- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04442087
Study of Seroprevalence of Anti-SARS-CoV2 Among Children of Hospital Workers in AP-HP (FamilyPEDCOVID)
November 19, 2021 updated by: Assistance Publique - Hôpitaux de Paris
Seroprevalence of Anti-SARS-CoV2 Among Children According to Parents' SARS-CoV2 Serological Status. Study in a Hospital Population Assistance Publique-Hôpitaux Paris
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
563
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75015
- Centre d'investigation clinique (CIC) Necker Cochin in Necker Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroprevalence of antibodies anti- SARS Cov2 in blood sample of children of Hospital workers
Time Frame: at inclusion
|
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
Time Frame: at inclusion
|
Percentage of children with seropositive according in saliva sample to parents' SARS Cov2 serological status
|
at inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Asymptomatic Children with a positive seroloy
Time Frame: At inclusion
|
At inclusion
|
|
Number of severely symptomatic Children with a positive serology
Time Frame: At inclusion
|
At inclusion
|
|
Prevalence of different clinical symptoms in children with a positive serology
Time Frame: At inclusion
|
At inclusion
|
|
Serological result of each member of the family
Time Frame: At inclusion
|
At inclusion
|
|
Number of spouses of hospital workers with a positive serology
Time Frame: At inclusion
|
At inclusion
|
|
Number of Asymptomatic spouses of hospital workers with a positive serology
Time Frame: At inclusion
|
At inclusion
|
|
Number of severely symptomatic spouses of hospital workers with a positive serology
Time Frame: At inclusion
|
At inclusion
|
|
Comparison of Serological result obtained in blood and saliva samples
Time Frame: At inclusion
|
At inclusion
|
|
Risk factors based on a questionnaire for children and adults
Time Frame: At inclusion
|
the following factors will be of particular importance: characteristics and composition of the family home, barrier measures, medical history and comorbidities.
|
At inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Solen KERNEIS, MD, Assistance Publique - Hôpitaux de Paris
- Study Director: Flore ROZENBERG, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 19, 2020
Primary Completion (ACTUAL)
April 30, 2021
Study Completion (ACTUAL)
April 30, 2021
Study Registration Dates
First Submitted
June 8, 2020
First Submitted That Met QC Criteria
June 19, 2020
First Posted (ACTUAL)
June 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 22, 2021
Last Update Submitted That Met QC Criteria
November 19, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- APHP200627
- 2020-A01480-39 (REGISTRY: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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