Clinical trial NCT04367662: Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19
Official title: Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Hemostasis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical worsening (yes/no) of the patient during hospitalization
timeFrame: in the 15 days from admission
measure: D-DIMERS plasma levels in blood
timeFrame: 1 hour after admission
measure: Fibrin monomers plasma levels in blood
timeFrame: 1 hour after admission
measure: Antithrombin plasma levels in blood
timeFrame: 1 hour after admission
measure: Prothrombin Fragment 1 plasma levels in blood
timeFrame: 1 hour after admission
measure: Prothrombin Fragment 2 plasma levels in blood
timeFrame: 1 hour after admission
measure: Thrombin generation test plasma levels in blood
timeFrame: 1 hour after admission
measure: Microvesicles of platelet plasma levels in blood
timeFrame: 1 hour after admission
measure: Cross-linked platelets plasma levels in blood
timeFrame: 1 hour after admission
measure: Willebrand Factor plasma levels in blood
timeFrame: 1 hour after admission
measure: Factor VIII plasma levels in blood
timeFrame: 1 hour after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Paul BILLOIR, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Véronique LE CAM, MD
role: STUDY_DIRECTOR
References: