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OpenTrials
Completed

NCT Number: NCT06255860

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. proportion of MIS-C cases occurred after first SARS-CoV-2 infection

    Time frame: 8 months

    Assessment of risk of MIS-C after first SARS-CoV-2 infection

  2. proportion of MIS-C cases occurred after SARS-CoV-2 reinfection

    Time frame: 8 months

    Assessment of risk of MIS-C after SARS-CoV-2 reinfection

  3. Proportion of SARS-CoV-2 reinfection after first SARS-CoV-2 infection

    Time frame: 8 months

    Assessment of risk of SARS-CoV-2 reinfection after first SARS-CoV-2 infection

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Registry information

Official study title

SARS-COV-2 (virus Responsible of COVID-19) Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study

Acronym: REPI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.