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