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

COVID-19 Infection Clinical Trial

— PED-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355533
• Other study ID #: APHP200467
• Secondary ID: 2020-A00999-30
• Status: Completed
• Phase: N/A
• Start date: July 29, 2020
• Est. completion date: May 24, 2022

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1056
• Est. completion date: May 24, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Days and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection

Intervention

Biological:
• serology test
volume according to child weight
• nasopharyngeal swab
nasopharyngeal swab for PCR
• rectal swab
rectal swab for PCR
• saliva sample
for biocollection

Locations

Country	Name	City	State
France	Hôpital necker Enfants-Malades	¨Paris

Sponsors (4)

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

Country where clinical trial is conducted

France, 

References & Publications (1)

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, — View Citation

Outcome

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