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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COVID19

Intervention / Treatment
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* Diagnostic Test: RT-PCR SARS-Cov2
* Diagnostic Test: Sars-Cov2 serology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children under 15 years of age in a community<br>Children under 15 years of age in a community : kindergarten, school, college, holiday center, etc. | Diagnostic Test: RT-PCR SARS-Cov2<br>* nasopharyngeal swab will be taken for detection of SARS-CoV-2 by RT-PCR<br>Diagnostic Test: Sars-Cov2 serology<br>* A microsample of blood will be taken for serology<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RT-PCR SARS-CoV-2, Serology SARS-CoV-2, Children