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Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19 (COVID'HEMOS)

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sampling
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19 focused on measuring Hemostasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with COVID-19 infection

Arm Description

Patient with COVID-19 infection hospitalized in a COVID unit

Outcomes

Primary Outcome Measures

Clinical worsening (yes/no) of the patient during hospitalization
D-DIMERS plasma levels in blood
Biological analysis using initial blood sampling
Fibrin monomers plasma levels in blood
Biological analysis using initial blood sampling
Antithrombin plasma levels in blood
Biological analysis using initial blood sampling
Prothrombin Fragment 1 plasma levels in blood
Biological analysis using initial blood sampling
Prothrombin Fragment 2 plasma levels in blood
Biological analysis using initial blood sampling
Thrombin generation test plasma levels in blood
Biological analysis using initial blood sampling
Microvesicles of platelet plasma levels in blood
Biological analysis using initial blood sampling
Cross-linked platelets plasma levels in blood
Biological analysis using initial blood sampling
Willebrand Factor plasma levels in blood
Biological analysis using initial blood sampling
Factor VIII plasma levels in blood
Biological analysis using initial blood sampling

Secondary Outcome Measures

Full Information

First Posted
April 16, 2020
Last Updated
June 5, 2020
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT04367662
Brief Title
Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19
Acronym
COVID'HEMOS
Official Title
Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 9, 2020 (Actual)
Primary Completion Date
May 14, 2020 (Actual)
Study Completion Date
May 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Hemostasis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with COVID-19 infection
Arm Type
Experimental
Arm Description
Patient with COVID-19 infection hospitalized in a COVID unit
Intervention Type
Procedure
Intervention Name(s)
blood sampling
Intervention Description
blood sampling in hospitalized patient for COVID-19 infection
Primary Outcome Measure Information:
Title
Clinical worsening (yes/no) of the patient during hospitalization
Time Frame
in the 15 days from admission
Title
D-DIMERS plasma levels in blood
Description
Biological analysis using initial blood sampling
Time Frame
1 hour after admission
Title
Fibrin monomers plasma levels in blood
Description
Biological analysis using initial blood sampling
Time Frame
1 hour after admission
Title
Antithrombin plasma levels in blood
Description
Biological analysis using initial blood sampling
Time Frame
1 hour after admission
Title
Prothrombin Fragment 1 plasma levels in blood
Description
Biological analysis using initial blood sampling
Time Frame
1 hour after admission
Title
Prothrombin Fragment 2 plasma levels in blood
Description
Biological analysis using initial blood sampling
Time Frame
1 hour after admission
Title
Thrombin generation test plasma levels in blood
Description
Biological analysis using initial blood sampling
Time Frame
1 hour after admission
Title
Microvesicles of platelet plasma levels in blood
Description
Biological analysis using initial blood sampling
Time Frame
1 hour after admission
Title
Cross-linked platelets plasma levels in blood
Description
Biological analysis using initial blood sampling
Time Frame
1 hour after admission
Title
Willebrand Factor plasma levels in blood
Description
Biological analysis using initial blood sampling
Time Frame
1 hour after admission
Title
Factor VIII plasma levels in blood
Description
Biological analysis using initial blood sampling
Time Frame
1 hour after admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul BILLOIR, pharmacist
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Véronique LE CAM, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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