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

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ClinicalTrials.gov Identifier: NCT04341792
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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
Infection Viral Coronavirus COVID-19

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Study Type : Observational
Estimated 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 : April 11, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341792


Contacts
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Contact: Delphine Garrigue, MD 03 20 44 67 97 ext +33 Delphine.garrigue@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, CHU Lille Recruiting
Lille, France, 59037
Contact    0320445962      
Principal Investigator: Delphine Garrigue, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Delphine Garrigue, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04341792    
Other Study ID Numbers: 2020_33
2020-A00906-33 ( Other Identifier: ID-RCB number,ANSM )
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
infection viral
biological risk factor
coronavirus
covid-19
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Virus Diseases
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases