Clinical trial NCT04341792: Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient
Official title: Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient Admitted to Emergency Departments During an Epidemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection Viral
Coronavirus
COVID-19
Keywords: infection viral
biological risk factor
coronavirus
covid-19
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of secondary aggravation
timeFrame: an average at 30 days (- 2 days +3 days) of admission to the emergency department
Secondary outcomes:
measure: Change of standart biological parameters
timeFrame: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
measure: Change of Von willebrand factor (vWF) changes over time
timeFrame: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
measure: Change of the Factor VIII (FVIII)
timeFrame: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
measure: Prevalence of positivity of COVID-19 virus measured by PCR or serology
timeFrame: an average at 30 days (- 2 days +3 days) of admission to the emergency department
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Delphine Garrigue, MD
role: PRINCIPAL_INVESTIGATOR
References: