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

NCT ID: NCT04367662

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-09
• Study Completion Date: 2020-05-14

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with COVID-19 infection

Patient with COVID-19 infection hospitalized in a COVID unit

Group Type: EXPERIMENTAL

blood sampling

Intervention Type: PROCEDURE

blood sampling in hospitalized patient for COVID-19 infection

Interventions

blood sampling

blood sampling in hospitalized patient for COVID-19 infection

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul BILLOIR, pharmacist

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Véronique LE CAM, MD

Role: STUDY_DIRECTOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2020/0104/OB

Identifier Type: -

Identifier Source: org_study_id