Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT04538495
Eligibility Criteria:
Inclusion criteria:
The following patients (age 1 mos. through young adults) will be recruited for this study:
Patients who meet the CDC definition for MIS-C:
* Patients presenting with fever (\>38C for \>24 h - also by subjective report), laboratory evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (\>2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological); AND
* No alternative plausible diagnoses; AND Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test; or suspected COVID-19 exposure within the 4 weeks prior to the onset of symptoms
* Patients who meet the CDC definition for MIS-C and require care in the PICU
Exclusion Criteria:
• All patients with pre-existing major medical conditions will be excluded. This includes patients with known genetic disorders (e.g. trisomy 21, cystic fibrosis), conditions requiring continuous medication (e.g. seizure disorder, heart disease), or known immune disorder (e.g. hypogammaglobulinemia, complement deficiency). Patients with asthma or atopic dermatitis will not be excluded unless patients have received oral steroids in the previous week. Obesity is not an exclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Study:
NCT04538495
Study Brief:
Protocol Section:
NCT04538495