LILLE COVID RESEARCH NETWORK (Covid-19)

Sars-CoV2 Clinical Trial

— LICORNE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04475211
• Other study ID #: 2020_54
• Secondary ID: 2020-A01514-35
• Status: Recruiting
• Start date: August 10, 2020
• Est. completion date: August 2022

Study information

• Verified date: November 2020
• Source: University Hospital, Lille
• Contact: Marie-Charlotte CHOPIN, MD
• Phone: 0320445743
• Email: mariecharlotte.chopin[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sars-CoV2

Locations

Country	Name	City	State
France	Hop Claude Huriez Chr Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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).
Secondary	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).
Secondary	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
Secondary	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
Secondary	Biobanking for further analyses such as SARS-CoV2 studies		At 6 months