COV1APHP - Collection of blood samples from individuals having developed SARS CoV-2 infection

Head :
Launay Odile

Last update : 04/22/2021 | Version : 1 | ID : 73506

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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
Access
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General
Identification
Detailed name Collection of blood samples from individuals having developed SARS CoV-2 infection
Sign or acronym COV1APHP
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation ID-RCB: 2020-A00915-34
General Aspects
Medical area Infectious diseases
Study in connection with Covid-19 Yes
Pathology (details) Recovered SARS-CoV-2 infection
Scientific investigator(s) (Contact)
Name of the director Launay
Surname Odile
Address CIC 1417 Cochin-Pasteur
Hôpital Cochin, Bâtiment Lavoisier
27 Rue du Faubourg Saint-Jacques
75014 PARIS
Collaborations
Participation in projects, networks and consortia No
Funding
Governance of the database
Sponsor(s) or organisation(s) responsible BIOMERIEUX
Organisation status
Additional contact
Name of the contact PIGA
Surname Nadia
Address BioMérieux SA
Immunoassays Research & Development
Chemin de l'Orme
69280 MARCY L'ETOILE
Email nadia.piga@biomerieux.com
Main features
Type of database
Type of database Health relevant administrative databases
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is is made on the basis of: Another treatment or procedure
Database recruitment is carried out as part of an interventional study Yes
Details Performed at individual level
Additional information regarding sample selection. Individuals having developed SARS-CoV-2 infection
Database objective
Main objective This study aims to develop prototype tests for the in vitro diagnostic serology of SARS-CoV-2
Inclusion criteria Healthcare personnel or patient, having recovered from COVID-19
Individuals having developed typical symptoms of SARS-CoV-2, with a result confirmed by a PCR laboratory test on a nasopharyngeal swab, and with a blood sample taken at least 10 days after onset of symptoms
Adults
Individuals having been duly informed and signed the informed consent form
Affiliated with a French social security system
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 Regional
French regions covered by the database Île-de-France
Detail of the geography area APHP institutions
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2020
Date of last collection (YYYY or MM/YYYY) 2020
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 100
Data
Database activity Data collection completed
Type of data collected Clinical data
Administrative data
Details of collected clinical data Date of onset of COVID-19 symptoms, clinical signs, name of confirmation PCR test, date of PCR test
Administrative data (detail) Age, gender
Procedures
Data collection method Data collection form (1 form per participant) completed by the CIC (clinical investigation center), scanned, then transferred to BioMérieux via a secure file-sharing platform (Coltshare)
Participant monitoring Yes
Monitoring procedures Monitoring by contact with the participant (mail, e-mail, telephone etc.)
Details on monitoring of participants Contact 3 days (+/- 1 day) after the blood sample, to check that the venous puncture site is healthy
Links to administrative sources No
Promotion and access
Promotion
Access

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