COVID-19AP-PEDCOVIDNCT04490811
Seroprevalence and Immunoprotection Against COVID-19 in Parisian Children
An observational study of COVID-19, run by Hôpital Necker-Enfants Malades at 1 site in France.
Trial summary
The paediatric population present mild or asymptomatic form of SARS-CoV-2 infection. This study asses the frequency of patients with SARS-CoV2 Antibodies (Ab) (seroprevalence) and the neutralizing typology of those Ab (immunoprotection) in children from 7 days to 18 years of age hospitalized for no more than 4 days… Read more about this study
- Who is it for?
- Ages 7 days to 18 years
- Conditions the study is for
- COVID-19
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2020to 31 Dec 2021
- Phase
- Observational
- 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 7 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All hospitalized children at Assistance Publique Hôpitaux de Paris
Who may be able to join
- any child over 7 days and under 18 years of age who has been hospitalized for no more than 4 days and who has a blood sample regardless of the symptoms;
Who cannot join
- Any child under 7 days
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Necker Hospital
Paris, 75014
SERMET Isabelle, Professor, 01 44 49 48 87, isabelle.sermet@aphp.fr
SERMET Isabelle, Professor, 01 44 49 48 87, isabelle.sermet@nck.aphp.fr
About this study
Official title: Seroprevalence and Immunoprotection Against SARS-CoV2 in Children Hospitalized in Paris
The paediatric population present mild or asymptomatic form of SARS-CoV-2 infection. This study asses the frequency of patients with SARS-CoV2 Antibodies (Ab) (seroprevalence) and the neutralizing typology of those Ab (immunoprotection) in children from 7 days to 18 years of age hospitalized for no more than 4 days and whose clinical status requires blood sample regardless of the symptoms Patients are included on a given day, after information, before blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to perform SARS-Cov2 serology.
Read the detailed description
Background of the study:
The fraction of undiagnosed cases is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV-2 emerging respiratory virus. These subjects most often present themselves in benign or totally asymptomatic form, although they are likely to spread the virus in the general population. The containment strategy was implemented in France to reverse the exponential epidemic growth of infection.
A crucial issue is the specific study of the paediatric population because the prevalence of symptomatic infections is low and children are mostly mild and under-diagnosed. Children could frequently be asymptomatic carriers and act as a real reservoir for the spread of the virus. In these "sub-symptomatic" carriers, the viral load may be low, and it is possible that PCR nasal tests may be defective. The serological study is therefore essential because it will inform us about the speed and effectiveness of seroconversion and therefore about the immunoprotection of this subpopulation.
The rationale for the study is that the proportion of children who have developed immunoprotection is decisive in defining measures to control the epidemic. It is essential to assess the prevalence and typology of antibody responses in this population and to follow kinetics over time.
The many emerging atypical forms and in particular the post-infectious kawasaki-like forms have a very particular immunopathological profile that provides information on the natural history of the disease.
Main objectives of the study to assess the prevalence of seroconversion (seroprevalence) in a pediatric population sample to study the immunopathological profile of clinical forms attributed to SARS-CoV-2 infection
Design of the study Patients are included on a given day, after information, before blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to perform SARS-Cov2 serology. According to data currently collected in France, 5% of children taken from symptoms are infected. Given that nasopharyngeal testing is lacking in this pediatric population, we anticipate an increase in the number of subjects who have been infected or have an ongoing infection at least 10%. A sample of 800 subjects will therefore include at least 80 children with infection.
A questionnaire will extract relevant variables to this project:
- Any symptoms of the index case or his family since December 2019 consistent with COVID-19
- Comorbidities and treatment
- Reason for hospitalization
- History of contact case
- Clinical signs on the day of collection
- Result of RT-PCT SARS-CoV2 nasopharyngeal if made in the index case
- Conditions
- COVID-19
- Being tested
- no intervention. observational cohort study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention. observational cohort studyOther
Also called no intervention
blood sampling is part of care
What is being measured
The primary outcome is the main question the study is designed to answer.
serological test
Ab against SARS-CoV-2
Measured: 48 weeks
Secondary outcomes (2)
neutralizing Ab
activity of the antibodies against SARS-CoV2
Measured: 48 weeks
Immuno phenotyping
Lymphocyte response phenotyping
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start9 Apr 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Necker-Enfants Malades
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Sermet-Gaudelus, Hôpital Necker-Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490811
- Sponsor's protocol ID
- HNeckerNM
- Acronym
- AP-PEDCOVID
- Status last verified
- Jul 2020
- First submitted
- 20 Jun 2020
- Last updated
- 29 Jul 2020
- 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 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence and Immunoprotection Against SARS-CoV2 in Children Hospitalized in Paris
- ClinicalTrials.gov ID
- NCT04490811
- Acronym / sponsor ID
- AP-PEDCOVID / HNeckerNM
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Hôpital Necker-Enfants MaladesUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Jul 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 paediatric population present mild or asymptomatic form of SARS-CoV-2 infection. This study asses the frequency of patients with SARS-CoV2 Antibodies (Ab) (seroprevalence) and the neutralizing typology of those Ab (immunoprotection) in children from 7 days to 18 years of age hospitalized for no more than 4 days and whose clinical status requires blood sample regardless of the symptoms Patients are included on a given day, after information, before blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to perform SARS-Cov2 serology.
Detailed description
Background of the study:
The fraction of undiagnosed cases is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV-2 emerging respiratory virus. These subjects most often present themselves in benign or totally asymptomatic form, although they are likely to spread the virus in the general population. The containment strategy was implemented in France to reverse the exponential epidemic growth of infection.
A crucial issue is the specific study of the paediatric population because the prevalence of symptomatic infections is low and children are mostly mild and under-diagnosed. Children could frequently be asymptomatic carriers and act as a real reservoir for the spread of the virus. In these "sub-symptomatic" carriers, the viral load may be low, and it is possible that PCR nasal tests may be defective. The serological study is therefore essential because it will inform us about the speed and effectiveness of seroconversion and therefore about the immunoprotection of this subpopulation.
The rationale for the study is that the proportion of children who have developed immunoprotection is decisive in defining measures to control the epidemic. It is essential to assess the prevalence and typology of antibody responses in this population and to follow kinetics over time.
The many emerging atypical forms and in particular the post-infectious kawasaki-like forms have a very particular immunopathological profile that provides information on the natural history of the disease.
Main objectives of the study to assess the prevalence of seroconversion (seroprevalence) in a pediatric population sample to study the immunopathological profile of clinical forms attributed to SARS-CoV-2 infection
Design of the study Patients are included on a given day, after information, before blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to perform SARS-Cov2 serology. According to data currently collected in France, 5% of children taken from symptoms are infected. Given that nasopharyngeal testing is lacking in this pediatric population, we anticipate an increase in the number of subjects who have been infected or have an ongoing infection at least 10%. A sample of 800 subjects will therefore include at least 80 children with infection.
A questionnaire will extract relevant variables to this project:
- Any symptoms of the index case or his family since December 2019 consistent with COVID-19
- Comorbidities and treatment
- Reason for hospitalization
- History of contact case
- Clinical signs on the day of collection
- Result of RT-PCT SARS-CoV2 nasopharyngeal if made in the index case
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 7 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All hospitalized children at Assistance Publique Hôpitaux de Paris
Key inclusion criteria (1 listed)
- any child over 7 days and under 18 years of age who has been hospitalized for no more than 4 days and who has a blood sample regardless of the symptoms;
Key exclusion criteria (1 listed)
- Any child under 7 days
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 |
|---|---|---|
| no intervention. observational cohort studyAlso: no interventionblood sampling is part of care | Other | – |
Primary outcome
serological test
Time frame: 48 weeks
Ab against SARS-CoV-2
2 secondary outcomes
neutralizing Ab
Time frame: 48 weeks
Immuno phenotyping
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Hôpital Necker-Enfants Malades 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 1 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Tourenne (1 58 41 12 87 ext. +33, philippe.tourenne@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serological test (time frame: 48 weeks). 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 29 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.