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

September 23, 2020 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

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Lille, France, 59037
        • Recruiting
        • Hôpital Roger Salengro, CHU Lille
        • Principal Investigator:
          • Delphine Garrigue, MD,PhD

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

No

Genders Eligible for Study

All

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

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 (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_33
  • 2020-A00906-33 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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