Immun Response in Children With MIS-C

• Conditions: MIS-C Multisystem Inflammatory Syndrome in Children
• Interventions: Diagnostic Test: Analysis of cytokines and immun cell related markers

• Registration Number: NCT05052424
• Lead Sponsor: University of Cologne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-31
• Status Verified: 2021-09
• Study Start: 2021-09
• Study First Submitted QC: 2021-09-13
• Last Update Submitted: 2021-09-13
• Study First Posted: 2021-09-22
• Last Update Posted: 2021-09-22
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosed with MIS-C (WHO criteria)
• <18 years
• Hospitalized in the Children´s University Hospital of Cologne

Exclusion Criteria

• no informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with MIS-C	Analysis of cytokines and immun cell related markers	* 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.

Primary Outcome Measures

Name	Time	Method
Immune response in MIS-C	December 2022	.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.

Trial Locations

Locations (1)

University of Cologne, Medical Faculty; 🇩🇪 Cologne, Germany