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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Recruitment Status : Withdrawn (Human Subjects Protection Review: submitted, denied)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

Tracking Information
First Submitted Date  ICMJE May 4, 2020
First Posted Date  ICMJE May 6, 2020
Last Update Posted Date May 27, 2020
Estimated Study Start Date  ICMJE May 15, 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incidence of Covid-19 in School Children
Official Title  ICMJE Incidence of Covid-19 in School Children During the Pandemic Period in Nice
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Infection; Viral, Coronavirus
Intervention  ICMJE Diagnostic Test: RT-PCR Covid-19
estimation of the prevalence of positive rt-PCR in school children during the pandemic period
Study Arms  ICMJE RT-PCR Covid-19
Intervention: Diagnostic Test: RT-PCR Covid-19
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 22, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2020)
914
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04377737
Other Study ID Numbers  ICMJE 20-HPNCL-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondation Lenval
Study Sponsor  ICMJE Fondation Lenval
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fondation Lenval
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP