SARS-CoV2FamilyPEDCOVIDNCT04442087
Study of Seroprevalence of Anti-SARS-CoV2 Among Children of Hospital Workers in AP-HP
A study testing Serology SARS-CoV2 and Data collection in people with SARS-CoV2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2
- What is being tested?
- Serology SARS-CoV2 and Data collection
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 563 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Refuse to participate in research
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'investigation clinique (CIC) Necker Cochin in Necker Children's Hospital
Paris, 75015
About this study
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
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.
- Conditions
- SARS-CoV2
- Being tested
- Serology SARS-CoV2, Data collection
- Keywords
- SARS-CoV2, COVID-19, Serology, Hospital workers, Children
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serology SARS-CoV2Biological
Collect serum for Serology SARS-CoV2 at inclusion
Data collectionBehavioural
Collect clinical and demographic data, habitus, Lifestyle Counseling at inclusion
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: at inclusion
Secondary outcomes (9)
Number of Asymptomatic Children with a positive seroloy
Measured: At inclusion
Number of severely symptomatic Children with a positive serology
Measured: At inclusion
Prevalence of different clinical symptoms in children with a positive serology
Measured: At inclusion
Serological result of each member of the family
Measured: At inclusion
Number of spouses of hospital workers with a positive serology
Measured: At inclusion
Number of Asymptomatic spouses of hospital workers with a positive serology
Measured: At inclusion
Number of severely symptomatic spouses of hospital workers with a positive serology
Measured: At inclusion
Comparison of Serological result obtained in blood and saliva samples
Measured: At inclusion
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.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start19 Jun 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Solen KERNEIS, MD, Study director, Assistance Publique - Hôpitaux de ParisFlore ROZENBERG, MD, PhD, Study director, Assistance Publique - Hôpitaux de ParisJean-Marc TRELUYER, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442087
- Sponsor's protocol ID
- APHP200627
- Other IDs
- 2020-A01480-39
- Acronym
- FamilyPEDCOVID
- Status last verified
- Sep 2025
- First submitted
- 8 Jun 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04442087
- Acronym / sponsor ID
- FamilyPEDCOVID / APHP200627
- Conditions
- SARS-CoV2
- Keywords
- SARS-CoV2, COVID-19, Serology, Hospital workers, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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 any other member residing in the household of a professional of the Paris Center Hospitals meeting the inclusion criteria above.
Key exclusion criteria (1 listed)
- Refuse to participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serology SARS-CoV2Collect serum for Serology SARS-CoV2 at inclusion | Biological | – |
| Data collectionCollect clinical and demographic data, habitus, Lifestyle Counseling at inclusion | Behavioural | – |
Primary outcome
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
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
9 secondary outcomes
Number of Asymptomatic Children with a positive seroloy
Time frame: At inclusion
Number of severely symptomatic Children with a positive serology
Time frame: At inclusion
Prevalence of different clinical symptoms in children with a positive serology
Time frame: At inclusion
Serological result of each member of the family
Time frame: At inclusion
Number of spouses of hospital workers with a positive serology
Time frame: At inclusion
Number of Asymptomatic spouses of hospital workers with a positive serology
Time frame: At inclusion
Number of severely symptomatic spouses of hospital workers with a positive serology
Time frame: At inclusion
Comparison of Serological result obtained in blood and saliva samples
Time frame: At inclusion
Risk factors based on a questionnaire for children and adults
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Solen KERNEIS, MD study director
Assistance Publique - Hôpitaux de Paris
Flore ROZENBERG, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Jean-Marc TRELUYER, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serology SARS-CoV2 and Data collection in people with SARS-CoV2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprevalence of antibodies anti- SARS Cov2 in blood sample of children of Hospital workers (time frame: at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.