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NCT05334134 Clinical Trial

COVID-19: Immunological Mechanisms in Multisystem Inflammatory Syndrome in Children

COVID-19 Clinical Trial

Official title:
Immunological Mechanisms in Multisystem Inflammatory Syndrome in Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05334134
Other study ID # H-20028631_MIS-C_Immunology
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2020
Est. completion date June 30, 2023

Study information
Verified date April 2022
Source Rigshospitalet, Denmark
Contact Ulrikka Nygaard, MD PhD
Phone 40794656
Email Ulrikka@dadlnet.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study seeks to explore immunological mechanisms in patients with Multisystem Inflammatory Syndrome in Children (MIS-C) to improve the understanding of this pathogenesis of this disease. In a cohort of MIS-C patients diagnosed during the Wild type, Alpha, Delta and Omicron waves, research samples will be analyzed for whole-blood RNA expression, proteomics, inflammatory cytokines, cellular immune populations, autoantibodies, as well as host genetic markers.

Description:

BACKGROUND Multisystem inflammatory syndrome in children (MIS-C) is a rare severe complication to SARS-CoV-2 infection in children. Thousands of children worldwide have been hospitalized with this new disease. Yet, the immunological mechanisms are sparsely described. AIM The project seeks to explore immunological mechanisms in patients with MIS-C. METHOD From a prospective nationwide cohort of patients with MIS-C from Denmark (May 2020-March 2022), research samples will be investigated for whole-blood RNA expression, proteomics, inflammatory cytokines, metabolomics, cellular immune populations, autoantibodies, as well as host genetic markers allowing for detailed mapping this disease. Samples from MIS-C patients will be compared to patients with bacterial and viral disease, and other inflammatory diseases. TIME FRAME Sample identification: February 1 2022 to April 1, 2022. Sample analysis: April 1, 2022 to December 31, 2022 PERSPECTIVES New molecular-based tools may lead to improved understanding of the pathogenesis of MIS-C. This could form basis for development of novel diagnostic markers, identification of severe phenotype and therapeutic interventions.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Month to 17 Years
Eligibility Inclusion Criteria: - Patients diagnosed with MIS-C, according to the CDC criteria aged 0-17 years Exclusion Criteria: - Patients from whom patient/parent/legal guardian signed consent is not received

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Ulrikka Nygaard Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immunological mechanisms in MIS-C Whole-blood RNA expression at admission and change during recovery Day 0-3 and up to during 24 weeks
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