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

Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care-Part 2 After the Lifting of the Lockdown

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID19
• Intervention / Treatment: Diagnostic test: RT-PCR SARS-Cov2; Diagnostic test: Sars-Cov2 serology

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children under 15 years of age in a community (kindergarten, school, college, holiday centre, etc.).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children under 15 years of age in a community; Children under 15 years of age in a community : kindergarten, school, college, holiday center, etc.	Diagnostic test: RT-PCR SARS-Cov2; nasopharyngeal swab will be taken for detection of SARS-CoV-2 by RT-PCR; Diagnostic test: Sars-Cov2 serology; A microsample of blood will be taken for serology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of asymptomatic children or children with mild respiratory symptoms	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	At inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: Association Clinique Thérapeutique Infantile du val de Marne; GPIP; Francophone Pediatric Resuscitation and Emergency Group (GFRUP)

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Children; RT-PCR SARS-CoV-2; Serology SARS-CoV-2
• Other Study ID Numbers: COVILLE2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No