Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient

NCT04341792 | Completed

• 2 other identifiers: 2020_332020-A00906-33
• Study Type: observational
• Target: 373
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection Viral; Coronavirus; COVID-19

Keywords

infection viral; biological risk factor; coronavirus; covid-19

Outcome Measures

Primary Outcomes (1)

• Rate of secondary aggravation

  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 Outcomes (4)

• Change of standart biological parameters

  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

  Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department

• Change of the Factor VIII (FVIII)

  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

  an average at 30 days (- 2 days +3 days) of admission to the emergency department

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHU Lille

Lille, 59037, France

Location

Related Publications (1)

• 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.

  PMID: 41093046 DERIVED

MeSH Terms

Conditions

Virus Diseases; Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Delphine Garrigue, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: April 11, 2020
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)