Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children
- Conditions
- Covid19
- Interventions
- Diagnostic Test: Data collection and rhinopharyngeal swab
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 605
- 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
- Refusal to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Data collection and rhinopharyngeal swab Data collection and rhinopharyngeal swab 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.
- 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)
14 Av rené Samuel
🇫🇷Clamart, France
Cabinet du Dr Belaroussi
🇫🇷Boulogne, France
Cabinet du Dr Michot
🇫🇷Paris, France
Cabinet du Dr Cohen
🇫🇷Saint-Maur-des-Fossés, France
Cabinet du Dr Derkx
🇫🇷Champigny-sur-Marne, France
Cabinet du Dr Coicadan
🇫🇷Chennevières-sur-Marne, France
157 Avenue du Général Leclerc
🇫🇷Maisons-Alfort, France
21 Grande Rue Charles de Gaulle
🇫🇷Nogent-sur-Marne, France
Cabinet du Dr Wollner
🇫🇷Nogent-sur-Marne, France
4 allée des Norottes
🇫🇷Noisy-le-Grand, France
Cabinet du Dr D'acremont
🇫🇷Paris, France
24 rue Volta
🇫🇷Puteaux, France
Cabinet du Dr Turberg-Romain
🇫🇷Paris, France
146 Avenue Ledru Rollin
🇫🇷Paris, France
132 Boulevard du Montparnasse
🇫🇷Paris, France
Cabinet du Dr Romain
🇫🇷Paris, France
Cabinet de Pédiatrie des Docteurs Ravilly et Bessa
🇫🇷Villejuif, France
13 Villa Beauséjour
🇫🇷Vincennes, France
15 Quai Louis Blériot
🇫🇷Paris, France
Cabinet du Dr Corrard
🇫🇷Combs-la-Ville, France
10 rue Delambre
🇫🇷Lagny-sur-Marne, France
Cabinet du Dr Deberdt
🇫🇷Nogent-sur-Marne, France