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Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children
Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children

NCT05287412

Active Not RecruitingN/A

Sponsor: Carelon Research

Conditions: Multisystem Inflammatory Syndrome in Children (MIS-C)

Countries: United States, Canada

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.

Eligibility overview

Sex: ALL

Age: — to 21 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

1. Age \<21 years.
2. Fever ≥38°C for ≥24 hours, or report of subjective fever lasting ≥24 hours.
3. 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.
4. 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.
5. 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

Exclusion Criteria:

* No plausible alternative diagnosis, such as bacterial sepsis, murine typhus, staphylococcal or streptococcal shock syndromes
Locations (33)
  • Tuscaloosa, Alabama, United States
  • Phoenix, Arizona, United States
  • Los Angeles, California, United States
  • Madera, California, United States
  • San Diego, California, United States
  • Aurora, Colorado, United States
  • Wilmington, Delaware, United States
  • Washington D.C., District of Columbia, United States
  • Hollywood, Florida, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • Jackson, Mississippi, United States
  • Kansas City, Missouri, United States
  • New York, New York, United States
  • Queens, New York, United States
  • Chapel Hill, North Carolina, United States
  • Durham, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • + 3 more on CT.gov