Clinical trial NCT04377737: Incidence of Covid-19 in School Children
Official title: Incidence of Covid-19 in School Children During the Pandemic Period in Nice
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infection; Viral, Coronavirus
Keywords: Covid19
Incidence
School
Pandemia
Children
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. This is why measures to close schools and confine populations have been decreed in a large number of countries, including France. However, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children.

Investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children

Detailed description: The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. However, the role of the children in the spread of COVID-19 injection remains unclear.

Measures to close schools and to confine populations have been decreed in a large number of countries, including France. This decision has been based on epidemiologic data of other viral infections having droplet transmission and on data of Middle East Respiratory Syndrome-related coronavirus (MERS-CoV) asymptomatic portage.

Furthermore, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children.

Therefore, investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children.

This study will start on 11th May 2020, date of school reopening, in order to collect epidemiologic data about Covid-19 carriage among schoolers and to support governmental strategy for the new school year in September 2020.

Eligibility criteria: Inclusion Criteria:

Age ranging from 3 to 10 years old

* Children attending to school in Nice
* Informed consent
* French insurance subscribed

Exclusion Criteria:

* Refusal to participate from the parents or the child
* Bleeding disorders

Primary outcomes:
measure: evaluation of the prevalence of positive real-time-polymerase chain reaction (rt-PCR) in school children during the pandemic period in Nice
timeFrame: at 42 days
Secondary outcomes:
measure: evaluation of the serological prevalence of the Covid-19 infection
timeFrame: at inclusion and at 42 days
measure: evaluation of the COVID-19 reinfection among seropositive children at the inclusion time
timeFrame: at inclusion and at 42 days
measure: evaluation of the prevalence of positive rt-PCR of other respiratory viruses (including others coronavirus)
timeFrame: at 42 days
measure: comparison of inflammatory response level between different coronavirus strains
timeFrame: at 42 days
measure: Estimation of medico-social risk factors associated with COVID-19 infection
timeFrame: at 42 days
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux Pédiatrique de Nice CHU Lenval
Study officials:
References: