Hôpital necker Enfants-Malades
Paris, 75015, France
NCT Number: NCT04355533
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.
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Notify Me7 day and older
All sexes
Interventional
Not applicable
Paris, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
volume according to child weight
nasopharyngeal swab for PCR
rectal swab for PCR
for biocollection
Time frame: at inclusion
serology
Time frame: at inclusion
Serology in children
Time frame: at inclusion
Serology in children
Time frame: at inclusion
in children, qualitative and quantitative measure , in nasopharynx, saliva and stool
Time frame: at inclusion
in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum
Time frame: Day 3
Serology, measure of Ab in PCR positive children
Time frame: Day 7
Serology, measure of Ab in PCR positive children
Time frame: Day 15
Serology, measure of Ab in PCR positive children
Time frame: Day 45
Serology, measure of Ab in PCR positive children
Time frame: At 6 months
Serology, measure of Ab in PCR positive children
Time frame: At 12 months
Serology, measure of Ab in PCR positive children
Time frame: until 45 days if persistence of positive qPCR
Sars-Cov2 PCR in PCR positive children
Time frame: until 45 days post onset
Serology in PCR positive children
Time frame: At Day 3
Immune cells in positive PCR children
Time frame: At Day 7
Immune cells in positive PCR children
Time frame: At Day 15
Immune cells in positive PCR children
Time frame: At Day 45
Immune cells in positive PCR children
Time frame: At 6 months
Immune cells in positive PCR children
Time frame: At 12 months
Immune cells in positive PCR children
Time frame: Until 1 year follow-up
viral content (qPCR and immunodetection); presence of IgG, M, and A
Time frame: Until 1 year follow-up
In PCR positive children: nasopharynx, saliva, stool
Time frame: Until 1 year follow-up
In PCR positive children: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus
Time frame: until 45 days follow-up
symptomatic, virological and serological follow-up
Time frame: At inclusion
In children COVID+ during the first wave :immune response few months after the infection
Time frame: Until 1 year follow-up
In PCR positive children: Ab anti-SARS-cov2 in nasopharynx samples
Time frame: at inclusion
Ancillary study: Serology in parents
Time frame: at inclusion
Ancillary study: Serology in parents
Time frame: at inclusion
Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva
Time frame: at inclusion
Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum
Time frame: until 45 days post onset
Ancillary study: Serology in PCR positive parents
Time frame: at Day 3
Ancillary study: Immune cells in positive PCR parents
Time frame: at Day 7
Ancillary study: Immune cells in positive PCR parents
Time frame: at Day 15
Ancillary study: Immune cells in positive PCR parents
Time frame: at Day 45
Ancillary study: Immune cells in positive PCR parents
Time frame: at 6 months
Ancillary study: Immune cells in positive PCR parents
Time frame: at 12 months
Ancillary study: Immune cells in positive PCR parents
Time frame: Until 1 year follow-up
in positive PCR parents: viral content (qPCR and immunodetection); presence of IgG, M, and A
Time frame: Until 45 days follow-up
in positive PCR parents: nasopharynx, saliva
Time frame: Until 1 year follow-up
in positive PCR parents: Ab anti-SARS-cov2 in nasopharynx samples
Time frame: Until 1 year follow-up
in positive PCR parents: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus
Assistance Publique - Hôpitaux de Paris
Other
Seroprevalence and Antibody Profiling Against SARS-CoV2 in Children and Their Parents
Acronym: PED-COVID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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