COVID-19 Infection and Transmission in Exposed, Confined and Community-based Infants
NCT ID: NCT04413968
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
600 participants
INTERVENTIONAL
2020-06-02
2020-10-02
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Interventional
nasopharyngeal and blood sample
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
Nasopharyngeal swab
Posterior nasopharyngeal swabbing in children
Stool collection
Stool collection in children
Interventions
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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
Nasopharyngeal swab
Posterior nasopharyngeal swabbing in children
Stool collection
Stool collection in children
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Month
ALL
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Eric LACHASSINNE, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hopital Avicenne
Bobigny, , France
Hôpital Jean Verdier - Service de Pédiatrie
Bondy, , France
Hôpital Jean Verdier
Bondy, , France
Hôpital Antoine béclère
Clamart, , France
Hôpital Louis Mourier
Colombes, , France
CH intercommunal de Créteil
Créteil, , France
Hôpital Annecy Genevois
Épagny, , France
Hôpital Andé Mignot
Le Chesnay, , France
Hôpital Trousseau
Paris, , France
Hôpital Robert debré
Paris, , France
CHU de Rouen
Rouen, , France
Countries
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References
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Lachassinne E, de Pontual L, Caseris M, Lorrot M, Guilluy C, Naud A, Dommergues MA, Pinquier D, Wannepain E, Hausherr E, Jung C, Gajdos V, Cohen R, Zahar JR, Brichler S, Basmaci R, Boelle PY, Bloch-Queyrat C, Aupiais C; COVIDOCRECHE collaborators. SARS-CoV-2 transmission among children and staff in daycare centres during a nationwide lockdown in France: a cross-sectional, multicentre, seroprevalence study. Lancet Child Adolesc Health. 2021 Apr;5(4):256-264. doi: 10.1016/S2352-4642(21)00024-9. Epub 2021 Feb 8.
Other Identifiers
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2020-A01540-39
Identifier Type: OTHER
Identifier Source: secondary_id
APHP200587
Identifier Type: -
Identifier Source: org_study_id