NCT04475211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
757

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

July 10, 2020

Last Update Submit

December 17, 2025

Conditions

Keywords

COVID-19fatality rateInflammatory and autoimmune processesseverityclinical featuresdiagnostic (qRT-PCR or serology) methodsthrombosisco-infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

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

    At inclusion (day 0)

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

    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

    At inclusion (day 0)

  • Correlation between hospitalisation and all predictors for Covid-19

    At inclusion( Day 0)

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

    At 28 day

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All adult "suspect patient", "possible case", "probable case" or "confirmed case" of an SARS-CoV-2 infection admitted to Lille University Hospital.

You may not qualify if:

  • 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.
  • Translated with www.DeepL.com/Translator (free version)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Claude Huriez Chr Lille

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, plasma, serum

MeSH Terms

Conditions

COVID-19DiseaseThrombosisCoinfection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Marie-Charlotte CHOPIN, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 17, 2020

Study Start

August 10, 2020

Primary Completion

June 15, 2022

Study Completion

June 15, 2022

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations