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

Covid19 Clinical Trial

— COVILLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318431
• Other study ID #: COVILLE
• Secondary ID: 2020-A00724-35
• Status: Completed
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: June 1, 2020
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Diagnostic Test:
• Data collection and rhinopharyngeal swab
Testing for SARS -Cov2 and other respiratory pathogens by PCR via nasopharyngeal swabbing and IgM/IgG rapid serology

Locations

Country	Name	City	State
France	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	4 allée des Norottes	Noisy-le-Grand
France	132 Boulevard du Montparnasse	Paris
France	146 Avenue Ledru Rollin	Paris
France	15 Quai Louis Blériot	Paris
France	Cabinet du Dr D'acremont	Paris
France	Cabinet du Dr Michot	Paris
France	Cabinet du Dr Romain	Paris
France	Cabinet du Dr Turberg-Romain	Paris
France	24 rue Volta	Puteaux
France	Cabinet du Dr Cohen	Saint-Maur-des-Fossés
France	Cabinet de Pédiatrie des Docteurs Ravilly et Bessa	Villejuif
France	13 Villa Beauséjour	Vincennes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Association Clinique Thérapeutique Infantile du val de Marne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Confirmed Cov2-SARS cases by symptoms	The proportion of confirmed Cov2-SARS cases based on the symptoms presented by the patients	14 days
Secondary	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
Secondary	Other respiratory viruses	The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive	14 days
Secondary	Sars-Cov2 IgM	Proportion of patients with Sars-Cov2 IgM +	14 days
Secondary	Sars-Cov2 IgG	Proportion of patients with Sars-Cov2 IgG +	14 days