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COVID-19 Infection and Transmission in Exposed, Confined and Community-based Infants (COVIDOCRECHE)

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ClinicalTrials.gov Identifier: NCT04413968
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to be of the same order of magnitude, but need to be confirmed by a biological technique. Children would be susceptible to infection but often asymptomatic.

Condition or disease Intervention/treatment Phase
Coronavirus Coronavirus Infection Covid19 Sars-CoV2 Diagnostic Test: Rapid detection test Diagnostic Test: Nasopharyngeal swab Diagnostic Test: Stool collection Not Applicable

Detailed Description:

SARS-CoV-2, an emerging respiratory virus of the coronavirus family, is responsible for a global pandemic of which Europe has become the epicentre. Infection with the virus causes a disease called COVID-19, whose expression most often includes cough, fever, fatigue, myalgia, anosmia, ageusia and gastrointestinal symptoms, and which can be complicated by severe pneumonia requiring resuscitation and which can lead to death. Morbidity and mortality are clearly age-related and while illness and hospitalisations occur in all age groups, deaths occur mostly in the older age groups.

In the absence of curative treatment and vaccination, the only real measures capable of slowing the progression of the disease are large-scale social distancing measures. In analogy to community-based viral epidemics such as seasonal influenza, children were initially considered a potential vector of transmission, which led to the preventive measure of school closures. In France, this closure came into force on 14 March 2020.

Children are considered to be little affected by the coronavirus-19 epidemic because even if screening strategies differ, they represent less than 3% of the cases confirmed in the various studies.

In a period of confinement and reduction in the number of children cared for, in a crèche for children of healthcare workers, in a context of proximity and high risk of cross transmission, the frequency of symptomatic and asymptomatic forms of SARS-Cov-2 in children and staff would be comparable to the general population.

We hypothesize a susceptibility to infection in children but low transmission, which should lead to a cumulative prevalence of infection among daycare staff comparable to that obtained in a sample of professionals who do not come into contact with children in their work (here hospital laboratory and administrative staff).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cross-sectional, multi-center, non-randomized study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contamination and Transmission of the SARS-CoV-2 Virus in Exposed, Confined and Community-based Infants: A Cross-sectional, Multicentre, Interventional Seroprevalence Study
Actual Study Start Date : June 2, 2020
Actual Primary Completion Date : July 2, 2020
Actual Study Completion Date : October 2, 2020


Arm Intervention/treatment
Experimental: Interventional
nasopharyngeal and blood sample
Diagnostic Test: Rapid detection test
Rapid serological test by taking 3 drops of blood from the fingertip via the TDR device (rapid detection test) for children, supervising nursery staff and hospital laboratory and administrative staff

Diagnostic Test: Nasopharyngeal swab
Posterior nasopharyngeal swabbing in children

Diagnostic Test: Stool collection
Stool collection in children




Primary Outcome Measures :
  1. Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period [ Time Frame: Day of intervention (1 day) ]
    Proportion of children with a positive rapid serological test (presence of anti-SARS-CoV2 antibodies (IgM or IgG)).



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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Population 1 :

  • Children of priority staff welcomed in the crèche during the period of confinement, i.e. from 15 March to 9 May, regardless of the length of time they are in the crèche during this period and their "symptomatic or not" status during this period or on the day of inclusion.
  • Consent of the holders of parental authority
  • Affiliated to a social security system or entitled person

Population 2 :

  • Nursery staff, regardless of their status/occupation and having had contact with the children during the period of confinement regardless of how long they have been in the nursery during this period and their "symptomatic or not" status during this period or on the day of inclusion.
  • Consent to participate
  • Affiliated to a social security system or entitled person

Population 3 :

  • Hospital staff not exposed to patients and/or children, with or without children in day care, working in the bacteriology, biochemistry and biological haematology laboratories or in an administrative department of the participating hospitals.
  • Affiliated to a social security system or entitled person

Exclusion Criteria:

Population 1 :

  • Refusal to sign consent by parents
  • Clinical condition requiring urgent medical assessment (attending physician or transfer to paediatric emergency)

Population 2 and 3 :

  • Refusal to sign consent for staff
  • Clinical condition requiring urgent medical evaluation

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): NCT04413968


Locations
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France
Hopital Avicenne
Bobigny, France, 93000
Hôpital Jean Verdier - Service de Pédiatrie
Bondy, France, 93143
Hôpital Jean Verdier
Bondy, France, 93143
Hôpital Antoine béclère
Clamart, France, 92140
Hôpital Louis Mourier
Colombes, France, 92700
CH intercommunal de Créteil
Créteil, France, 94000
Hôpital Andé Mignot
Le Chesnay, France, 78150
Hôpital Trousseau
Paris, France, 75012
Hôpital Robert debré
Paris, France, 75019
CHU de Rouen
Rouen, France, 76000
Hôpital Annecy Genevois
Épagny, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Eric LACHASSINNE, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04413968    
Other Study ID Numbers: APHP200587
2020-A01540-39 ( Other Identifier: Registry ID : IDRCB )
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: October 26, 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 Assistance Publique - Hôpitaux de Paris:
Nursery
Child
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases