NCT06255860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

February 7, 2024

Last Update Submit

November 19, 2024

Conditions

Sars-CoV-2 InfectionMIS-C

Outcome Measures

Primary Outcomes (3)

  • 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

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

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

    8 months

  • 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

Study Arms (2)

children with MIS-C

hospitalized children with MIS-C

SARS-CoV-2 infection

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

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children with SARS-CoV-2 and children with MIS-C between the 01 sep 2021 and 30 apr 2022 period

You may qualify if:

  • 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

You may not qualify if:

  • \- Refusal to participate by patient relative or legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACTIV

Créteil, 94000, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Corinne Levy, Physician

    Association Clinique Thérapeutique Infantile du val de Marne

    STUDY DIRECTOR

  • Naim Ouldali, Physician

    Hôpital Robert Debré AP-HP, Paris 19

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 13, 2024

Study Start

September 22, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)