Viewing Study NCT04413968


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Study NCT ID: NCT04413968
Status: COMPLETED
Last Update Posted: 2020-10-26
First Post: 2020-06-02
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: COVID-19 Infection and Transmission in Exposed, Confined and Community-based Infants
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization:

Study Overview

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
Status: COMPLETED
Status Verified Date: 2020-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: COVIDOCRECHE
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).

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
2020-A01540-39 OTHER Registry ID : IDRCB View