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Immun Response in Children With MIS-C

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05052424
Enrollment
20
Registered
2021-09-22
Start date
2021-09-30
Completion date
2022-12-31
Last updated
2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MIS-C Multisystem Inflammatory Syndrome in Children

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.

Interventions

DIAGNOSTIC_TESTAnalysis of cytokines and immun cell related markers

blood samples

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* no informed consent

Design outcomes

Primary

MeasureTime frameDescription
Immune response in MIS-CDecember 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.

Countries

Germany

Contacts

Primary ContactKatrin Mehler, MD
Katrin.Mehler@uk-koeln.de0049221478
Backup ContactAndre Oberthuer, MD
Andre.Oberthuer@uk-koeln.de0049221478

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026