Immun Response in Children With MIS-C

NCT05052424 | Unknown

• 1 other identifier: 21-1384
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

MIS-C Multisystem Inflammatory Syndrome in Children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Children with MIS-C

* 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

Interventions

Analysis of cytokines and immun cell related markers DIAGNOSTIC_TEST

blood samples

Children with MIS-C

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children with MIS-C

You may qualify if:

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

You may not qualify if:

• no informed consent

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University of Cologne, Medical Faculty

Cologne, 50937, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

pediatric multisystem inflammatory disease, COVID-19 related

Central Study Contacts

Katrin Mehler, MD

CONTACT

0049221478; Katrin.Mehler@uk-koeln.de

Andre Oberthuer, MD

CONTACT

0049221478; Andre.Oberthuer@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Katrin Mehler, Associate Professor

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 22, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

DE (1)