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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04442087
Other study ID # APHP200627
Secondary ID 2020-A01480-39
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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