COVID-19 and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk / World Health Organization (WHO)

Completed

• Conditions: MIS-C; Sars-CoV-2 Infection

• Registration Number: NCT06255860
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

Brief Summary

This study is a multicenter, international, non interventional, retrospective study about SARS-CoV-2 and Multisystem Inflammatory Syndrome (MIS-C) reinfection risk in children.

Detailed Description

This study is based to data collection of cases (patients with MIS-C) compare to controls (patients with SARS-CoV-2 infection) occurring between 01 sep 2021 and 30 apr 2022. For this study cases and controls group will be matched for analyses.

The main of this study is to evaluate the difference of risk of occurrence of MIS-C between a first SARS-CoV-2 infection and a reinfection with SARS-CoV-2.

Study Timeline

• Study Start: 2023-09-22
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-13
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

group 1: cases

• Patients with MIS-C (following SARS CoV-2 infection)
• Hospitalised between the 01 sep 2021 and 30 apr 2022
• Under 18 years of age
• Not vaccinated for SARS-CoV-2

group 2: controls

• Patients not hospitalised, treated by outpatient care
• With documented SARS-CoV-2 infection between the 01 sep 2021 and 30 apr 2022
• Matched with a case on age (+/- 6 months), gender and country
• Not vaccinated for SARS-CoV-2

Exclusion Criteria

• Refusal to participate by patient relative or legal representative

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of MIS-C cases occurred after first SARS-CoV-2 infection	8 months	Assessment of risk of MIS-C after first SARS-CoV-2 infection
proportion of MIS-C cases occurred after SARS-CoV-2 reinfection	8 months	Assessment of risk of MIS-C after SARS-CoV-2 reinfection
Proportion of SARS-CoV-2 reinfection after first SARS-CoV-2 infection	8 months	Assessment of risk of SARS-CoV-2 reinfection after first SARS-CoV-2 infection

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Créteil, France