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NCT06255860 Clinical Trial

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

Sars-CoV-2 Infection Clinical Trial

— REPI  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06255860
Other study ID # REPI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 22, 2023
Est. completion date April 1, 2024

Study information
Verified date January 2024
Source Association Clinique Thérapeutique Infantile du val de Marne
Contact Corinne Levy, physician
Phone 1 48 85 04 04
Email corinne.levy@activ-france.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 360
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France ACTIV Créteil

Sponsors (1)
Lead Sponsor Collaborator
Association Clinique Thérapeutique Infantile du val de Marne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary proportion of MIS-C cases occurred after first SARS-CoV-2 infection Assessment of risk of MIS-C after first SARS-CoV-2 infection 8 months
Primary proportion of MIS-C cases occurred after SARS-CoV-2 reinfection Assessment of risk of MIS-C after SARS-CoV-2 reinfection 8 months
Primary Proportion of SARS-CoV-2 reinfection after first SARS-CoV-2 infection Assessment of risk of SARS-CoV-2 reinfection after first SARS-CoV-2 infection 8 months
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