Seroprevalence and Immunoprotection Against COVID-19 in Parisian Children (AP-PEDCOVID)

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Other: no intervention. observational cohort study

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 Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Necker Hospital
    • Contact: SERMET Isabelle, Professor; Phone Number: 01 44 49 48 87; Email: isabelle.sermet@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All hospitalized children at Assistance Publique Hôpitaux de Paris

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serological test	Ab against SARS-CoV-2	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neutralizing Ab	activity of the antibodies against SARS-CoV2	48 weeks
Immuno phenotyping	Lymphocyte response phenotyping	48 weeks

Collaborators and Investigators

• Sponsor: Hôpital Necker-Enfants Malades

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 9, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (ACTUAL): July 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: HNeckerNM

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