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

NCT ID: NCT04318431

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 605 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-14
• Study Completion Date: 2020-06-01

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.

Conditions

Covid19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Data collection and rhinopharyngeal swab

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Data collection and rhinopharyngeal swab

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

IgM/IgG rapid serology

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

• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association Clinique Thérapeutique Infantile du val de Marne

OTHER

Sponsor Role: collaborator

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Cabinet du Dr D'acremont

Paris, , France

146 Avenue Ledru Rollin

Paris, , France

132 Boulevard du Montparnasse

Paris, , France

Cabinet du Dr Romain

Paris, , France

Cabinet du Dr Turberg-Romain

Paris, , France

15 Quai Louis Blériot

Paris, , France

Cabinet du Dr Michot

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, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33665371 (View on PubMed)

Other Identifiers

2020-A00724-35

Identifier Type: OTHER

Identifier Source: secondary_id

COVILLE

Identifier Type: -

Identifier Source: org_study_id