Clinical trial NCT04318431: Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children
Official title: Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Sars-Cov2 rhino-pharyngeal carriage
primary care
children
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Association Clinique Thérapeutique Infantile du val de Marne
First posted: 2020-03-24
Enrollment: 605
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Proportion of asymptomatic children or children with mild respiratory symptoms
timeFrame: 14 days
Secondary outcomes:
measure: Confirmed Cov2-SARS cases by age
timeFrame: 14 days
measure: Confirmed Cov2-SARS cases by symptoms
timeFrame: 14 days
measure: Viral load
timeFrame: 14 days
measure: Other respiratory viruses
timeFrame: 14 days
measure: Sars-Cov2 IgM
timeFrame: 14 days
measure: Sars-Cov2 IgG
timeFrame: 14 days
Other outcomes:
Locations:
city: Boulogne
country: France
facility: Cabinet du Dr Belaroussi
city: Champigny-sur-Marne
country: France
facility: Cabinet du Dr Derkx
city: Chennevières-sur-Marne
country: France
facility: Cabinet du Dr Coicadan
city: Clamart
country: France
facility: 14 Av rené Samuel
city: Combs-la-Ville
country: France
facility: Cabinet du Dr Corrard
city: Lagny-sur-Marne
country: France
facility: 10 rue Delambre
city: Maisons-Alfort
country: France
facility: 157 Avenue du Général Leclerc
city: Nogent-sur-Marne
country: France
facility: 21 Grande Rue Charles de Gaulle
city: Nogent-sur-Marne
country: France
facility: Cabinet du Dr Deberdt
city: Nogent-sur-Marne
country: France
facility: Cabinet du Dr Wollner
city: Noisy-le-Grand
country: France
facility: 4 allée des Norottes
city: Paris
country: France
facility: Cabinet du Dr D'acremont
city: Paris
country: France
facility: 146 Avenue Ledru Rollin
city: Paris
country: France
facility: 132 Boulevard du Montparnasse
city: Paris
country: France
facility: Cabinet du Dr Romain
city: Paris
country: France
facility: Cabinet du Dr Turberg-Romain
city: Paris
country: France
facility: 15 Quai Louis Blériot
city: Paris
country: France
facility: Cabinet du Dr Michot
city: Puteaux
country: France
facility: 24 rue Volta
city: Saint-Maur-des-Fossés
country: France
facility: Cabinet du Dr Cohen
city: Villejuif
country: France
facility: Cabinet de Pédiatrie des Docteurs Ravilly et Bessa
city: Vincennes
country: France
facility: 13 Villa Beauséjour
Study officials:
References:
citation: Cohen R, Jung C, Ouldali N, Sellam A, Batard C, Cahn-Sellem F, Elbez A, Wollner A, Romain O, Corrard F, Aberrane S, Soismier N, Creidy R, Smati-Lafarge M, Launay O, Bechet S, Varon E, Levy C. Assessment of SARS-CoV-2 infection by Reverse transcription-PCR and serology in the Paris area: a cross-sectional study. BMJ Paediatr Open. 2020 Dec 29;4(1):e000887. doi: 10.1136/bmjpo-2020-000887. eCollection 2020.