LILLE COVID RESEARCH NETWORK (Covid-19)

Study Overview
=================
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.

Official Title
-----------------
Predictors of Mortality at Day 28 of Patients Treated at Lille University Hospital for COVID-19

Conditions
-----------------
Sars-CoV2

Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients confirmed cases of SARS-CoV-2 infection who died at D28 of inclusion | Identify predictors of mortality at day 28 in patients treated at the Lille University Hospital for COVID-19 | At 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between Infection characteristics of patients at inclusion and all predictors for Covid-19 | Describe, at inclusion, the epidemiological, clinical, biological, immunological, genetic, microbiological, radiological, therapeutic characteristics and the results of functional explorations of patients hospitalized in our center with SARS-CoV-2 infection. | At inclusion (day 0) | 
| Correlation between evolution infection characteristics of patients during stay of hospitalisation and all predictors for Covid-19 | Describe the evolution of the characteristics the epidemiological, clinical, biological, immunological, genetic, microbiological, anatomopathological, radiological, therapeutic characteristics and the results of functional explorations of patients hospitalized in our center with SARS-CoV-2 infection. | 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 | 
| Positivity for Covid-19 patients performed and all predictors for Covid-19 | The diagnosis of disease is excluded or confirmed by qRT-PCR SARS-CoV-2 (respiratory samples, blood, stool...) and/or serology. | At inclusion (day 0) | 
| Correlation between hospitalisation and all predictors for Covid-19 | Identify epidemiological, clinical, radiological, biological, immunological and genetic predictors of hospitalization in patients with SARS-CoV-2 infection. | At inclusion( Day 0) | 
| Correlation between risk factors measured at D0 for severe CoV-2 SARS infection and all predictors for Covid-19 | Identify epidemiological, clinical, radiological, biological, immunological and genetic predictors of sévère SARS-CoV-2 infection. | At 28 day | 
| Correlation between overall survival at Day 28 and all predictors for Covid-19 | Identify epidemiological, clinical, radiological, biological, immunological, genetic and therapeutic predictors of survival in patients with SARS-CoV-2 infection. | At 28 day | 
| Cumulative incidence of at least one complication related to COVID 19 | Death is a concurrent risk. | during hospitalization or during outpatient follow-up of confirmed case patients at Lille University Hospital (maximum observation period 6 months). | 
| Cumulative incidence of the thrombosis complication related to COVID 19 | Death is a concurrent risk. | during hospitalization or during outpatient follow-up of confirmed case patients at Lille University Hospital (maximum observation period 6 months). | 
| All type of co-infections | Describe viral (other than SARS-CoV-2), bacterial and fungal co-infections in patients admitted for COVID disease 19. The appropriateness of the co-infection search is at the discretion of the clinician to fit the patient's history and clinical presentation | At 6 months | 
| Alteration of microbiota | alterations in respiratory and digestive microbiotes and their evolution potentially associated with bacterial or fungal superinfection in the most severe patients | At 6 months | 
| Biobanking for further analyses such as SARS-CoV2 studies |  | At 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, fatality rate, Inflammatory and autoimmune processes, severity, clinical features, diagnostic (qRT-PCR or serology) methods, thrombosis, co-infection