Immun Response in Children With MIS-C

Study Overview
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Brief Summary
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Multi-system inflammatory syndrome in children (MIS-C) is a post-viral inflammatory vasculopathy of children and adolescents following Covid-19 infection. It affects one of 1000-5000 children. Latency between mild or asymptomatic Covid-19 infection and MIS-C is 4-6 weeks. The immune response in MIS-C seems to be dysregulated and different from that during acute SARS-CoV-2 infection. The investigators are planning to investigate the immune response in children with MIS-C. RNA and protein expression of cytokines and immune cell-related markers will be determined via multiplex ELISA, FACS, quantitative PCR, RNAseq, and Western blot. The use of highly sensitive multiplex methods will allow for the analysis of a large number of parameters in the smallest possible amount of sample. Sample preparation and analysis will be performed in close collaboration with the Centre for Molecular Medicine Cologne (CMMC) and the Institute of Virology. With this project the investigators hope to identify risk factors for developing MIS-C and extend the knowledge on therapeutic options for the treatment of this condition.

Official Title
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Cellular and Molecular Characterization of the Immune Response in Children and Adolescents With Inflammatory Syndrome in Children (MIS-C)

Conditions
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MIS-C Multisystem Inflammatory Syndrome in Children

Intervention / Treatment
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* Diagnostic Test: Analysis of cytokines and immun cell related markers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with MIS-C (WHO criteria) <18 years Hospitalized in the Children´s University Hospital of Cologne Exclusion Criteria: no informed consent

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with MIS-C<br>Children (age <18 years) hospitalized in the Children´s University Hospital of Cologne diagnosed with MIS-C (WHO criteria) Assessment of clinical data Blood samples are taken before therapy and on days 1,2,5,7 und 9. RNA and protein expression of cytokines and immune cell-related markers will be determined via multiplex ELISA, FACS, quantitative PCR, RNAseq, and Western blot. | Diagnostic Test: Analysis of cytokines and immun cell related markers<br>* blood samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response in MIS-C | .The primary outcome measure is a complex pattern of numerous molecular markers of immune response determined via multiplex ELISA, FACS, quantitative PCR, RNAseq. and Western Blot. For each child, this specific molecular immune response pattern will be determined and correlated with clinical determinants allowing for the identification of predictive factors and molecular markers useful for the management of future patients. | December 2022 |