Clinical trial NCT05186597: Incidence of MIS-C and Other Complications Following SARS-CoV-2 Infection
Official title: Incidence of Multisystem Inflammatory Syndrome in Children (MIS-C) and Other Complications Following SARS-CoV-2. A Nationwide Population-based Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS CoV 2 Infection
Multisystem Inflammatory Disease, Pediatric, COVID-19 Related
Multisystem Inflammatory Syndrome in Children
COVID-19 Pandemic
Keywords: SARS CoV 2 Infection
Multisystem Inflammatory Syndrome in Children
COVID-19 Pandemic
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
name: Ministry of Education, Denmark
First posted: 2022-01-11
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children and adolescents in the whole population of Denmark

Brief summary: Multisystem inflammatory syndrome 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 omicron, as well as among vaccinated children and adolescents with SARS-CoV-2 is yet unexplored.

The investigators aim to estimate the incidence of MIS-C and in vaccinated and unvaccinated children and adolescents following variants delta and omicron, and other complications of SARS-CoV-2 including complication due to SARS-CoV-2 lock-down, based on a nationwide prospective population-based cohort study.

Detailed description: AIM The project seeks to estimate the incidences of MIS-C in vaccinated and unvaccinated children and adolescents following variants delta and omicron, and other complications of SARS-CoV-2 including complication due to SARS-CoV-2 lock-down, .

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. Further, severe complications to SARS-CoV-2, e.g. PVL producing S aur. infection is increased, as well as severe RSV-complication in older children in the post-COVID-lock down RSV epidemic

METHOD Prospective nationwide population-based cohort study of all individuals aged 0-17 years hospitalized due to MIS-C, or other complications to SARS-CoV-2 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 and other complications to SARS-CoV-2, including complications secondary to the lock-down.

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. From the Statens Serum Institut and the Danish Microbiological Departments, the numbers bacterial infections including PVL-producing S aureus bacteremias and RSV infection will be obtained.

Eligibility criteria: Inclusion Criteria:

* MIS-C according to criteria devised by the World Health Organization and Centers for Disease Control and Prevention (CDC)
* Invasive bacterial infections and viral infections secondary to SARS-CoV-2 or as consequence of SARS-CoV-2 lock down

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of MIS-C, invasive bacterial and viral infections
timeFrame: August to December 2021 (Delta); December 2021 to unknown (2022) (Omicron)
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Rigshospitalet
Study officials:
References:
citation: Nygaard U, Holm M, Hartling UB, Glenthoj J, Schmidt LS, Nordly SB, Matthesen AT, von Linstow ML, Espenhain L. Incidence and clinical phenotype of multisystem inflammatory syndrome in children after infection with the SARS-CoV-2 delta variant by vaccination status: a Danish nationwide prospective cohort study. Lancet Child Adolesc Health. 2022 Jul;6(7):459-465. doi: 10.1016/S2352-4642(22)00100-6. Epub 2022 May 6.