Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children

NCT05287412 | Active Not Recruiting DMC

• 1 other identifier: G20479
• Study Type: observational
• Target: 1,200
• Locations: 2 countries
• Sites: 33

Brief 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. "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.

Conditions

Multisystem Inflammatory Syndrome in Children (MIS-C)

Keywords

COVID

Outcome Measures

Primary Outcomes (2)

• worst-ever LV ejection fraction

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

  hospital admission through 5 years post-hospitalization

• 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

  hospital admission through 5 years post-hospitalization

Secondary Outcomes (34)

• Occurrence of a proximal LAD or RCA z score of ≥2.5 on any echocardiogram

  hospital admission through 5 years post-hospitalization

• Occurrence of aneurysms by Japanese Ministry of Health criteria

  hospital admission through 5 years post-hospitalization

• Individual z scores for LMCA, RCA and LAD

  hospital admission through 5 years post-hospitalization

• LVEDV z score

  hospital admission through 5 years post-hospitalization

• LVEF

  hospital admission through 5 years post-hospitalization

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Carelon Research: lead

Study Sites (33)

University of Alabama

Tuscaloosa, Alabama, 35401, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Valley Children's Healthcare and Hospital

Madera, California, 93636, United States

Location

UC San Diego, Rady Children's Hospital

San Diego, California, 92131, United States

Location

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

The Nemours Foundation

Wilmington, Delaware, 19808, United States

Location

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Chldren's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Ann & Robert Lurid Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

Location

Children's Hospital of New Orleans

New Orleans, Louisiana, 70118, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

CS Mott Children's Hospital/University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Morgan Stanley Children's Hospital of New York

New York, New York, 10032, United States

Location

Cohen Children's Medical Center

Queens, New York, 11040, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Duke Children's Hospital and Health Center

Durham, North Carolina, 27705, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Dell Medical Center

Austin, Texas, 78707, United States

Location

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

Dallas, Texas, 75235, United States

Location

Baylor /Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Medical College of Wisconsin/Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 40181776 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood or saliva that is collected for future whole genome sequencing will be requested as optional at any time that the patient is undergoing a clinical laboratory draw in participants who provide consent for this testing. To better understand the genetic variation within the heterogenous MIS-C population, blood or saliva samples from the biological parents of MIS-C patients will also be requested as optional. Samples from parents will also be stored at the similar venue for future whole genome sequencing. In addition, the study investigators expect to collaborate with centers or networks that are collecting research samples on these patients.

MeSH Terms

Conditions

pediatric multisystem inflammatory disease, COVID-19 related

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 18, 2022
• Study Start: September 30, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (32); CA (1)