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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04318431
Acronym
COVILLE
Enrollment
605
Registered
2020-03-24
Start date
2020-04-14
Completion date
2020-06-01
Last updated
2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Sars-Cov2 rhino-pharyngeal carriage, primary care, children

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.

Interventions

DIAGNOSTIC_TESTData collection and rhinopharyngeal swab

Testing for SARS -Cov2 and other respiratory pathogens by PCR via nasopharyngeal swabbing and IgM/IgG rapid serology

Sponsors

Association Clinique Thérapeutique Infantile du val de Marne
CollaboratorOTHER
Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of asymptomatic children or children with mild respiratory symptoms14 daysProportion 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.

Secondary

MeasureTime frameDescription
Confirmed Cov2-SARS cases by symptoms14 daysThe proportion of confirmed Cov2-SARS cases based on the symptoms presented by the patients
Viral load14 daysThe 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
Confirmed Cov2-SARS cases by age14 daysThe 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).
Sars-Cov2 IgM14 daysProportion of patients with Sars-Cov2 IgM +
Sars-Cov2 IgG14 daysProportion of patients with Sars-Cov2 IgG +
Other respiratory viruses14 daysThe proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026