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

NCT ID: NCT06255860

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-22

Study Completion Date

2024-04-01

Brief Summary

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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

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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.

Conditions

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Sars-CoV-2 Infection MIS-C

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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children with MIS-C

hospitalized children with MIS-C

No interventions assigned to this group

SARS-CoV-2 infection

non hospitalized children infected with SARS-CoV-2 treated by outpatient care

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Association Clinique Thérapeutique Infantile du val de Marne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corinne Levy, Physician

Role: STUDY_DIRECTOR

Association Clinique Thérapeutique Infantile du val de Marne

Naim Ouldali, Physician

Role: PRINCIPAL_INVESTIGATOR

Hôpital Robert Debré AP-HP, Paris 19

Locations

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ACTIV

Créteil, , France

Site Status

Countries

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France

Other Identifiers

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REPI

Identifier Type: -

Identifier Source: org_study_id

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