- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04413968
COVID-19 Infection and Transmission in Exposed, Confined and Community-based Infants (COVIDOCRECHE)
Contamination and Transmission of the SARS-CoV-2 Virus in Exposed, Confined and Community-based Infants: A Cross-sectional, Multicentre, Interventional Seroprevalence Study
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bobigny, France, 93000
- Hopital Avicenne
-
Bondy, France, 93143
- Hôpital Jean Verdier
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Bondy, France, 93143
- Hôpital Jean Verdier - Service de Pédiatrie
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Clamart, France, 92140
- Hôpital Antoine Béclère
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Colombes, France, 92700
- Hopital Louis Mourier
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Créteil, France, 94000
- CH intercommunal de Créteil
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Le Chesnay, France, 78150
- Hôpital Andé Mignot
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Paris, France, 75019
- Hopital Robert Debre
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Paris, France, 75012
- Hôpital Trousseau
-
Rouen, France, 76000
- CHU de Rouen
-
Épagny, France
- Hôpital Annecy Genevois
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional
nasopharyngeal and blood sample
|
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
Posterior nasopharyngeal swabbing in children
Stool collection in children
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)).
|
Day of intervention (1 day)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Eric LACHASSINNE, MD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP200587
- 2020-A01540-39 (Other Identifier: Registry ID : IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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