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Incidence of Covid-19 in School Children (COVIDECOLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377737
Recruitment Status : Withdrawn (Human Subjects Protection Review: submitted, denied)
First Posted : May 6, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

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


Condition or disease Intervention/treatment Phase
Infection; Viral, Coronavirus Diagnostic Test: RT-PCR Covid-19 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Incidence of Covid-19 in School Children During the Pandemic Period in Nice
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377737


Locations
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France
Hôpitaux Pédiatrique de Nice CHU Lenval
Nice, France
Sponsors and Collaborators
Fondation Lenval
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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT04377737    
Other Study ID Numbers: 20-HPNCL-02
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Lenval:
Covid19
Incidence
School
Pandemia
Children
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections