Skip to main content
OpenTrials
Completed

NCT Number: NCT04367662

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sampling

Procedure

blood sampling in hospitalized patient for COVID-19 infection

Primary outcomes

  1. Clinical worsening (yes/no) of the patient during hospitalization

    Time frame: in the 15 days from admission

  2. D-DIMERS plasma levels in blood

    Time frame: 1 hour after admission

    Biological analysis using initial blood sampling

  3. Fibrin monomers plasma levels in blood

    Time frame: 1 hour after admission

    Biological analysis using initial blood sampling

  4. Antithrombin plasma levels in blood

    Time frame: 1 hour after admission

    Biological analysis using initial blood sampling

  5. Prothrombin Fragment 1 plasma levels in blood

    Time frame: 1 hour after admission

    Biological analysis using initial blood sampling

  6. Prothrombin Fragment 2 plasma levels in blood

    Time frame: 1 hour after admission

    Biological analysis using initial blood sampling

  7. Thrombin generation test plasma levels in blood

    Time frame: 1 hour after admission

    Biological analysis using initial blood sampling

  8. Microvesicles of platelet plasma levels in blood

    Time frame: 1 hour after admission

    Biological analysis using initial blood sampling

  9. Cross-linked platelets plasma levels in blood

    Time frame: 1 hour after admission

    Biological analysis using initial blood sampling

  10. Willebrand Factor plasma levels in blood

    Time frame: 1 hour after admission

    Biological analysis using initial blood sampling

  11. Factor VIII plasma levels in blood

    Time frame: 1 hour after admission

    Biological analysis using initial blood sampling

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: COVID'HEMOS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.