NCT04413968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2020

Completed
Last Updated

October 26, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

June 2, 2020

Last Update Submit

October 23, 2020

Conditions

CoronavirusCoronavirus InfectionCovid19Sars-CoV2

Keywords

NurseryChild

Outcome Measures

Primary Outcomes (1)

  • Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period

    Proportion of children with a positive rapid serological test (presence of anti-SARS-CoV2 antibodies (IgM or IgG)).

    Day of intervention (1 day)

Study Arms (1)

Interventional

EXPERIMENTAL

nasopharyngeal and blood sample

Diagnostic Test: Rapid detection testDiagnostic Test: Nasopharyngeal swabDiagnostic Test: Stool collection

Interventions

Rapid detection testDIAGNOSTIC_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

Interventional
Nasopharyngeal swabDIAGNOSTIC_TEST

Posterior nasopharyngeal swabbing in children

Interventional
Stool collectionDIAGNOSTIC_TEST

Stool collection in children

Interventional

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Population 1 :
  • Consent of the holders of parental authority
  • Affiliated to a social security system or entitled person
  • Population 2 :
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hopital Avicenne

Bobigny, 93000, France

Location

Hôpital Jean Verdier - Service de Pédiatrie

Bondy, 93143, France

Location

Hôpital Jean Verdier

Bondy, 93143, France

Location

Hôpital Antoine béclère

Clamart, 92140, France

Location

Hôpital Louis Mourier

Colombes, 92700, France

Location

CH intercommunal de Créteil

Créteil, 94000, France

Location

Hôpital Annecy Genevois

Épagny, France

Location

Hôpital Andé Mignot

Le Chesnay, 78150, France

Location

Hôpital Trousseau

Paris, 75012, France

Location

Hôpital Robert debré

Paris, 75019, France

Location

CHU de Rouen

Rouen, 76000, France

Location

Related Publications (1)

  • 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.

    PMID: 33571450DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Eric LACHASSINNE, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Cross-sectional, multi-center, non-randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 4, 2020

Study Start

June 2, 2020

Primary Completion

July 2, 2020

Study Completion

October 2, 2020

Last Updated

October 26, 2020

Record last verified: 2020-05

Locations

FR(11)