NCT04442087

Brief Summary

The purpose of this study is to define seroprevalence of anti-SARS-CoV2 among children of Hospital Workers in APHP, particularly exposed population, according to parents' SARS-CoV2 serological status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
563

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

June 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

June 8, 2020

Last Update Submit

November 17, 2025

Conditions

SARS-CoV2

Keywords

SARS-CoV2COVID-19SerologyHospital workersChildren

Outcome Measures

Primary Outcomes (2)

  • Seroprevalence of antibodies anti- SARS Cov2 in blood sample of children of Hospital workers

    Percentage of children with seropositive in blood sample according to parents' SARS Cov2 serological status

    at inclusion

  • Seroprevalence of antibodies anti- SARS Cov2 in saliva sample of children of Hospital workers

    Percentage of children with seropositive according in saliva sample to parents' SARS Cov2 serological status

    at inclusion

Secondary Outcomes (9)

  • Number of Asymptomatic Children with a positive seroloy

    At inclusion

  • Number of severely symptomatic Children with a positive serology

    At inclusion

  • Prevalence of different clinical symptoms in children with a positive serology

    At inclusion

  • Serological result of each member of the family

    At inclusion

  • Number of spouses of hospital workers with a positive serology

    At inclusion

  • +4 more secondary outcomes

Interventions

Serology SARS-CoV2BIOLOGICAL

Collect serum for Serology SARS-CoV2 at inclusion

Data collectionBEHAVIORAL

Collect clinical and demographic data, habitus, Lifestyle Counseling at inclusion

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hospital workers :
  • Individuals aged over 18, having a professional activity at the APHP (employees, interns, volunteers)
  • Affiliated to a social security regimen
  • Have at least one child under the age of 18 living in the same house.
  • have signed consent
  • Child (ren), spouse and other member (s) residing at household:

You may not qualify if:

  • Refuse to participate in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'investigation clinique (CIC) Necker Cochin in Necker Children's Hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Solen KERNEIS, MD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

  • Flore ROZENBERG, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

  • Jean-Marc TRELUYER, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 22, 2020

Study Start

June 19, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

November 20, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)