ITMO public health
Last update : 05/05/2021 | Version : 1 | ID : 73660
| General | |
| Identification | |
| Detailed name | Predictive factors for mortality at D28 for patients managed at Lille University Hospital for COVID-19 |
| Sign or acronym | LICORNE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | n°ID-RCB : 2020-A01514-35 , NCT 04475211 |
| General Aspects | |
| Medical area |
Anesthesiology – Intensive care Biology Immunology Infectious diseases |
| Study in connection with Covid-19 |
Yes |
| Pathology (details) | "suspect patients", "possible cases", "probable cases" or "confirmed cases" of SARS-CoV-2 infection |
| Scientific investigator(s) (Contact) | |
| Name of the director | CHOPIN |
| Surname | Marie Charlotte |
| Organization | Lille University Hospital |
| Name of the director | DEPLANQUE |
| Surname | Dominique |
| Organization | CHU de Lille |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | i-site Lille |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Lille University Hospital |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Name of the contact | SCHWARB |
| Surname | Laurent |
| Address | Direction de la Recherche et de l’Innovation, <br>Bâtiment ex USN-B<br>6 rue du Pr Laguesse, <br>59037 Lille cedex<br> |
| Phone | 03.20.44.41.45 |
| drs.promotion@chru-lille.fr | |
| Organization | Lille University Hospital - Research Division Promotion Unit |
| Main features | |
| Type of database | |
| Type of database |
Others |
| Specify | Non-interventional clinical trial database corresponding to level 3 human research |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
The primary objective of this study is to identify the predictive factors for mortality at D28 of SARS-CoV-2 infection in patients managed for COVID-19 at Lille University Hospital, via the creation of an epidemiological, clinical, biological, immunological, genetic, microbiological, pathological, radiological and therapeutic database, indicating the results of functional tests.
NB: The analysis will exclude patients who are "confirmed cases" with serious SARS-CoV-2 infection managed in a conventional medicine department owing to the therapeutic limitations (TL) which existed prior to SARS-CoV-2 infection, due to incurable disease or underlying comorbidities. |
| Inclusion criteria | Any adult patient, "suspect patients", "possible cases", "probable cases" or "confirmed cases" of SARS-CoV-2 infection admitted to Lille University Hospital. |
| 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 |
Sick population |
| Pathology | B33 - Other viral diseases, not elsewhere classified |
| Gender |
Male Woman |
| Geography area |
Local |
| French regions covered by the database |
Nord - Pas-de-Calais Picardie |
| Detail of the geography area | Patients having attended an appointment or admitted to Lille University Hospital for suspected COVID |
| 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 | 1000 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Paraclinical data (detail) | Patient treatment path, epidemiological data |
| Biological data (detail) | standard care laboratory work-up, PCR diagnosis, other microbiological tests, |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma Blood cells isolated Fluids (saliva, urine, amniotic fluid, …) Tissues |
| Details of biobank content | EDTA, heparin and citrate serum and plasma, PBMC, nasopharyngeal samples, tissue taken from post-mortem examinations |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Retrospective collection for the first wave of COVID, the prospective collection from September 2020 |
| 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 | For patients followed up in an outpatient setting: data collection at D0, D9, D30, M3 and M6. - For hospitalised patients: data collection at D1, D3, D5, D7, D9, D14, D30, M3 and M6 |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | https://pubmed.ncbi.nlm.nih.gov/32708264/ |
| Description | Clinico-Biological Features and Clonal Hematopoiesis in Patients with Severe COVID-19 Endotheliopathy Is Induced by Plasma From Critically Ill Patients and Associated With Organ Failure in Severe COVID-19 Severe SARS-CoV-2 patients develop a higher specific T-cell response |
| Link to the document | https://pubmed.ncbi.nlm.nih.gov/32970476/ |
| Link to the document | https://pubmed.ncbi.nlm.nih.gov/33376594/ |
| Access |
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