COVID-19 Infection and Transmission in Exposed, Confined and Community-based Infants (COVIDOCRECHE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04413968|
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : October 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Coronavirus Infection Covid19 Sars-CoV2||Diagnostic Test: Rapid detection test Diagnostic Test: Nasopharyngeal swab Diagnostic Test: Stool collection||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cross-sectional, multi-center, non-randomized study|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 2, 2020|
|Actual Primary Completion Date :||July 2, 2020|
|Actual Study Completion Date :||October 2, 2020|
nasopharyngeal and blood sample
Diagnostic Test: 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
Diagnostic Test: Nasopharyngeal swab
Posterior nasopharyngeal swabbing in children
Diagnostic Test: Stool collection
Stool collection in children
- 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)).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413968
|Bobigny, France, 93000|
|Hôpital Jean Verdier - Service de Pédiatrie|
|Bondy, France, 93143|
|Hôpital Jean Verdier|
|Bondy, France, 93143|
|Hôpital Antoine béclère|
|Clamart, France, 92140|
|Hôpital Louis Mourier|
|Colombes, France, 92700|
|CH intercommunal de Créteil|
|Créteil, France, 94000|
|Hôpital Andé Mignot|
|Le Chesnay, France, 78150|
|Paris, France, 75012|
|Hôpital Robert debré|
|Paris, France, 75019|
|CHU de Rouen|
|Rouen, France, 76000|
|Hôpital Annecy Genevois|
|Principal Investigator:||Eric LACHASSINNE, MD||Assistance Publique - Hôpitaux de Paris|