Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19 (PED-COVID)

Seroprevalence and Antibody Profiling Against SARS-CoV2 in Children and Their Parents

The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.

Study Overview

• Status: Completed
• Conditions: COVID-19 Infection
• Intervention / Treatment: Biological: serology test; Biological: nasopharyngeal swab; Biological: rectal swab; Biological: saliva sample

Detailed Description

The fraction of undiagnosed but likely to transmit the virus is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV2. To adapt the epidemy control, it is essential to study the immunoprotection of the general population. A crucial question is the study of pauci or asymptomatic subjects, and in particular children who make mild forms, because they could act as a real reservoir for the spread of the virus. The serological study is essential in this context.

The serologic test Abbott will be used to study immunoprevalence. Institut Pasteur has validated test using neutralizing Ab. CEA will used a antibodies and antigen test.

• Study Type: Interventional
• Enrollment (Actual): 1056
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • ¨Paris, France, 75015
    • Hôpital Necker Enfants-Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

For hospitalized children or consulting at hospital

• any child over 7 days old and under 17 years old in consultation or hospitalized for at most 4 days at AP-HP or CH Cayenne; Or any child over 7 days old and under 17 years old with a positive PCR at home, with an attending physician in a participating centre
• Parent's agreement for blood, saliva and stool samples
• Optional parent's agreement for nasopharynx swab
• Optional parent's agreement for follow-up if PCR+
• With an Health insurance

For children with potential COVID disease during the first wave

• Any child over 7 days old and under 17 years, seropositive during the first wave
• Or any child over 7 days old and under 17 years, with a previous inflammatory clinical disease potentially linked to SARS-cov2
• With an Health insurance

Parent of the enrolled child

• One parent of the enrolled child on ped-covid
• Agreement for blood and saliva samples
• Optional agreement for nasopharynx swab
• Optional parent's agreement for follow-up if PCR+
• With an Health insurance

For children SARS-coV2 positive

• any child less then 18 years old
• infected by SARS-coV2
• Parent's agreement for blood, saliva samples
• Optional parent's agreement for nasopharynx swab
• With health insurance

For people living under the same roof of a child included in the study

• any child or adult living under the same roof of a child SARS-coV2 positive and included in the study
• With health insurance

Exclusion Criteria:

For hospitalized children or consulting at hospital

• child younger than 7 days
• Refusal of parent
• Refusal of child
• No health insurance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hospitalized children or consulting at hospital	Biological: serology test; volume according to child weight; Biological: nasopharyngeal swab; nasopharyngeal swab for PCR; Biological: rectal swab; rectal swab for PCR; Biological: saliva sample; for biocollection
Experimental: Parents of one included child	Biological: serology test; volume according to child weight; Biological: nasopharyngeal swab; nasopharyngeal swab for PCR; Biological: saliva sample; for biocollection
Experimental: Children with potential COVID disease during the first wave	Biological: serology test; volume according to child weight; Biological: nasopharyngeal swab; nasopharyngeal swab for PCR; Biological: rectal swab; rectal swab for PCR; Biological: saliva sample; for biocollection
Experimental: Children SARS-coV2 positive	Biological: serology test; volume according to child weight; Biological: nasopharyngeal swab; nasopharyngeal swab for PCR; Biological: rectal swab; rectal swab for PCR; Biological: saliva sample; for biocollection
Experimental: Person living under the same roof as children included in the study	Biological: serology test; volume according to child weight; Biological: nasopharyngeal swab; nasopharyngeal swab for PCR; Biological: rectal swab; rectal swab for PCR; Biological: saliva sample; for biocollection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion against SARS-CoV2 in children	serology	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of Ab antiN and Ab anti-S1/2	Serology in children	at inclusion
Neutralization activity	Serology in children	at inclusion
Positive qPCR in children	in children, qualitative and quantitative measure , in nasopharynx, saliva and stool	at inclusion
correlation between different Ab and qPCR and neutralization activity	in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum	at inclusion
Protective immunity	Serology, measure of Ab in PCR positive children	Day 3
Protective immunity	Serology, measure of Ab in PCR positive children	Day 7
Protective immunity	Serology, measure of Ab in PCR positive children	Day 15
Protective immunity	Serology, measure of Ab in PCR positive children	Day 45
Protective immunity	Serology, measure of Ab in PCR positive children	At 6 months
Protective immunity	Serology, measure of Ab in PCR positive children	At 12 months
Duration of viral carriage in stool, saliva and or nasopharynx	Sars-Cov2 PCR in PCR positive children	until 45 days if persistence of positive qPCR
Correlation between antibody profile and viral clearance	Serology in PCR positive children	until 45 days post onset
Ab profile and memory of immunity	Immune cells in positive PCR children	At Day 3
Ab profile and memory of immunity	Immune cells in positive PCR children	At Day 7
Ab profile and memory of immunity	Immune cells in positive PCR children	At Day 15
Ab profile and memory of immunity	Immune cells in positive PCR children	At Day 45
Ab profile and memory of immunity	Immune cells in positive PCR children	At 6 months
Ab profile and memory of immunity	Immune cells in positive PCR children	At 12 months
saliva biofluid characteristics of COVID-19 infected	viral content (qPCR and immunodetection); presence of IgG, M, and A	Until 1 year follow-up
Presence of the virus	In PCR positive children: nasopharynx, saliva, stool	Until 1 year follow-up
Reinfection	In PCR positive children: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus	Until 1 year follow-up
Transmission of the virus to the family	symptomatic, virological and serological follow-up	until 45 days follow-up
Immune response	In children COVID+ during the first wave :immune response few months after the infection	At inclusion
Mucosal immunity	In PCR positive children: Ab anti-SARS-cov2 in nasopharynx samples	Until 1 year follow-up
seroconversion against SARS-CoV2 in parents	Ancillary study: Serology in parents	at inclusion
Measure of Ab antiN and Ab anti-S1 and neutralization activity	Ancillary study: Serology in parents	at inclusion
Positive qPCR in parents	Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva	at inclusion
Correlation between different Ab and qPCR	Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum	at inclusion
Correlation between antibody profile and viral clearance	Ancillary study: Serology in PCR positive parents	until 45 days post onset
Ab profile and memory of immunity	Ancillary study: Immune cells in positive PCR parents	at Day 3
Ab profile and memory of immunity	Ancillary study: Immune cells in positive PCR parents	at Day 7
Ab profile and memory of immunity	Ancillary study: Immune cells in positive PCR parents	at Day 15
Ab profile and memory of immunity	Ancillary study: Immune cells in positive PCR parents	at Day 45
Ab profile and memory of immunity	Ancillary study: Immune cells in positive PCR parents	at 6 months
Ab profile and memory of immunity	Ancillary study: Immune cells in positive PCR parents	at 12 months
Saliva biofluid characteristics of COVID-19 infected	in positive PCR parents: viral content (qPCR and immunodetection); presence of IgG, M, and A	Until 1 year follow-up
Presence of the virus	in positive PCR parents: nasopharynx, saliva	Until 45 days follow-up
Mucosal immunity	in positive PCR parents: Ab anti-SARS-cov2 in nasopharynx samples	Until 1 year follow-up
Reinfection	in positive PCR parents: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus	Until 1 year follow-up

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Institut Pasteur; Commissariat A L'energie Atomique
• Investigators: Principal Investigator: Isabelle SERMET-GAUDELUS, MD, PhD, Assistance Publique-Hôpitaux de Pars

Publications and helpful links

General Publications

• Delaunay-Moisan A, Guilleminot T, Semeraro M, Briand N, Bader-Meunier B, Berthaud R, Morelle G, Quartier P, Galeotti C, Basmaci R, Benoist G, Gajdos V, Lorrot M, Rifai M, Crespin M, M'Sakni Z, Padavia F, Savetier-Leroy C, Lorenzi M, Maurin C, Behillil S, de Pontual L, Elenga N, Bouazza N, Moltrecht B, van der Werf S, Leruez-Ville M, Sermet-Gaudelus I. Saliva for molecular detection of SARS-CoV-2 in pre-school and school-age children. Environ Microbiol. 2022 Oct;24(10):4725-4737. doi: 10.1111/1462-2920.16151. Epub 2022 Aug 12.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): May 24, 2022

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Child; COVID-19 infection; immune response; healthy carrier
• 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: APHP200467; 2020-A00999-30 (Registry Identifier: 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