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

NCT ID: NCT04413968

Last Updated: 2020-10-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-02

Study Completion Date

2020-10-02

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Coronavirus Coronavirus Infection Covid19 Sars-CoV2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cross-sectional, multi-center, non-randomized study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Interventional

nasopharyngeal and blood sample

Group Type EXPERIMENTAL

Rapid detection test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

Posterior nasopharyngeal swabbing in children

Stool collection

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Nasopharyngeal swab

Posterior nasopharyngeal swabbing in children

Intervention Type DIAGNOSTIC_TEST

Stool collection

Stool collection in children

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Hôpital Jean Verdier - Service de Pédiatrie

Bondy, , France

Site Status

Hôpital Jean Verdier

Bondy, , France

Site Status

Hôpital Antoine béclère

Clamart, , France

Site Status

Hôpital Louis Mourier

Colombes, , France

Site Status

CH intercommunal de Créteil

Créteil, , France

Site Status

Hôpital Annecy Genevois

Épagny, , France

Site Status

Hôpital Andé Mignot

Le Chesnay, , France

Site Status

Hôpital Trousseau

Paris, , France

Site Status

Hôpital Robert debré

Paris, , France

Site Status

CHU de Rouen

Rouen, , France

Site Status

Countries

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France

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.

Reference Type DERIVED
PMID: 33571450 (View on PubMed)

Other Identifiers

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2020-A01540-39

Identifier Type: OTHER

Identifier Source: secondary_id

APHP200587

Identifier Type: -

Identifier Source: org_study_id