Incidence of MIS-C and Other Complications Following SARS-CoV-2 Infection

NCT05186597 | Unknown

• 1 other identifier: H-20028631_MIS-C
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Incidence of MIS-C, invasive bacterial and viral infections

  August to December 2021 (Delta); December 2021 to unknown (2022) (Omicron)

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children and adolescents in the whole population of Denmark

You may qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Innovation Fund Denmark: collaborator
• Ministry of Education, Denmark: collaborator

Study Sites (1)

Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (2)

• Nygaard U, Hartling UB, Nielsen J, Vestergaard LS, Dungu KHS, Nielsen JSA, Sellmer A, Matthesen AT, Kristensen K, Holm M. Hospital admissions and need for mechanical ventilation in children with respiratory syncytial virus before and during the COVID-19 pandemic: a Danish nationwide cohort study. Lancet Child Adolesc Health. 2023 Mar;7(3):171-179. doi: 10.1016/S2352-4642(22)00371-6. Epub 2023 Jan 9.

  PMID: 36634692 DERIVED

• 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.

  PMID: 35526537 DERIVED

MeSH Terms

Conditions

COVID-19; pediatric multisystem inflammatory disease, COVID-19 related

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ulrikka Nygaard

CONTACT

40794656; Ulrikka@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: January 9, 2022
• First Posted: January 11, 2022
• Study Start: July 15, 2021
• Primary Completion: July 14, 2024
• Study Completion: December 31, 2024
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

DK (1)