NCT05334134

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

2.9 years

First QC Date

March 19, 2022

Last Update Submit

April 18, 2022

Conditions

Multisystem Inflammatory Syndrome in ChildrenCOVID-19SARS-CoV-2 Infection

Keywords

Multisystem Inflammatory Syndrome in Children

Outcome Measures

Primary Outcomes (1)

  • Immunological mechanisms in MIS-C

    Whole-blood RNA expression at admission and change during recovery

    Day 0-3 and up to during 24 weeks

Eligibility Criteria

Age1 Month - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients fulfilling the diagnostic critieria of MIS-C, according to the CDC

You may qualify if:

  • Patients diagnosed with MIS-C, according to the CDC criteria aged 0-17 years

You may not qualify if:

  • Patients from whom patient/parent/legal guardian signed consent is not received

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulrikka Nygaard

Copenhagen, 2100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

pediatric multisystem inflammatory disease, COVID-19 relatedCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ulrikka Nygaard, MD PhD

    Rigshospitalet, Denmark

    STUDY CHAIR

Central Study Contacts

Ulrikka Nygaard, MD PhD

CONTACT

40794656Ulrikka@dadlnet.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

March 19, 2022

First Posted

April 19, 2022

Study Start

February 1, 2020

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

April 19, 2022

Record last verified: 2022-04

Locations

DK(1)