Official Title
Seroprevalence and Immunoprotection Against SARS-CoV2 in Children Hospitalized in Paris
Brief 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 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

Unknown status
COVID-19

Other: no intervention. observational cohort study

blood sampling is part of care
Other Name: no intervention

Eligibility Criteria

Inclusion Criteria:

- 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;

Exclusion Criteria:

- Any child under 7 days

Eligibility Gender
All
Eligibility Age
Minimum: 7 Days ~ Maximum: 18 Years
Countries
France
Locations

Necker Hospital
Paris, France

Investigator: SERMET Isabelle, Professor
Contact: 01 44 49 48 87
isabelle.sermet@aphp.fr

Investigator: SERMET Isabelle, Professor

Contacts

Philippe Tourenne
1 58 41 12 87 - +33
philippe.tourenne@aphp.fr

Hôpital Necker-Enfants Malades
NCT Number
MeSH Terms
COVID-19