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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318431
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
ACTIV
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Covid19 Diagnostic Test: Data collection and rhinopharyngeal swab Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care.
Actual Study Start Date : April 14, 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
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 Name: IgM/IgG rapid serology




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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

  4. Other respiratory viruses [ Time Frame: 14 days ]
    The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive

  5. Sars-Cov2 IgM [ Time Frame: 14 days ]
    Proportion of patients with Sars-Cov2 IgM +

  6. Sars-Cov2 IgG [ Time Frame: 14 days ]
    Proportion of patients with Sars-Cov2 IgG +



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asymptomatic children:
  • Age between 6 months 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
  • Pauci-symptomatic children
  • Age between 6 months 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318431


Contacts
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Contact: Camille JUNG, MD 01 45 17 50 00 camille.jung@chicreteil.fr

Locations
Show Show 22 study locations
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
ACTIV
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT04318431    
Other Study ID Numbers: COVILLE
2020-A00724-35 ( Other Identifier: ID-RCB )
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Intercommunal Creteil:
Sars-Cov2 rhino-pharyngeal carriage
primary care
children