Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient

COVID-19 Clinical Trial

— BIOCOVU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04341792
• Other study ID #: 2020_33
• Secondary ID: 2020-A00906-33
• Status: Recruiting
• Start date: April 11, 2020
• Est. completion date: April 2021

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: Delphine Garrigue, MD
• Phone: 03 20 44 67 97
• Email: Delphine.garrigue[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID-19
• Infection Viral
• Virus Diseases

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of standart biological parameters	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
Secondary	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
Secondary	Change of the Factor VIII (FVIII)		Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
Secondary	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