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

NCT04416893 | Withdrawn

• 1 other identifier: COVILLE2
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cov2-SARS cases by age

  At inclusion

• Cov2-SARS cases by symptoms

  At inclusion

• Viral load

  At inclusion

• Presence of anti-SARS-CoV-2 antibodies (IgM and IgG) by the rapid serological test

  At inclusion

Study Arms (1)

Children under 15 years of age in a community

Children under 15 years of age in a community : kindergarten, school, college, holiday center, etc.

Diagnostic Test: RT-PCR SARS-Cov2; Diagnostic Test: Sars-Cov2 serology

Interventions

RT-PCR SARS-Cov2 DIAGNOSTIC_TEST

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

Children under 15 years of age in a community

Sars-Cov2 serology DIAGNOSTIC_TEST

A microsample of blood will be taken for serology

Children under 15 years of age in a community

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children under 15 years of age in a community (kindergarten, school, college, holiday centre, etc.).

You may qualify if:

• Birth to 15 years old
• taking over the community (kindergarten, school, college, holiday centre, etc.) for at least 1 week

You may not qualify if:

• refusal to participate

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Association Clinique Thérapeutique Infantile du val de Marne: collaborator
• Groupe de Pathologies Infectieuses Pédiatriques (GPIP): collaborator
• Francophone Pediatric Resuscitation and Emergency Group (GFRUP): collaborator

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: November 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share