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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04475211
Other study ID # 2020_54
Secondary ID 2020-A01514-35
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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