LILLE COVID RESEARCH NETWORK (Covid-19) (LICORNE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Sars-CoV2

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Marie-Charlotte CHOPIN, MD; Phone Number: +33 0320445743; Email: mariecharlotte.chopin@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hop Claude Huriez Chr Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

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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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Marie-Charlotte CHOPIN, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; clinical features; thrombosis; severity; co-infection; fatality rate; Inflammatory and autoimmune processes; diagnostic (qRT-PCR or serology) methods
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020_54; 2020-A01514-35 (Other Identifier: ID-RCB number,ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No