ITMO public health
Last update : 01/12/2021 | Version : 1 | ID : 73581
| General | |
| Identification | |
| Detailed name | Comparison of results, feasibility and acceptability of molecular detection of CoV2-SARS between nasopharyngeal swab samples collected in virological transport media and salivary spit samples |
| Sign or acronym | COVISAL |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | 2020-A02009-30 |
| General Aspects | |
| Medical area |
Infectious diseases |
| Study in connection with Covid-19 |
Yes |
| Pathology (details) | COVID-19 |
| Keywords | covid-19, diagnosis |
| Scientific investigator(s) (Contact) | |
| Name of the director | DEMAR |
| Surname | Magalie |
| Address | Laboratoire Universitaire, Centre Hospitalier de Cayenne, Rue des Flamboyants, 97300, Cayenne, Guyane Française |
| Phone | 059439 53 59 |
| Unit | university laboratory |
| Organization | centre hospitalier de cayenne |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | centre hospitalo-Universitaire de Caen, centre national de référence des Virus respiratoires de Lyon |
| Funding | |
| Funding status |
Public |
| Details | ministerial covid fund |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Centre Hospitalier de Cayenne |
| Organisation status |
Public |
| Presence of scientific or steering committees |
No |
| Additional contact | |
| Name of the contact | nacher |
| Surname | mathieu |
| Address |
Centre d'investigation clinique INSERM 1424 Centre Hospitalier de Cayenne, Rue des Flamboyants, 973060, Cayenne Cedex, Guyane Française |
| Phone | 0594 39 50 50 |
| mathieu.nacher@ch-cayenne.fr | |
| Unit | CIC Inserm 1424 |
| Organization | Centre hospitalier de Cayenne |
| Main features | |
| Type of database | |
| Type of database |
Others |
| Study databases (details) |
Longitudinal study (except cohorts) |
| 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. | Recruitment of patients during the consultation to perform a diagnostic test for COVID-19 |
| Database objective | |
| Main objective | Comparison of the results obtained by the molecular detection of SARS-CoV2 in the 2 types of samples: nasopharyngeal swab taken from the virological transport medium and salivary spit. |
| Inclusion criteria |
Patient presenting to Cayenne Hospital with an indication to perform a COVID diagnostic test (symptomatology, contact case)
Men and women from 3 years to over 75 years old |
| Population type | |
| Age |
Early childhood (2 to 5 years) Childhood (6 to 13 years) 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 |
Guyane |
| Detail of the geography area | French Guiana |
| 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) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1159 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | clinical examination |
| Paraclinical data (detail) | date of symptoms, risk factors, hospitalization after sample collection, death |
| Biological data (detail) | sampling type |
| Administrative data (detail) | age, sex, reason for collection |
| Presence of a biobank |
Yes |
| Contents of biobank |
Fluids (saliva, urine, amniotic fluid, …) Others |
| Details of biobank content | nasopharyngeal swab, spit jar |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | interview, laboratory results |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) |
| Details on monitoring of participants | 14-day patient status by phone or by consulting the medical record |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access |
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