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Incidence of Covid-19 in School Children (COVIDECOLE)

Primary Purpose

Infection; Viral, Coronavirus

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RT-PCR Covid-19
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infection; Viral, Coronavirus focused on measuring Covid19, Incidence, School, Pandemia, Children

Eligibility Criteria

3 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpitaux Pédiatrique de Nice CHU Lenval

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

RT-PCR Covid-19

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

evaluation of the serological prevalence of the Covid-19 infection
measure by two serological COVID-19 test (IgG and/or IgM)
evaluation of the COVID-19 reinfection among seropositive children at the inclusion time
measure by two serological COVID-19 test (IgG and/or IgM)
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)
comparison of inflammatory response level between different coronavirus strains
measure of level of the two inflammation biomarkers (IFIT1 interferon and CCL8)
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).

Full Information

First Posted
May 4, 2020
Last Updated
May 22, 2020
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT04377737
Brief Title
Incidence of Covid-19 in School Children
Acronym
COVIDECOLE
Official Title
Incidence of Covid-19 in School Children During the Pandemic Period in Nice
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Human Subjects Protection Review: submitted, denied
Study Start Date
May 15, 2020 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection; Viral, Coronavirus
Keywords
Covid19, Incidence, School, Pandemia, Children

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RT-PCR Covid-19
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
RT-PCR Covid-19
Intervention Description
estimation of the prevalence of positive rt-PCR in school children during the pandemic period
Primary Outcome Measure Information:
Title
evaluation of the prevalence of positive real-time-polymerase chain reaction (rt-PCR) in school children during the pandemic period in Nice
Description
measure by two rt-PCR COVID-19 tests regardless the serological status of the child
Time Frame
at 42 days
Secondary Outcome Measure Information:
Title
evaluation of the serological prevalence of the Covid-19 infection
Description
measure by two serological COVID-19 test (IgG and/or IgM)
Time Frame
at inclusion and at 42 days
Title
evaluation of the COVID-19 reinfection among seropositive children at the inclusion time
Description
measure by two serological COVID-19 test (IgG and/or IgM)
Time Frame
at inclusion and at 42 days
Title
evaluation of the prevalence of positive rt-PCR of other respiratory viruses (including others coronavirus)
Description
positivity of rt-PCR test for other viruses (adenovirus, metapneumovirus, picornavirus, respiratory syncytial virus, influenza et parainfluenza and other coronavirus strains)
Time Frame
at 42 days
Title
comparison of inflammatory response level between different coronavirus strains
Description
measure of level of the two inflammation biomarkers (IFIT1 interferon and CCL8)
Time Frame
at 42 days
Title
Estimation of medico-social risk factors associated with COVID-19 infection
Description
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).
Time Frame
at 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hôpitaux Pédiatrique de Nice CHU Lenval
City
Nice
Country
France

12. IPD Sharing Statement

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Incidence of Covid-19 in School Children

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