Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19 (COVID'HEMOS)
Coronavirus COVID-19 is an emerging virus also called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Eighty percent of patients are poor or asymptomatic. However, there are major respiratory complications for some patients, requiring intensive care hospitalization and possibly leading to death in 5% of cases. One of the hypotheses put forward is that much of the pathophysiology is due to endothelial dysfunction associated with disseminated intravascular coagulation.
The covid-19 pathology could induce coagulation impairment as observed during sepsis. An increase in D-dimer levels during covid-19 disease is itself associated with excess mortality. While D-dimers are highly sensitive, they are not specific for clotting activity. They may be increased in many other circumstances, particularly in inflammation.
On the other hand, the infection stimulates the release of extracellular vesicles. These vesicles, of multiple cellular origin, are an actor of vascular homeostasis, and participate in the state of hyperactivation of coagulation. They have a major role in the prothrombotic state and the development of coagulopathy associated with sepsis.
The aim of our monocentric prospective study would be to study early and more specific markers of hypercoagulability and markers of routine endothelial dysfunction, as soon as the patient is hospitalized, in order to predict the risk of hospitalization in intensive care.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Rouen, France
- Rouen University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any adult patient admitted to Rouen University Hospital for documented SARS-Cov-2 infection (PCR Test or CT scan)
- Patient who accept to participate to research after reading the information note
- Patient affiliated with Social Security
Exclusion Criteria:
- Patient under protective guardianship or curatorship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Patient with COVID-19 infection
Patient with COVID-19 infection hospitalized in a COVID unit
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blood sampling in hospitalized patient for COVID-19 infection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical worsening (yes/no) of the patient during hospitalization
Time Frame: in the 15 days from admission
|
in the 15 days from admission
|
|
|
D-DIMERS plasma levels in blood
Time Frame: 1 hour after admission
|
Biological analysis using initial blood sampling
|
1 hour after admission
|
|
Fibrin monomers plasma levels in blood
Time Frame: 1 hour after admission
|
Biological analysis using initial blood sampling
|
1 hour after admission
|
|
Antithrombin plasma levels in blood
Time Frame: 1 hour after admission
|
Biological analysis using initial blood sampling
|
1 hour after admission
|
|
Prothrombin Fragment 1 plasma levels in blood
Time Frame: 1 hour after admission
|
Biological analysis using initial blood sampling
|
1 hour after admission
|
|
Prothrombin Fragment 2 plasma levels in blood
Time Frame: 1 hour after admission
|
Biological analysis using initial blood sampling
|
1 hour after admission
|
|
Thrombin generation test plasma levels in blood
Time Frame: 1 hour after admission
|
Biological analysis using initial blood sampling
|
1 hour after admission
|
|
Microvesicles of platelet plasma levels in blood
Time Frame: 1 hour after admission
|
Biological analysis using initial blood sampling
|
1 hour after admission
|
|
Cross-linked platelets plasma levels in blood
Time Frame: 1 hour after admission
|
Biological analysis using initial blood sampling
|
1 hour after admission
|
|
Willebrand Factor plasma levels in blood
Time Frame: 1 hour after admission
|
Biological analysis using initial blood sampling
|
1 hour after admission
|
|
Factor VIII plasma levels in blood
Time Frame: 1 hour after admission
|
Biological analysis using initial blood sampling
|
1 hour after admission
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul BILLOIR, pharmacist, Rouen University Hospital
- Study Director: Véronique LE CAM, MD, Rouen University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/0104/OB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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