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

Primary Purpose

Coronavirus, Coronavirus Infection, Covid19

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rapid detection test
Nasopharyngeal swab
Stool collection
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronavirus focused on measuring Nursery, Child

Eligibility Criteria

1 Month - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hopital Avicenne
  • Hôpital Jean Verdier - Service de Pédiatrie
  • Hôpital Jean Verdier
  • Hôpital Antoine béclère
  • Hôpital Louis Mourier
  • CH intercommunal de Créteil
  • Hôpital Andé Mignot
  • Hôpital Trousseau
  • Hôpital Robert debré
  • CHU de Rouen
  • Hôpital Annecy Genevois

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

nasopharyngeal and blood sample

Outcomes

Primary Outcome Measures

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)).

Secondary Outcome Measures

Full Information

First Posted
June 2, 2020
Last Updated
October 23, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04413968
Brief Title
COVID-19 Infection and Transmission in Exposed, Confined and Community-based Infants
Acronym
COVIDOCRECHE
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 2, 2020 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, Coronavirus Infection, Covid19, Sars-CoV2
Keywords
Nursery, Child

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cross-sectional, multi-center, non-randomized study
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
nasopharyngeal and blood sample
Intervention Type
Diagnostic Test
Intervention Name(s)
Rapid detection test
Intervention Description
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
Intervention Name(s)
Nasopharyngeal swab
Intervention Description
Posterior nasopharyngeal swabbing in children
Intervention Type
Diagnostic Test
Intervention Name(s)
Stool collection
Intervention Description
Stool collection in children
Primary Outcome Measure Information:
Title
Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period
Description
Proportion of children with a positive rapid serological test (presence of anti-SARS-CoV2 antibodies (IgM or IgG)).
Time Frame
Day of intervention (1 day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric LACHASSINNE, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Hôpital Jean Verdier - Service de Pédiatrie
City
Bondy
ZIP/Postal Code
93143
Country
France
Facility Name
Hôpital Jean Verdier
City
Bondy
ZIP/Postal Code
93143
Country
France
Facility Name
Hôpital Antoine béclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
CH intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hôpital Andé Mignot
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Hôpital Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Robert debré
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Hôpital Annecy Genevois
City
Épagny
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33571450
Citation
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.
Results Reference
derived

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

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