Last update : 06/09/2021 | Version : 1 | ID : 73574
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 |
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 |
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 |
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 |
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 |
Access |
Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05