An observational study in MIS-C Multisystem Inflammatory Syndrome in Children, sponsored by University of Cologne. Status unknown at 1 site in Germany. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by University of Cologne · Observational
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.
9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.
This study's planned enrollment of 20 is below the median of 102 across 2,209 observational studies indexed under Syndrome.
Browse Syndrome studies →University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.
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Children with MIS-C
Exclusion Criteria:
* 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
blood samples
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.
Time frame: December 2022
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University of Cologne