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

SARS-CoV2 Clinical Trial

— FamilyPEDCOVID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04442087
• Other study ID #: APHP200627
• Secondary ID: 2020-A01480-39
• Status: Completed
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Hospital workers :

1. Individuals aged over 18, having a professional activity at the APHP (employees, interns, volunteers)

2. Affiliated to a social security regimen

3. Have at least one child under the age of 18 living in the same house.

4. 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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2

Intervention

Biological:
• Serology SARS-CoV2
Collect serum for Serology SARS-CoV2 at inclusion

Behavioral:
• Data collection
Collect clinical and demographic data, habitus, Lifestyle Counseling at inclusion

Locations

Country	Name	City	State
France	Centre d'investigation clinique (CIC) Necker Cochin in Necker Children's Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Asymptomatic Children with a positive seroloy		At inclusion
Secondary	Number of severely symptomatic Children with a positive serology		At inclusion
Secondary	Prevalence of different clinical symptoms in children with a positive serology		At inclusion
Secondary	Serological result of each member of the family		At inclusion
Secondary	Number of spouses of hospital workers with a positive serology		At inclusion
Secondary	Number of Asymptomatic spouses of hospital workers with a positive serology		At inclusion
Secondary	Number of severely symptomatic spouses of hospital workers with a positive serology		At inclusion
Secondary	Comparison of Serological result obtained in blood and saliva samples		At inclusion
Secondary	Risk factors based on a questionnaire for children and adults	the following factors will be of particular importance: characteristics and composition of the family home, barrier measures, medical history and comorbidities.	At inclusion