Immun Response in Children With MIS-C

September 13, 2021 updated by: Katrin Mehler, University of Cologne

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Cologne, Germany, 50937
        • University of Cologne, Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with MIS-C

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune response in MIS-C
Time Frame: 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.
December 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-1384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on MIS-C Multisystem Inflammatory Syndrome in Children

Clinical Trials on Analysis of cytokines and immun cell related markers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe