Incidence of Covid-19 in School Children

Infection; Viral, Coronavirus Clinical Trial

— COVIDECOLE  

Official title:

Incidence of Covid-19 in School Children During the Pandemic Period in Nice

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04377737
• Other study ID #: 20-HPNCL-02
• Status: Withdrawn
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: September 2020

Study information

• Verified date: May 2020
• Source: Fondation Lenval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Infection; Viral, Coronavirus
• Virus Diseases

Intervention

Diagnostic Test:
• RT-PCR Covid-19
estimation of the prevalence of positive rt-PCR in school children during the pandemic period

Locations

Country	Name	City	State
France	Hôpitaux Pédiatrique de Nice CHU Lenval	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of the prevalence of positive real-time-polymerase chain reaction (rt-PCR) in school children during the pandemic period in Nice	measure by two rt-PCR COVID-19 tests regardless the serological status of the child	at 42 days
Secondary	evaluation of the serological prevalence of the Covid-19 infection	measure by two serological COVID-19 test (IgG and/or IgM)	at inclusion and at 42 days
Secondary	evaluation of the COVID-19 reinfection among seropositive children at the inclusion time	measure by two serological COVID-19 test (IgG and/or IgM)	at inclusion and at 42 days
Secondary	evaluation of the prevalence of positive rt-PCR of other respiratory viruses (including others coronavirus)	positivity of rt-PCR test for other viruses (adenovirus, metapneumovirus, picornavirus, respiratory syncytial virus, influenza et parainfluenza and other coronavirus strains)	at 42 days
Secondary	comparison of inflammatory response level between different coronavirus strains	measure of level of the two inflammation biomarkers (IFIT1 interferon and CCL8)	at 42 days
Secondary	Estimation of medico-social risk factors associated with COVID-19 infection	measure of the medico-social relative risk associated with rt-PCR COVID-19 test positivity among : school level, gender, school type, day care facilities before 11th May, number of siblings, housing type, number of bedrooms, precariousness level, by score EPICES ( (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'examens de santé, means Assessment of precariousness and health inequalities in health examination centers).; Questionnaire of EPICES counts 11 items, the answer to each question is assigned a coefficient, the sum of the 11 answers gives the score EPICES. The score is continuous, it varies from 0 (lack of precariousness) to 100 (maximum precariousness).	at 42 days