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Study of immune markers in multisystem inflammatory syndrome in children (MIS-C)

Phase 4
Completed
Conditions
Health Condition 1: U071- COVID 19 virus identified
Registration Number
CTRI/2021/12/039054
Lead Sponsor
Indian Council of Medical Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

Study group:

Patients diagnosed to be MIS-C cases by the treating physicians and co-investigators at the three collaborating centres (Kasturba Medical College, Manipal; Kasturba Medical College, Mangalore and Ramaiah Medical College, Bangalore) as per the WHO case definition.

Control groups:

There will be three sub-groups in this:

A) SARS-CoV-2 RT PCR positive patients in the age group, 0 – 19, not fitting into the WHO case definition of MIS-C.

B) Age matched healthy controls who are negative for SARS-CoV-2 RT-PCR and do not have signs and symptoms of any ongoing infection.

C) Children were classified as having complete/incomplete Kawasaki Disease (KD) by using American Heart Association criteria

Exclusion Criteria

Subjects on immunomodulatory therapy for samples obtained following the first visit to the treating physician

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Plasma cytokines, sC5b-9 and anti SARS-CoV-2 IgG and neutralizing antibody levels along with clinical correlation may help diagnose and differentiate MIS-C from other conditions with overlapping clinical features like Kawasaki disease.Timepoint: At first visit and follow up after 1 month
Secondary Outcome Measures
NameTimeMethod
nderstand the pathophysiology of MIS-CTimepoint: At first visit and follow up after 1 month
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