Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19

NCT04367662 | Completed

• 1 other identifier: 2020/0104/OB
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Hemostasis

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

Patient with COVID-19 infection

EXPERIMENTAL

Patient with COVID-19 infection hospitalized in a COVID unit

Procedure: blood sampling

Interventions

blood sampling PROCEDURE

blood sampling in hospitalized patient for COVID-19 infection

Patient with COVID-19 infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient under protective guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paul BILLOIR, pharmacist

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

• Véronique LE CAM, MD

  University Hospital, Rouen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 29, 2020
• Study Start: April 9, 2020
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)