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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04416893
Acronym
COVILLE2
Enrollment
0
Registered
2020-06-04
Start date
2020-11-30
Completion date
2021-04-30
Last updated
2021-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID19

Keywords

RT-PCR SARS-CoV-2, Serology SARS-CoV-2, Children

Brief 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.

Interventions

DIAGNOSTIC_TESTRT-PCR SARS-Cov2

nasopharyngeal swab will be taken for detection of SARS-CoV-2 by RT-PCR

DIAGNOSTIC_TESTSars-Cov2 serology

A microsample of blood will be taken for serology

Sponsors

Association Clinique Thérapeutique Infantile du val de Marne
CollaboratorOTHER
Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
CollaboratorOTHER
Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
CollaboratorOTHER
Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of asymptomatic children or children with mild respiratory symptomsAt inclusionProportion 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

Secondary

MeasureTime frameDescription
Cov2-SARS cases by ageAt inclusion
Cov2-SARS cases by symptomsAt inclusion
Viral loadAt inclusionThe viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction depending on the symptoms and the age of the patients
Presence of anti-SARS-CoV-2 antibodies (IgM and IgG) by the rapid serological testAt inclusion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026