Back to resultsImmunity Against SARS-CoV2 in Children and Their Parents / COVID-19 (PED-COVID)
Primary Purpose
COVID-19 Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
serology test
nasopharyngeal swab
rectal swab
saliva sample
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19 Infection focused on measuring Child, COVID-19 infection, immune response, healthy carrier
Eligibility Criteria
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
Sites / Locations
- Hôpital necker Enfants-Malades
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Hospitalized children or consulting at hospital
Parents of one included child
Children with potential COVID disease during the first wave
Children SARS-coV2 positive
Person living under the same roof as children included in the study
Arm Description
Outcomes
Primary Outcome Measures
Seroconversion against SARS-CoV2 in children
serology
Secondary Outcome Measures
Measure of Ab antiN and Ab anti-S1/2
Serology in children
Neutralization activity
Serology in children
Positive qPCR in children
in children, qualitative and quantitative measure , in nasopharynx, saliva and stool
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
Protective immunity
Serology, measure of Ab in PCR positive children
Protective immunity
Serology, measure of Ab in PCR positive children
Protective immunity
Serology, measure of Ab in PCR positive children
Protective immunity
Serology, measure of Ab in PCR positive children
Protective immunity
Serology, measure of Ab in PCR positive children
Protective immunity
Serology, measure of Ab in PCR positive children
Duration of viral carriage in stool, saliva and or nasopharynx
Sars-Cov2 PCR in PCR positive children
Correlation between antibody profile and viral clearance
Serology in PCR positive children
Ab profile and memory of immunity
Immune cells in positive PCR children
Ab profile and memory of immunity
Immune cells in positive PCR children
Ab profile and memory of immunity
Immune cells in positive PCR children
Ab profile and memory of immunity
Immune cells in positive PCR children
Ab profile and memory of immunity
Immune cells in positive PCR children
Ab profile and memory of immunity
Immune cells in positive PCR children
saliva biofluid characteristics of COVID-19 infected
viral content (qPCR and immunodetection); presence of IgG, M, and A
Presence of the virus
In PCR positive children: nasopharynx, saliva, stool
Reinfection
In PCR positive children: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus
Transmission of the virus to the family
symptomatic, virological and serological follow-up
Immune response
In children COVID+ during the first wave :immune response few months after the infection
Mucosal immunity
In PCR positive children: Ab anti-SARS-cov2 in nasopharynx samples
seroconversion against SARS-CoV2 in parents
Ancillary study: Serology in parents
Measure of Ab antiN and Ab anti-S1 and neutralization activity
Ancillary study: Serology in parents
Positive qPCR in parents
Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva
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
Correlation between antibody profile and viral clearance
Ancillary study: Serology in PCR positive parents
Ab profile and memory of immunity
Ancillary study: Immune cells in positive PCR parents
Ab profile and memory of immunity
Ancillary study: Immune cells in positive PCR parents
Ab profile and memory of immunity
Ancillary study: Immune cells in positive PCR parents
Ab profile and memory of immunity
Ancillary study: Immune cells in positive PCR parents
Ab profile and memory of immunity
Ancillary study: Immune cells in positive PCR parents
Ab profile and memory of immunity
Ancillary study: Immune cells in positive PCR parents
Saliva biofluid characteristics of COVID-19 infected
in positive PCR parents: viral content (qPCR and immunodetection); presence of IgG, M, and A
Presence of the virus
in positive PCR parents: nasopharynx, saliva
Mucosal immunity
in positive PCR parents: Ab anti-SARS-cov2 in nasopharynx samples
Reinfection
in positive PCR parents: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus
Full Information
NCT ID
NCT04355533
First Posted
April 17, 2020
Last Updated
February 1, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Commissariat A L'energie Atomique, Institut Pasteur
1. Study Identification
Unique Protocol Identification Number
NCT04355533
Brief Title
Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19
Acronym
PED-COVID
Official Title
Seroprevalence and Antibody Profiling Against SARS-CoV2 in Children and Their Parents
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Commissariat A L'energie Atomique, Institut Pasteur
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infection
Keywords
Child, COVID-19 infection, immune response, healthy carrier
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1056 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hospitalized children or consulting at hospital
Arm Type
Experimental
Arm Title
Parents of one included child
Arm Type
Experimental
Arm Title
Children with potential COVID disease during the first wave
Arm Type
Experimental
Arm Title
Children SARS-coV2 positive
Arm Type
Experimental
Arm Title
Person living under the same roof as children included in the study
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
serology test
Intervention Description
volume according to child weight
Intervention Type
Biological
Intervention Name(s)
nasopharyngeal swab
Intervention Description
nasopharyngeal swab for PCR
Intervention Type
Biological
Intervention Name(s)
rectal swab
Intervention Description
rectal swab for PCR
Intervention Type
Biological
Intervention Name(s)
saliva sample
Intervention Description
for biocollection
Primary Outcome Measure Information:
Title
Seroconversion against SARS-CoV2 in children
Description
serology
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Measure of Ab antiN and Ab anti-S1/2
Description
Serology in children
Time Frame
at inclusion
Title
Neutralization activity
Description
Serology in children
Time Frame
at inclusion
Title
Positive qPCR in children
Description
in children, qualitative and quantitative measure , in nasopharynx, saliva and stool
Time Frame
at inclusion
Title
correlation between different Ab and qPCR and neutralization activity
Description
in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum
Time Frame
at inclusion
Title
Protective immunity
Description
Serology, measure of Ab in PCR positive children
Time Frame
Day 3
Title
Protective immunity
Description
Serology, measure of Ab in PCR positive children
Time Frame
Day 7
Title
Protective immunity
Description
Serology, measure of Ab in PCR positive children
Time Frame
Day 15
Title
Protective immunity
Description
Serology, measure of Ab in PCR positive children
Time Frame
Day 45
Title
Protective immunity
Description
Serology, measure of Ab in PCR positive children
Time Frame
At 6 months
Title
Protective immunity
Description
Serology, measure of Ab in PCR positive children
Time Frame
At 12 months
Title
Duration of viral carriage in stool, saliva and or nasopharynx
Description
Sars-Cov2 PCR in PCR positive children
Time Frame
until 45 days if persistence of positive qPCR
Title
Correlation between antibody profile and viral clearance
Description
Serology in PCR positive children
Time Frame
until 45 days post onset
Title
Ab profile and memory of immunity
Description
Immune cells in positive PCR children
Time Frame
At Day 3
Title
Ab profile and memory of immunity
Description
Immune cells in positive PCR children
Time Frame
At Day 7
Title
Ab profile and memory of immunity
Description
Immune cells in positive PCR children
Time Frame
At Day 15
Title
Ab profile and memory of immunity
Description
Immune cells in positive PCR children
Time Frame
At Day 45
Title
Ab profile and memory of immunity
Description
Immune cells in positive PCR children
Time Frame
At 6 months
Title
Ab profile and memory of immunity
Description
Immune cells in positive PCR children
Time Frame
At 12 months
Title
saliva biofluid characteristics of COVID-19 infected
Description
viral content (qPCR and immunodetection); presence of IgG, M, and A
Time Frame
Until 1 year follow-up
Title
Presence of the virus
Description
In PCR positive children: nasopharynx, saliva, stool
Time Frame
Until 1 year follow-up
Title
Reinfection
Description
In PCR positive children: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus
Time Frame
Until 1 year follow-up
Title
Transmission of the virus to the family
Description
symptomatic, virological and serological follow-up
Time Frame
until 45 days follow-up
Title
Immune response
Description
In children COVID+ during the first wave :immune response few months after the infection
Time Frame
At inclusion
Title
Mucosal immunity
Description
In PCR positive children: Ab anti-SARS-cov2 in nasopharynx samples
Time Frame
Until 1 year follow-up
Title
seroconversion against SARS-CoV2 in parents
Description
Ancillary study: Serology in parents
Time Frame
at inclusion
Title
Measure of Ab antiN and Ab anti-S1 and neutralization activity
Description
Ancillary study: Serology in parents
Time Frame
at inclusion
Title
Positive qPCR in parents
Description
Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva
Time Frame
at inclusion
Title
Correlation between different Ab and qPCR
Description
Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum
Time Frame
at inclusion
Title
Correlation between antibody profile and viral clearance
Description
Ancillary study: Serology in PCR positive parents
Time Frame
until 45 days post onset
Title
Ab profile and memory of immunity
Description
Ancillary study: Immune cells in positive PCR parents
Time Frame
at Day 3
Title
Ab profile and memory of immunity
Description
Ancillary study: Immune cells in positive PCR parents
Time Frame
at Day 7
Title
Ab profile and memory of immunity
Description
Ancillary study: Immune cells in positive PCR parents
Time Frame
at Day 15
Title
Ab profile and memory of immunity
Description
Ancillary study: Immune cells in positive PCR parents
Time Frame
at Day 45
Title
Ab profile and memory of immunity
Description
Ancillary study: Immune cells in positive PCR parents
Time Frame
at 6 months
Title
Ab profile and memory of immunity
Description
Ancillary study: Immune cells in positive PCR parents
Time Frame
at 12 months
Title
Saliva biofluid characteristics of COVID-19 infected
Description
in positive PCR parents: viral content (qPCR and immunodetection); presence of IgG, M, and A
Time Frame
Until 1 year follow-up
Title
Presence of the virus
Description
in positive PCR parents: nasopharynx, saliva
Time Frame
Until 45 days follow-up
Title
Mucosal immunity
Description
in positive PCR parents: Ab anti-SARS-cov2 in nasopharynx samples
Time Frame
Until 1 year follow-up
Title
Reinfection
Description
in positive PCR parents: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus
Time Frame
Until 1 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle SERMET-GAUDELUS, MD, PhD
Organizational Affiliation
Assistance Publique-Hôpitaux de Pars
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital necker Enfants-Malades
City
¨Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19
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