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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00999-30 | Registry Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Commissariat A L'energie Atomique | OTHER_GOV |
| Institut Pasteur | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospitalized children or consulting at hospital | Experimental |
| |
| Parents of one included child | Experimental |
| |
| Children with potential COVID disease during the first wave | Experimental |
| |
| Children SARS-coV2 positive | Experimental |
| |
| Person living under the same roof as children included in the study | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| serology test | Biological | volume according to child weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion against SARS-CoV2 in children | serology | at inclusion |
| 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 |
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Inclusion Criteria:
For hospitalized children or consulting at hospital
For children with potential COVID disease during the first wave
Parent of the enrolled child
For children SARS-coV2 positive
For people living under the same roof of a child included in the study
Exclusion Criteria:
For hospitalized children or consulting at hospital
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle SERMET-GAUDELUS, MD, PhD | Assistance Publique-Hôpitaux de Pars | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital necker Enfants-Malades | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36065993 | Result | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012698 | Serologic Tests |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| URC-CIC Paris Descartes Necker Cochin |
| OTHER |
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| nasopharyngeal swab | Biological | nasopharyngeal swab for PCR |
|
| rectal swab | Biological | rectal swab for PCR |
|
| saliva sample | Biological | for biocollection |
|
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |