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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318431
Recruitment Status : Completed
First Posted : March 24, 2020
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
Association Clinique Thérapeutique Infantile du val de Marne
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Tracking Information
First Submitted Date  ICMJE March 20, 2020
First Posted Date  ICMJE March 24, 2020
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE April 14, 2020
Actual Primary Completion Date May 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
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 in the Ile-de-France region during an epidemic period.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • 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).
  • 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
  • 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
  • Other respiratory viruses [ Time Frame: 14 days ]
    The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive
  • Sars-Cov2 IgM [ Time Frame: 14 days ]
    Proportion of patients with Sars-Cov2 IgM +
  • Sars-Cov2 IgG [ Time Frame: 14 days ]
    Proportion of patients with Sars-Cov2 IgG +
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • 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).
  • 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
  • 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
  • Other respiratory viruses [ Time Frame: 14 days ]
    The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children
Official Title  ICMJE Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Covid19
Intervention  ICMJE 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 Name: IgM/IgG rapid serology
Study Arms  ICMJE 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.

Intervention: Diagnostic Test: Data collection and rhinopharyngeal swab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2020)
605
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2020)
600
Actual Study Completion Date  ICMJE June 1, 2020
Actual Primary Completion Date May 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04318431
Other Study ID Numbers  ICMJE COVILLE
2020-A00724-35 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Intercommunal Creteil
Study Sponsor  ICMJE Centre Hospitalier Intercommunal Creteil
Collaborators  ICMJE Association Clinique Thérapeutique Infantile du val de Marne
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Intercommunal Creteil
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP