Part 2 on the Study Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children (COVILLE2) (WHO)

COVID19 Clinical Trial

— COVILLE2  

Official 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04416893
• Other study ID #: COVILLE2
• Status: Withdrawn
• Start date: November 2020
• Est. completion date: April 2021

Study information

• Verified date: May 2021
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• COVID19

Intervention

Diagnostic Test:
• RT-PCR SARS-Cov2
nasopharyngeal swab will be taken for detection of SARS-CoV-2 by RT-PCR
• Sars-Cov2 serology
A microsample of blood will be taken for serology

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Association Clinique Thérapeutique Infantile du val de Marne, Francophone Pediatric Resuscitation and Emergency Group (GFRUP), GPIP

Outcome

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