Status:
ACTIVE_NOT_RECRUITING
Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children
Lead Sponsor:
Carelon Research
Conditions:
Multisystem Inflammatory Syndrome in Children (MIS-C)
Eligibility:
All Genders
Up to 21 years
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 Ou...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- No plausible alternative diagnosis, such as bacterial sepsis, murine typhus, staphylococcal or streptococcal shock syndromes
Key Trial Info
Start Date :
September 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT05287412
Start Date
September 30 2020
End Date
December 31 2025
Last Update
February 12 2025
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama
Tuscaloosa, Alabama, United States, 35401
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
4
Valley Children's Healthcare and Hospital
Madera, California, United States, 93636