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

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04341792

Collaborator

(none)

1,000

Enrollment

Location

11.7

Anticipated Duration (Months)

85.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection Viral Coronavirus COVID-19

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 11, 2020

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Outcome Measures

Primary Outcome Measures

Rate of secondary aggravation [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 Outcome Measures

Change of standart biological parameters [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.
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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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