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Completed

NCT Number: NCT04341792

Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient

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.

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Key information

Conditions

Infection Viral COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, CHU Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: BIOCOVU

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 10, 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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