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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT05334134
Collaborator
(none)
300
Enrollment
1
Location
40.9
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Immunological Mechanisms in Multisystem Inflammatory Syndrome in Children
    Actual Study Start Date :
    Feb 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Jun 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Immunological mechanisms in MIS-C [Day 0-3 and up to during 24 weeks]

      Whole-blood RNA expression at admission and change during recovery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ulrikka Nygaard Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    • Study Chair: Ulrikka Nygaard, MD PhD, Rigshospitalet, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ulrikka Nygaard, Primary Investigator, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT05334134
    Other Study ID Numbers:
    • H-20028631_MIS-C_Immunology
    First Posted:
    Apr 19, 2022
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ulrikka Nygaard, Primary Investigator, Rigshospitalet, Denmark
    Multisystem Inflammatory Syndrome in Children
    Additional relevant MeSH terms:
    COVID-19
    Syndrome

    Study Results

    No Results Posted as of Apr 19, 2022