Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04490811
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2020-06-20
Brief Title:
Seroprevalence and Immunoprotection Against COVID-19 in Parisian Children
Sponsor:
Hôpital Necker-Enfants Malades
Organization:
Hôpital Necker-Enfants Malades
Study Overview
Official Title:
Seroprevalence and Immunoprotection Against SARS-CoV2 in Children Hospitalized in Paris
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AP-PEDCOVID
Brief Summary:
The paediatric population present mild or asymptomatic form of SARS-CoV-2 infection This study asses the frequency of patients with SARS-CoV2 Antibodies Ab seroprevalence and the neutralizing typology of those Ab immunoprotection in children from 7 days to 18 years of age hospitalized for no more than 4 days and whose clinical status requires blood sample regardless of the symptoms Patients are included on a given day after information before blood sampling performed as part of the care 500 µL of sera normally discarded will be kept to perform SARS-Cov2 serology
Detailed Description:
Background of the study
The fraction of undiagnosed cases is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV-2 emerging respiratory virus These subjects most often present themselves in benign or totally asymptomatic form although they are likely to spread the virus in the general population The containment strategy was implemented in France to reverse the exponential epidemic growth of infection
A crucial issue is the specific study of the paediatric population because the prevalence of symptomatic infections is low and children are mostly mild and under-diagnosed Children could frequently be asymptomatic carriers and act as a real reservoir for the spread of the virus In these sub-symptomatic carriers the viral load may be low and it is possible that PCR nasal tests may be defective The serological study is therefore essential because it will inform us about the speed and effectiveness of seroconversion and therefore about the immunoprotection of this subpopulation
The rationale for the study is that the proportion of children who have developed immunoprotection is decisive in defining measures to control the epidemic It is essential to assess the prevalence and typology of antibody responses in this population and to follow kinetics over time
The many emerging atypical forms and in particular the post-infectious kawasaki-like forms have a very particular immunopathological profile that provides information on the natural history of the disease
Main objectives of the study to assess the prevalence of seroconversion seroprevalence in a pediatric population sample to study the immunopathological profile of clinical forms attributed to SARS-CoV-2 infection
Design of the study Patients are included on a given day after information before blood sampling performed as part of the care 500 µL of sera normally discarded will be kept to perform SARS-Cov2 serology According to data currently collected in France 5 of children taken from symptoms are infected Given that nasopharyngeal testing is lacking in this pediatric population we anticipate an increase in the number of subjects who have been infected or have an ongoing infection at least 10 A sample of 800 subjects will therefore include at least 80 children with infection
A questionnaire will extract relevant variables to this project
Any symptoms of the index case or his family since December 2019 consistent with COVID-19
Comorbidities and treatment
Reason for hospitalization
History of contact case
Clinical signs on the day of collection
Result of RT-PCT SARS-CoV2 nasopharyngeal if made in the index case
The fraction of undiagnosed cases is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV-2 emerging respiratory virus These subjects most often present themselves in benign or totally asymptomatic form although they are likely to spread the virus in the general population The containment strategy was implemented in France to reverse the exponential epidemic growth of infection
A crucial issue is the specific study of the paediatric population because the prevalence of symptomatic infections is low and children are mostly mild and under-diagnosed Children could frequently be asymptomatic carriers and act as a real reservoir for the spread of the virus In these sub-symptomatic carriers the viral load may be low and it is possible that PCR nasal tests may be defective The serological study is therefore essential because it will inform us about the speed and effectiveness of seroconversion and therefore about the immunoprotection of this subpopulation
The rationale for the study is that the proportion of children who have developed immunoprotection is decisive in defining measures to control the epidemic It is essential to assess the prevalence and typology of antibody responses in this population and to follow kinetics over time
The many emerging atypical forms and in particular the post-infectious kawasaki-like forms have a very particular immunopathological profile that provides information on the natural history of the disease
Main objectives of the study to assess the prevalence of seroconversion seroprevalence in a pediatric population sample to study the immunopathological profile of clinical forms attributed to SARS-CoV-2 infection
Design of the study Patients are included on a given day after information before blood sampling performed as part of the care 500 µL of sera normally discarded will be kept to perform SARS-Cov2 serology According to data currently collected in France 5 of children taken from symptoms are infected Given that nasopharyngeal testing is lacking in this pediatric population we anticipate an increase in the number of subjects who have been infected or have an ongoing infection at least 10 A sample of 800 subjects will therefore include at least 80 children with infection
A questionnaire will extract relevant variables to this project
Any symptoms of the index case or his family since December 2019 consistent with COVID-19
Comorbidities and treatment
Reason for hospitalization
History of contact case
Clinical signs on the day of collection
Result of RT-PCT SARS-CoV2 nasopharyngeal if made in the index case
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None