Part 2 on the Study Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children (COVILLE2) (WHO)

Withdrawn

• Conditions: COVID19
• Interventions: Diagnostic Test: RT-PCR SARS-Cov2; Diagnostic Test: Sars-Cov2 serology

• Registration Number: NCT04416893
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

France and in particular the paris area was one of the countries most affected by the pandemic Covid19.

School closures and a generalized lockdown of the population were instituted in France from 17 March 2020 to 10 May 2020. Schools and nurseries have reopened partially since 11 May 2020. From 2 June, this reopening is more widespread. By combining the search for SARS-Cov2 viruses by PCR and micro-method serology we will be able to evaluate both the infection at a given time and also older contact with SARS-CoV2.

The temporal knowledge of the prevalence of SARS-Cov2 carriage and the serological status (IgM and IgG) after return to the community are crucial information to evaluate the speed of spread of the virus in children. This is the objective of COVILLE2, phase 2 of the COVILLE study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Study Start: 2020-11
• Primary Completion: 2021-01
• Study Completion: 2021-04
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Birth to 15 years old
• taking over the community (kindergarten, school, college, holiday centre, etc.) for at least 1 week

Exclusion Criteria

• refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children under 15 years of age in a community	Sars-Cov2 serology	Children under 15 years of age in a community : kindergarten, school, college, holiday center, etc.
Children under 15 years of age in a community	RT-PCR SARS-Cov2	Children under 15 years of age in a community : kindergarten, school, college, holiday center, etc.

Primary Outcome Measures

Name	Time	Method
Proportion of asymptomatic children or children with mild respiratory symptoms	At inclusion	Proportion of asymptomatic children or children with mild respiratory symptoms (mildly-symptomatic children) with a positive SARS-Cov2 Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on rhino pharyngeal swab or/and IgM/IgG positive serology in Paris area

Secondary Outcome Measures

Name	Time	Method
Cov2-SARS cases by age	At inclusion
Viral load	At inclusion	The viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction depending on the symptoms and the age of the patients
Cov2-SARS cases by symptoms	At inclusion
Presence of anti-SARS-CoV-2 antibodies (IgM and IgG) by the rapid serological test	At inclusion