COVID19 Clinical Trial
— COVILLE2Official title:
Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care-Part 2 After the Lifting of the Lockdown
NCT number | NCT04416893 |
Other study ID # | COVILLE2 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | November 2020 |
Est. completion date | April 2021 |
Verified date | May 2021 |
Source | Centre Hospitalier Intercommunal Creteil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
France and in particular the paris area was one of the countries most affected by the pandemic Covid19. School closures and a generalized lockdown of the population were instituted in France from 17 March 2020 to 10 May 2020. Schools and nurseries have reopened partially since 11 May 2020. From 2 June, this reopening is more widespread. By combining the search for SARS-Cov2 viruses by PCR and micro-method serology we will be able to evaluate both the infection at a given time and also older contact with SARS-CoV2. The temporal knowledge of the prevalence of SARS-Cov2 carriage and the serological status (IgM and IgG) after return to the community are crucial information to evaluate the speed of spread of the virus in children. This is the objective of COVILLE2, phase 2 of the COVILLE study.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2021 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 15 Years |
Eligibility | Inclusion Criteria: - Birth to 15 years old - taking over the community (kindergarten, school, college, holiday centre, etc.) for at least 1 week Exclusion Criteria: - refusal to participate |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Intercommunal Creteil | Association Clinique Thérapeutique Infantile du val de Marne, Francophone Pediatric Resuscitation and Emergency Group (GFRUP), GPIP |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of asymptomatic children or children with mild respiratory symptoms | 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 Paris area | At inclusion | |
Secondary | Cov2-SARS cases by age | At inclusion | ||
Secondary | Cov2-SARS cases by symptoms | At inclusion | ||
Secondary | Viral load | The viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction depending on the symptoms and the age of the patients | At inclusion | |
Secondary | Presence of anti-SARS-CoV-2 antibodies (IgM and IgG) by the rapid serological test | At inclusion |
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