Clinical trial NCT04475211: LILLE COVID RESEARCH NETWORK (Covid-19)
Official title: Predictors of Mortality at Day 28 of Patients Treated at Lille University Hospital for COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV2
Keywords: COVID-19
fatality rate
Inflammatory and autoimmune processes
severity
clinical features
diagnostic (qRT-PCR or serology) methods
thrombosis
co-infection
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult "suspect patient", "possible case", "probable case" or "confirmed case" of an SARS-CoV-2 infection admitted to Lille University Hospital.

Brief summary: The Lille University Hospital developped a research objective common to all the services which took care of patients, "suspected patient", "possible case", "probable case" or "confirmed case" infected with SARS-CoV-2 by constituting a prospective and a retrospective observational cohort which allowed pooling and sharing the resources and data collected. In the next two years the prospective cohort will allow to continue inclusions in a standardized way mainly for the constitution of a negative control group (excluded cases), to collect biological samples which had not been collected in the retrospective cohort so that the pathophysiology of the COVID-19 will be better apprehended as for example the inflammatory response to the viral infection. Finally in case of a second epidemic wave in the Hauts De France, it seems essential to have a defined research protocol which had already received all the necessary authorizations to guarantee cutting-edge (or quality ) research in a center like the Lille University Hospital.The aim objective of this study is to identify predictive factors of mortality to day 28 infection to SARS-CoV-2 for patients under medical care for the COVID-19 in the Lille University Hospital thanks to the constitution of an epidemiological, clinical, biological, immunological, genetic, microbiological, anatomopathologic, radiological, therapeutic database and so record the results of functional exploration exams.

Detailed description: This is a retrospective and prospective observational monocentric cohort study designed to identify predictors of mortality on day 28 in patients treated at the Lille University Hospital for COVID-19.

Eligibility criteria: Inclusion Criteria:

* All adult "suspect patient", "possible case", "probable case" or "confirmed case" of an SARS-CoV-2 infection admitted to Lille University Hospital.

Exclusion Criteria:

* Minor patient Patient under guardianship or curatorship Refusal to participate in the study Patient for whom the collection of genetic non-opposition or consent is impossible because of a language barrier with the patient himself or herself or with his or her trusted person or close family.

Patient for whom the collection of genetic non-opposition or consent is impossible because of his or her state of health at the time of inclusion in the study and for whom the trusted person or close family member opposes participation in the study.

Translated with www.DeepL.com/Translator (free version)

Primary outcomes:
measure: Number of patients "confirmed cases" of SARS-CoV-2 infection who died at D28 of inclusion
timeFrame: At 28 days
Secondary outcomes:
measure: Correlation between Infection characteristics of patients at inclusion and all predictors for Covid-19
timeFrame: At inclusion (day 0)
measure: Correlation between evolution infection characteristics of patients during stay of hospitalisation and all predictors for Covid-19
timeFrame: At inclusion ( day 0) ,at day 1 , day3±1, Day 5±1, day 7±1, day 9±2, day14±2, day30±3, at months 3±7 days and at months6±7days or until death
measure: Positivity for Covid-19 patients performed and all predictors for Covid-19
timeFrame: At inclusion (day 0)
measure: Correlation between hospitalisation and all predictors for Covid-19
timeFrame: At inclusion( Day 0)
measure: Correlation between risk factors measured at D0 for severe CoV-2 SARS infection and all predictors for Covid-19
timeFrame: At 28 day
measure: Correlation between overall survival at Day 28 and all predictors for Covid-19
timeFrame: At 28 day
measure: Cumulative incidence of at least one complication related to COVID 19
timeFrame: during hospitalization or during outpatient follow-up of "confirmed case" patients at Lille University Hospital (maximum observation period 6 months).
measure: Cumulative incidence of the thrombosis complication related to COVID 19
timeFrame: during hospitalization or during outpatient follow-up of "confirmed case" patients at Lille University Hospital (maximum observation period 6 months).
measure: All type of co-infections
timeFrame: At 6 months
measure: Alteration of microbiota
timeFrame: At 6 months
measure: Biobanking for further analyses such as SARS-CoV2 studies
timeFrame: At 6 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chr Lille
Study officials:
affiliation: University Hospital, Lille
name: Marie-Charlotte CHOPIN, MD
role: PRINCIPAL_INVESTIGATOR
References: