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Clinical Trial Summary

Multisystem inflammatory syndome in children (MIS-C) is a rare severe complication to SARS-CoV-2 infection in children. It has been reported to occur in approximately one of 3,000 to 4,000 unvaccinated children during the COVID-19 waves dominated by variant Alpha of SARS-CoV-2. However, the incidences following SARS-CoV-2 infection with variant Delta and Omikron, as well as among vaccinated children and adolescents with SARS-CoV-2 is yet unexplored. We aim to estimate the incidence of MIS-C in vaccinated and unvaccinated children and adolescents following variants Delta and Omicron based on a nationwide prospective population-based cohort study with detailed clinical phenotyping of MIS-C cases.


Clinical Trial Description

AIM The project seeks to estimate the incidences of MIS-C in vaccinated and unvaccinated children and adolescents following variants Delta and Omicron. HYPOTHESIS The incidences of MIS-C following SARS-CoV-2 variant Delta and Omicron are similar to the risk following variant Alpha in unvaccinated children and adolescents, while the incidences among vaccinated children and adolescents are significantly lower. METHOD Prospective nationwide population-based cohort study of all individuals aged 0-17 years hospitalized due to MIS-C in the period August 15, 2021 to August 14, 2022. The setting is a multicenter study including all 18 Danish Pediatric Departments, providing 24 hours emergency service, and in- and out-patient treatment for all Danish inhabitants aged ≤ 17 years. As part of a pediatric nationwide COVID-19 research set-up, all 18 departments have a principal investigator responsible for prospective real-time data collection of patients with MIS-C. To calculate the incidence of MIS-C among Danish children and adolescents, the number of individuals who has tested positive for a SARS-CoV-2 infection in the period July 15 2021 to July 14 2022 will be attained from the National COVID-19-vaccine Database at the Statens Serum Institut. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05186597
Study type Observational
Source Rigshospitalet, Denmark
Contact Ulrikka Nygaard
Phone 40794656
Email [email protected]
Status Recruiting
Phase
Start date July 15, 2021
Completion date December 31, 2022

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