Incidence of Covid-19 in School Children (COVIDECOLE)

May 22, 2020 updated by: Fondation Lenval

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France
        • Hôpitaux Pédiatrique de Nice CHU Lenval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: RT-PCR Covid-19
Diagnostic test: RT-PCR Covid-19
estimation of the prevalence of positive rt-PCR in school children during the pandemic period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of the prevalence of positive real-time-polymerase chain reaction (rt-PCR) in school children during the pandemic period in Nice
Time Frame: at 42 days
measure by two rt-PCR COVID-19 tests regardless the serological status of the child
at 42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of the serological prevalence of the Covid-19 infection
Time Frame: at inclusion and at 42 days
measure by two serological COVID-19 test (IgG and/or IgM)
at inclusion and at 42 days
evaluation of the COVID-19 reinfection among seropositive children at the inclusion time
Time Frame: at inclusion and at 42 days
measure by two serological COVID-19 test (IgG and/or IgM)
at inclusion and at 42 days
evaluation of the prevalence of positive rt-PCR of other respiratory viruses (including others coronavirus)
Time Frame: at 42 days
positivity of rt-PCR test for other viruses (adenovirus, metapneumovirus, picornavirus, respiratory syncytial virus, influenza et parainfluenza and other coronavirus strains)
at 42 days
comparison of inflammatory response level between different coronavirus strains
Time Frame: at 42 days
measure of level of the two inflammation biomarkers (IFIT1 interferon and CCL8)
at 42 days
Estimation of medico-social risk factors associated with COVID-19 infection
Time Frame: at 42 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Lenval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-HPNCL-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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