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

Immunological Mechanisms in Multisystem Inflammatory Syndrome in Children

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05334134

Enrollment

300

Registered

2022-04-19

Start date

2020-02-01

Completion date

2023-06-30

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Multisystem Inflammatory Syndrome in Children, SARS-CoV-2 Infection

Keywords

Multisystem Inflammatory Syndrome in Children

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 17 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Denmark

Contacts

Primary ContactUlrikka Nygaard, MD PhD

Ulrikka@dadlnet.dk40794656

Outcome results