Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient (BIOCOVU)

December 17, 2025 updated by: University Hospital, Lille

Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient Admitted to Emergency Departments During an Epidemic

There is no predictive tool for patients admitted to the emergency department with a suspicion of Covid-19 that will worsen secondarily and require a heavy lifting.

In a context of saturation of the healthcare system by the pandemic at Covid-19,it is essential to identify specific, accessible prognostic markers via minimally invasive sampling with low risk of infection for personnel caregiver, for optimal allocation of resuscitation resources.

This study proposes to evaluate the biological markers of routine care known to be associated with resuscitation admission in relation to hospitalization on conventional service for the prediction of worsening of patients admitted to the emergencies for Covid-19.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

373

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Lille, France, 59037
    - Hôpital Roger Salengro, CHU Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Adult population presenting to the emergency department during this pandemic period with symptoms suggestive of Covid-19 infection with no other probable diagnosis.

Description

Inclusion Criteria:

Clinical criteria for suspicion of Covid-19 in an epidemic period
Consultation in the emergency departement
Non-opposition agree

Exclusion Criteria:

impairment related to another identified cause than Covid-19, in particular a rapid diagnostic test flu-positive
Severe patient from the outset with transfer to intensive care within 12 hours of admission to the Emergency Department
No social security coverage (beneficiary or entitled person)
Poor understanding of French
Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of secondary aggravation Time Frame: an average at 30 days (- 2 days +3 days) of admission to the emergency department	Secondary aggravation is defined as : a re-hospitalization or aggravation in hospitalization : development or increase in oxygen dependency, hemodynamic failure, and/or respiratory, death	an average at 30 days (- 2 days +3 days) of admission to the emergency department

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of standart biological parameters Time Frame: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department	the number of leukocytes, lymphocytes, neutrophil polynuclear cells, CRP, fibrinogen, and the D-dimers.	Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
Change of Von willebrand factor (vWF) changes over time Time Frame: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department		Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
Change of the Factor VIII (FVIII) Time Frame: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department		Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
Prevalence of positivity of COVID-19 virus measured by PCR or serology Time Frame: an average at 30 days (- 2 days +3 days) of admission to the emergency department		an average at 30 days (- 2 days +3 days) of admission to the emergency department

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

Principal Investigator: Delphine Garrigue, MD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ledoult E, Guerrier T, Dubucquoi S, Figeac M, Villenet C, Daunou B, Behal H, Pokeerbux MR, Machet T, Koether V, Collet A, Launay D; Lille Covid Research network (LICORNE). Dual role of plasmablasts as immune regulators or amplifiers in COVID-19. Clin Immunol. 2025 Oct 13;281:110609. doi: 10.1016/j.clim.2025.110609. Online ahead of print.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2020

Primary Completion (Actual)

November 12, 2020

Study Completion (Actual)

November 12, 2020

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria