Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children (COVILLE)
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|ClinicalTrials.gov Identifier: NCT04318431|
Recruitment Status : Completed
First Posted : March 24, 2020
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Diagnostic Test: Data collection and rhinopharyngeal swab||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||605 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||May 12, 2020|
|Actual Study Completion Date :||June 1, 2020|
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
- 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.
- 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 +
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