COVIMMUNE 2 - Study of the incidence of SARS-CoV-2 infection in the Alpes-Maritimes administrative department based on the analysis of specific humoral and cellular response while easing lockdown restrictions

Head :
SEITZ-POLSKI Barbara, laboratoire d'Immunologie hôpital Archet 1

Last update : 06/09/2021 | Version : 1 | ID : 73574

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
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General
Identification
Detailed name Study of the incidence of SARS-CoV-2 infection in the Alpes-Maritimes administrative department based on the analysis of specific humoral and cellular response while easing lockdown restrictions
Sign or acronym COVIMMUNE 2
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation 2020-A01677-32
General Aspects
Medical area Biology
Immunology
Infectious diseases
Study in connection with Covid-19 Yes
Pathology (details) Humoral and cellular immune response to SARS-CoV-2
Health determinants Geography
Lifestyle and behavior
Occupation
Pollution
Social and psychosocial factors
Keywords easing of lockdown restrictions, interferon, SARS-CoV-2 COVID-19 Serology, immunovirology, incidence
Scientific investigator(s) (Contact)
Name of the director SEITZ-POLSKI
Surname Barbara
Address Hôpital de l'Archet 1
BP 3079
151 ROUTE ST ANTOINE DE GINESTIERE
06202 NICE CEDEX 3
Phone 0492035990
Email seitz-polski.b@chu-nice.fr
Unit laboratoire d'Immunologie hôpital Archet 1
Organization Nice University Hospital
Collaborations
Participation in projects, networks and consortia Yes
Details Department of Public Health - Nice University Hospital
Others Alpes-Maritimes Administrative Departmental Council
Funding
Funding status Public
Details Alpes-Maritimes Administrative Departmental Council, Regional Council, Nice University Hospital Research Unit
Governance of the database
Sponsor(s) or organisation(s) responsible Nice University Hospital
Organisation status Public
Presence of scientific or steering committees Yes
Labelling and database evaluation Nice University Hospital
Additional contact
Name of the contact ALLOUCHE
Surname Jonathan
Address Hôpital de l'Archet 1
BP 3079
151 ROUTE ST ANTOINE DE GINESTIERE
06202 NICE CEDEX 3
Email allouche.j@chu-nice.fr
Organization Department of Public Health, Nice University Hospital
Name of the contact Zorzi
Surname Kévin
Address Hôpital Pasteur 1
CHU de Nice
Phone 0492037917
Email zorzi.k@chu-nice.fr
Organization Nice University Hospital Clinical Research
Name of the contact PRADIER
Surname Christian
Address Hôpital de l'Archet 1
BP 3079
151 ROUTE ST ANTOINE DE GINESTIERE
06202 NICE CEDEX 3
Phone 0492035630
Email pradier.c@chu-nice.fr
Organization Department of Public Health, Nice University Hospital
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health institutions and services
A population file
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Prospective recruitment of healthy adult volunteers for COVID-19 exposed daily to SARS-CoV-2 from 11 May 2020 (not under lockdown restrictions), in a hospital setting (Nice University Hospital) and non-hospital setting (administrative department council officers, municipal officers).
Database objective
Main objective Determine the incidence of SARS-CoV-2 infection, over an 18-month period after the end of the first lockdown in a group of subjects whose professions involve contact with the general public.
Determine the risk of re-infection after initial infection with SARS-CoV-2 confirmed by a positive serology test.
Inclusion criteria Any healthy adult volunteers, exposed to the general public from 11 May 2020, informed of the study via partner institutions (06 Administrative Department Council), registered with a social security scheme.
Population type
Age Adolescence (13 to 18 years)
Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered General population
Pathology
Gender Male
Woman
Geography area Departmental
French regions covered by the database Provence - Alpes - Côte d'Azur
Detail of the geography area Alpes-Maritimes
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2020
Date of last collection (YYYY or MM/YYYY) 2022
Size of the database
Size of the database (number of individuals) [500-1000[ individuals
Details of the number of individuals Approximately 560
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Paraclinical data
Biological data
Administrative data
Clinical data (detail) Medical registration
Details of collected clinical data Clinical examination at inclusion
Declarative data (detail) Paper self-questionnaire
Face to face interview
Details of collected declarative data Self-administered questionnaire and in-person interview at inclusion
Paraclinical data (detail) Anthropometric data
Biological data (detail) Blood sample: Anti-SARS-CoV-2 IgA and IgG serology, QuantiFERON Monitor
Administrative data (detail) Gender, age, date and place of birth, marital status, number of children, most recent qualification
Presence of a biobank Yes
Contents of biobank Serum
Plasma
Others
Details of biobank content Other: Stimulated cell supernatant
Health parameters studied Health event/morbidity
Quality of life/health perception
Quality of life/perceived health (detail) Self-assessment of general state of health, self-assessment of stress level
Procedures
Data collection method Self-administered paper questionnaire, in-person interview, clinical examination and blood sample
Quality procedure(s) used Verification of electronic data entry. Database data management with consistency tests. Patients are informed of the use of their data.
Participant monitoring Yes
Monitoring procedures Monitoring by contact with the participant (mail, e-mail, telephone etc.)
Monitoring by convocation of the participant
Details on monitoring of participants Follow-up duration 5 years after inclusion. Possibility of correspondence via a secure messaging platform. Invitation by email and electronic platform for the visits at 6 months and 12 months after inclusion. Annual self-administered questionnaire sent out via a secure messaging platform 24, 36, 48 and 60 months after inclusion.
Links to administrative sources No
Promotion and access
Promotion
Link to the document https://clinicaltrials.gov/ct2/show/NCT04429594
Description Details of the study on Clinical Trial
Link to the document https://pubmed.ncbi.nlm.nih.gov/33585507/
Description Severe COVID-19 and evasion of interferon response
Link to the document https://pubmed.ncbi.nlm.nih.gov/33585509/
Description Humoral and cellular response to SARS-CoV-2 infection in exposed nursing staff at Nice University Hospital
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