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:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT05382234
Eligibility Criteria:
Inclusion Criteria:
Any suspected case of MIS-C from birth to 12 year included both sexes fulfill criteria of MIS-C (WHO) .
1. Fever for ≥3 days.
2. Clinical signs of multi system involvement (at least 2 of the following):
1. Rash, bilateral non purulent conjunctivitis, or mucocutaneou inflammation signs (oral, hands, or feet)
2. Hypotension or shock
3. Cardiac dysfunction, pericarditis, valvulitis , or coronary abnormalities (including echocardiographic findings or elevated troponin)
4. Evidence of coagulopathy (prolonged PT or PTT)
5. Acute gastrointestinal symptoms (diarrhea , vomiting, or abdominal pain)
4\. Elevated markers of inflammation (eg ESR, CRP) 5. No other obvious microbial cause of inflammation. 6. Evidence of SARS-CoV-2 infection (Any of the following: Positive SARS-CoV-2 RT-PCR ,positive serology, COVID 19 exposure within the 4 weeks prior to the onset of symptoms).
according to CDC criteria exposure to a patients with suspected or confirmed COVID-19 within the 4 weeks prior to the onset of symptoms.
Exclusion Criteria:
* Other obvious microbial cause of inflammation, including bacterial sepsis and staphylococcal/streptococcal toxic shock syndromes.
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
12 Years
Study:
NCT05382234
Study Brief:
Protocol Section:
NCT05382234