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

July 8, 2020 updated by: Centre Hospitalier Intercommunal Creteil

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

605

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne, France, 92100
        • Cabinet du Dr Belaroussi
      • Champigny-sur-Marne, France, 94500
        • Cabinet du Dr Derkx
      • Chennevières-sur-Marne, France, 94430
        • Cabinet du Dr Coicadan
      • Clamart, France, 92140
        • 14 Av rené Samuel
      • Combs-la-Ville, France, 77380
        • Cabinet du Dr Corrard
      • Lagny-sur-Marne, France, 77400
        • 10 rue Delambre
      • Maisons-Alfort, France, 94700
        • 157 Avenue du Général Leclerc
      • Nogent-sur-Marne, France, 94130
        • 21 Grande Rue Charles de Gaulle
      • Nogent-sur-Marne, France, 94130
        • Cabinet du Dr Deberdt
      • Nogent-sur-Marne, France, 94130
        • Cabinet du Dr Wollner
      • Noisy-le-Grand, France, 93160
        • 4 allée des Norottes
      • Paris, France, 75009
        • Cabinet du Dr D'acremont
      • Paris, France, 75011
        • 146 Avenue Ledru Rollin
      • Paris, France, 75014
        • 132 Boulevard du Montparnasse
      • Paris, France, 75015
        • Cabinet du Dr Romain
      • Paris, France, 75015
        • Cabinet du Dr Turberg-Romain
      • Paris, France, 75016
        • 15 Quai Louis Blériot
      • Paris, France, 75016
        • Cabinet du Dr Michot
      • Puteaux, France, 92800
        • 24 rue Volta
      • Saint-Maur-des-Fossés, France, 94100
        • Cabinet du Dr Cohen
      • Villejuif, France, 94800
        • Cabinet de Pédiatrie des Docteurs Ravilly et Bessa
      • Vincennes, France, 94300
        • 13 Villa Beauséjour

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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
Other Names:
  • IgM/IgG rapid serology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of asymptomatic children or children with mild respiratory symptoms
Time Frame: 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.
14 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Collaborators

Association Clinique Thérapeutique Infantile du val de Marne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2020

Primary Completion (Actual)

May 12, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COVILLE
  • 2020-A00724-35 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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