LICORNE - Predictive factors for mortality at D28 for patients managed at Lille University Hospital for COVID-19

Head :
CHOPIN Marie Charlotte
DEPLANQUE Dominique

Last update : 05/05/2021 | Version : 1 | ID : 73660

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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
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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
Email 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/
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