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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04355533

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other), Commissariat A L'energie Atomique (Other), Institut Pasteur (Industry)

1,000

Enrollment

Location

Arms

28.1

Anticipated Duration (Months)

35.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Infection	Biological: serology test Biological: nasopharyngeal swab Biological: rectal swab Biological: saliva sample	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jul 29, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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: School 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

Outcome Measures

Primary Outcome Measures

Seroconversion against SARS-CoV2 in children [at inclusion]
serology

Secondary Outcome Measures

Measure of Ab antiN and Ab anti-S1/2 [at inclusion]
Serology in children
Neutralization activity [at inclusion]
Serology in children
Positive qPCR in children [at inclusion]
in children, qualitative and quantitative measure , in nasopharynx, saliva and stool
correlation between different Ab and qPCR and neutralization activity [at inclusion]
in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum
Protective immunity [Day 7]
Serology, measure of Ab in PCR positive children
Protective immunity [Day 15]
Serology, measure of Ab in PCR positive children
Protective immunity [Day 30]
Serology, measure of Ab in PCR positive children
Protective immunity [At 6 months]
Serology, measure of Ab in PCR positive children
Protective immunity [At 12 months]
Serology, measure of Ab in PCR positive children
duration of viral carriage in stool, saliva and or nasopharynx [until 30 days post onset]
Sars-Cov2 PCR in PCR positive children
correlation between antibody profile and viral clearance [until 30 days post onset]
Serology in PCR positive children
Ab profile and memory of immunity [At Day 7]
Immune cells in positive PCR children
Ab profile and memory of immunity [At Day 15]
Immune cells in positive PCR children
Ab profile and memory of immunity [At Day 30]
Immune cells in positive PCR children
Ab profile and memory of immunity [At 6 months]
Immune cells in positive PCR children
Ab profile and memory of immunity [At 12 months]
Immune cells in positive PCR children
saliva biofluid characteristics of COVID-19 infected [Until 1 year follow-up]
viral content (qPCR and immunodetection); presence of IgG, M, and A
Presence of the virus [Until 1 year follow-up]
In PCR positive children: nasopharynx, saliva, stool
Reinfection [Until 1 year follow-up]
In PCR positive children: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus
Transmission of the virus to the family [until 45 days follow-up]
symptomatic, virological and serological follow-up
Immune response [At inclusion]
In children COVID+ during the first wave :immune response few months after the infection
Mucosal immunity [Until 1 year follow-up]
In PCR positive children: Ab anti-SARS-cov2 in nasopharynx samples
seroconversion against SARS-CoV2 in parents [at inclusion]
Ancillary study: Serology in parents
Measure of Ab antiN and Ab anti-S1 and neutralization activity [at inclusion]
Ancillary study: Serology in parents
Positive qPCR in parents [at inclusion]
Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva
correlation between different Ab and qPCR [at inclusion]
Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum
correlation between antibody profile and viral clearance [until 30 days post onset]
Ancillary study: Serology in PCR positive parents
Ab profile and memory of immunity [at Day 7]
Ancillary study: Immune cells in positive PCR parents
Ab profile and memory of immunity [at Day 15]
Ancillary study: Immune cells in positive PCR parents
Ab profile and memory of immunity [at Day 30]
Ancillary study: Immune cells in positive PCR parents
Ab profile and memory of immunity [at 6 months]
Ancillary study: Immune cells in positive PCR parents
Ab profile and memory of immunity [at 12 months]
Ancillary study: Immune cells in positive PCR parents
saliva biofluid characteristics of COVID-19 infected [Until 1 year follow-up]
in positive PCR parents: viral content (qPCR and immunodetection); presence of IgG, M, and A
Presence of the virus [Until 1 year follow-up]
in positive PCR parents: nasopharynx, saliva
Mucosal immunity [Until 1 year follow-up]
in positive PCR parents: Ab anti-SARS-cov2 in nasopharynx samples
Reinfection [Until 1 year follow-up]
in positive PCR parents: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Days and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

For hospitalized children or consulting at hospital

any child over 7 days old and under 17 years hospitalized since at most 4 days Or any child over 7 days old and under 17 years with a positive PCR at home, with a 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 school children SARS-coV2 positive

any child less then 18 years old
at school
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital necker Enfants-Malades	¨Paris		France	75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Commissariat A L'energie Atomique
Institut Pasteur

Investigators

Principal Investigator: Isabelle SERMET-GAUDELUS, MD, PhD, Assistance Publique-Hôpitaux de Pars

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT04355533

Other Study ID Numbers:

APHP200467
2020-A00999-30

First Posted:

Apr 21, 2020

Last Update Posted:

Mar 26, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Mar 26, 2021