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Completed

NCT Number: NCT04475211

LILLE COVID RESEARCH NETWORK (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.

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Key information

Conditions

Sars-CoV2 COVID-19 Cardiovascular Diseases Coinfection Coronaviridae Infections Coronavirus Infections Disease Embolism and Thrombosis Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thrombosis Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Claude Huriez Chr Lille

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of patients "confirmed cases" of SARS-CoV-2 infection who died at D28 of inclusion

    Time frame: At 28 days

    Identify predictors of mortality at day 28 in patients treated at the Lille University Hospital for COVID-19

Secondary outcomes

  1. Correlation between Infection characteristics of patients at inclusion and all predictors for Covid-19

    Time frame: At inclusion (day 0)

    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.

  2. Correlation between evolution infection characteristics of patients during stay of hospitalisation and all predictors for Covid-19

    Time frame: 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

    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.

  3. Positivity for Covid-19 patients performed and all predictors for Covid-19

    Time frame: At inclusion (day 0)

    The diagnosis of disease is excluded or confirmed by qRT-PCR SARS-CoV-2 (respiratory samples, blood, stool...) and/or serology.

  4. Correlation between hospitalisation and all predictors for Covid-19

    Time frame: At inclusion( Day 0)

    Identify epidemiological, clinical, radiological, biological, immunological and genetic predictors of hospitalization in patients with SARS-CoV-2 infection.

  5. Correlation between risk factors measured at D0 for severe CoV-2 SARS infection and all predictors for Covid-19

    Time frame: At 28 day

    Identify epidemiological, clinical, radiological, biological, immunological and genetic predictors of sévère SARS-CoV-2 infection.

  6. Correlation between overall survival at Day 28 and all predictors for Covid-19

    Time frame: At 28 day

    Identify epidemiological, clinical, radiological, biological, immunological, genetic and therapeutic predictors of survival in patients with SARS-CoV-2 infection.

  7. Cumulative incidence of at least one complication related to COVID 19

    Time frame: during hospitalization or during outpatient follow-up of "confirmed case" patients at Lille University Hospital (maximum observation period 6 months).

    Death is a concurrent risk.

  8. Cumulative incidence of the thrombosis complication related to COVID 19

    Time frame: during hospitalization or during outpatient follow-up of "confirmed case" patients at Lille University Hospital (maximum observation period 6 months).

    Death is a concurrent risk.

  9. All type of co-infections

    Time frame: At 6 months

    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

  10. Alteration of microbiota

    Time frame: At 6 months

    alterations in respiratory and digestive microbiotes and their evolution potentially associated with bacterial or fungal superinfection in the most severe patients

  11. Biobanking for further analyses such as SARS-CoV2 studies

    Time frame: At 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: LICORNE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 17, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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