record yet.

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?

worst-ever LV ejection fraction (time frame: hospital admission through 5 years post-hospitalization). The study lists 2 primary outcomes in all. 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 NCT05287412, which also lists 1 linked publication.

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 27 Mar 2026.

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