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

COVID-19 Clinical Trial

— COVID'HEMOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367662
• Other study ID #: 2020/0104/OB
• Status: Completed
• Phase: N/A
• Start date: April 9, 2020
• Est. completion date: May 14, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 14, 2020
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Severe Acute Respiratory Syndrome
• Thrombophilia

Intervention

Procedure:
• blood sampling
blood sampling in hospitalized patient for COVID-19 infection

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

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