Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children

Study Overview
=================
Brief Summary
-----------------
This study is expected to provide, for the first time, data on Cov2-SARS circulation in asymptomatic children and children with moderate respiratory symptoms in order to construct the severity pyramid of this novel pathogen. This information will be essential in the coming weeks to understand the dynamics of the transmission of this pathogen at the population level and to highlight the relevance of public health interventions, particularly with regard to the systematic closure of schools and childcare facilities.

Detailed Description
-----------------
Cov2-SARS is an emerging respiratory virus of the coronavirus family responsible for a global epidemic since November 2019. As of March 10, 2020, it had caused more than 160,000 cases of corona virus disease (COVID-19), including more than 6,500 deaths worldwide. France is one of the main epidemic outbreaks with more than 5,000 confirmed cases and the number of diagnosed patients is increasing every day. The number of confirmed paediatric cases is relatively low, and the mortality rate in children is close to zero. This contrast suggests that children are more likely to present pauci-symptomatic or even asymptomatic forms of the disease, which are therefore undiagnosed in most cases. Given the rapid spread of this virus, and the fact that indigenous cases without an obvious chain of transmission now appear to be frequent in France, it is possible that the pauci-symptomatic or asymptomatic child may play a role in the transmission of the pathogen and the dynamics of the epidemic, as documented for other respiratory pathogens such as influenza. Based on this hypothesis, the closure of children's communities has been organized in France and other highly endemic countries.

Official Title
-----------------
Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care.

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Data collection and rhinopharyngeal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic children: Age between birth and 15 years Carrying out a visit within the framework defined by the learned societies and professional organisations representative of paediatrics in France, i.e. : The consultation of the first month and all consultations involving compulsory vaccinations (2, 4, 5, 11, 12, 16 months). Consultations for acute pathologies, infectious or not. Monitoring of chronic diseases that warrant clinical examination (the majority of which can be carried out by telemedicine) or in the case of acute exacerbation. In one of the participating outpatient centres During the study period With a clinical examination that does not reveal any progressive infectious pathology AND Pauci-symptomatic children Age between birth and 15 years, Consultant at one of the participating outpatient centres During the study period And presenting with a mild respiratory infection: Rhinopharyngitis, Acute otitis media, Angina, Bronchitis, etc. Acceptance to participate in the protocol by one of the holders of parental authority Affiliated to a social security Exclusion Criteria: Refusal to participate in the study

Ages Eligible for Study
-----------------
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Data collection and rhinopharyngeal swab<br>After information, the collection of consent will be carried out. A clinical information sheet will be completed by the investigator in order to collect socio-demographic data, history, clinical symptoms and signs, and complementary examinations performed. During the same consultation, a rhinopharyngeal swab will be taken for the detection of SARS -Cov2 and other respiratory pathogens by PCR. | Diagnostic Test: Data collection and rhinopharyngeal swab<br>* Testing for SARS -Cov2 and other respiratory pathogens by PCR via nasopharyngeal swabbing and IgM/IgG rapid serology<br>* Other names: IgM/IgG rapid 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 the Ile-de-France region during an epidemic period. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed Cov2-SARS cases by age | The proportion of confirmed Cov2-SARS cases in mildly-symptomatic and asymptomatic children in different age groups (defined as 6-23 months, 2-4 years, 5-9 years, 10-15 years). | 14 days | 
| Confirmed Cov2-SARS cases by symptoms | The proportion of confirmed Cov2-SARS cases based on the symptoms presented by the patients | 14 days | 
| Viral load | The viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) depending on the symptoms and the age of the patients | 14 days | 
| Other respiratory viruses | The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive | 14 days | 
| Sars-Cov2 IgM | Proportion of patients with Sars-Cov2 IgM + | 14 days | 
| Sars-Cov2 IgG | Proportion of patients with Sars-Cov2 IgG + | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sars-Cov2 rhino-pharyngeal carriage, primary care, children