FamilyPEDCOVID: Study of Seroprevalence of Anti-SARS-CoV2 Among Children of Hospital Workers in AP-HP

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT04442087

Collaborator

(none)

563

Enrollment

Location

10.3

Actual Duration (Months)

54.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV2	Biological: Serology SARS-CoV2 Behavioral: Data collection	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

563 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Seroprevalence of Anti-SARS-CoV2 Among Children According to Parents' SARS-CoV2 Serological Status. Study in a Hospital Population Assistance Publique-Hôpitaux Paris

Actual Study Start Date :

Jun 19, 2020

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

Apr 30, 2021

Outcome Measures

Primary Outcome Measures

Seroprevalence of antibodies anti- SARS Cov2 in blood sample of children of Hospital workers [at inclusion]
Percentage of children with seropositive in blood sample according to parents' SARS Cov2 serological status
Seroprevalence of antibodies anti- SARS Cov2 in saliva sample of children of Hospital workers [at inclusion]
Percentage of children with seropositive according in saliva sample to parents' SARS Cov2 serological status

Secondary Outcome Measures

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]
Number of Asymptomatic spouses of hospital workers with a positive serology [At inclusion]
Number of severely symptomatic spouses of hospital workers with a positive serology [At inclusion]
Comparison of Serological result obtained in blood and saliva samples [At inclusion]
Risk factors based on a questionnaire for children and adults [At inclusion]
the following factors will be of particular importance: characteristics and composition of the family home, barrier measures, medical history and comorbidities.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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:

Child (ren), spouse and any other member residing in the household of a professional of the Paris Center Hospitals meeting the inclusion criteria above.

Exclusion Criteria:

Refuse to participate in research

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre d'investigation clinique (CIC) Necker Cochin in Necker Children's Hospital	Paris		France	75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Study Director: Solen KERNEIS, MD, Assistance Publique - Hôpitaux de Paris
Study Director: Flore ROZENBERG, MD, PhD, Assistance Publique - Hôpitaux de Paris
Principal Investigator: Jean-Marc TRELUYER, MD, PhD, Assistance Publique - Hôpitaux de Paris