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

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Procedure: blood sampling

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Rouen university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patient with COVID-19 infection; Patient with COVID-19 infection hospitalized in a COVID unit	Procedure: blood sampling; blood sampling in hospitalized patient for COVID-19 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical worsening (yes/no) of the patient during hospitalization		in the 15 days from admission
D-DIMERS plasma levels in blood	Biological analysis using initial blood sampling	1 hour after admission
Fibrin monomers plasma levels in blood	Biological analysis using initial blood sampling	1 hour after admission
Antithrombin plasma levels in blood	Biological analysis using initial blood sampling	1 hour after admission
Prothrombin Fragment 1 plasma levels in blood	Biological analysis using initial blood sampling	1 hour after admission
Prothrombin Fragment 2 plasma levels in blood	Biological analysis using initial blood sampling	1 hour after admission
Thrombin generation test plasma levels in blood	Biological analysis using initial blood sampling	1 hour after admission
Microvesicles of platelet plasma levels in blood	Biological analysis using initial blood sampling	1 hour after admission
Cross-linked platelets plasma levels in blood	Biological analysis using initial blood sampling	1 hour after admission
Willebrand Factor plasma levels in blood	Biological analysis using initial blood sampling	1 hour after admission
Factor VIII plasma levels in blood	Biological analysis using initial blood sampling	1 hour after admission

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• 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): April 9, 2020
• Primary Completion (ACTUAL): May 14, 2020
• Study Completion (ACTUAL): May 14, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (ACTUAL): April 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Hemostasis
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Hematologic Diseases; COVID-19; Coronavirus Infections; Thrombophilia
• Other Study ID Numbers: 2020/0104/OB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No