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

Not Applicable

Completed

• Conditions: Covid19

• Registration Number: NCT04318431
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Study Start: 2020-04-14
• Primary Completion: 2020-05-12
• Study Completion: 2020-06-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 605

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of asymptomatic children or children with mild respiratory symptoms	14 days	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.

Secondary Outcome Measures

Name	Time	Method
Confirmed Cov2-SARS cases by symptoms	14 days	The proportion of confirmed Cov2-SARS cases based on the symptoms presented by the patients
Viral load	14 days	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
Other respiratory viruses	14 days	The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive
Sars-Cov2 IgM	14 days	Proportion of patients with Sars-Cov2 IgM +
Confirmed Cov2-SARS cases by age	14 days	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).
Sars-Cov2 IgG	14 days	Proportion of patients with Sars-Cov2 IgG +

Trial Locations

Locations (22)

Cabinet du Dr Belaroussi; 🇫🇷 Boulogne, France

Cabinet du Dr Derkx; 🇫🇷 Champigny-sur-Marne, France

Cabinet du Dr Coicadan; 🇫🇷 Chennevières-sur-Marne, France

14 Av rené Samuel; 🇫🇷 Clamart, France

Cabinet du Dr Corrard; 🇫🇷 Combs-la-Ville, France

10 rue Delambre; 🇫🇷 Lagny-sur-Marne, France

157 Avenue du Général Leclerc; 🇫🇷 Maisons-Alfort, France

21 Grande Rue Charles de Gaulle; 🇫🇷 Nogent-sur-Marne, France

Cabinet du Dr Deberdt; 🇫🇷 Nogent-sur-Marne, France

Cabinet du Dr Wollner; 🇫🇷 Nogent-sur-Marne, France

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