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Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection (Covid-Thelium)

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ClinicalTrials.gov Identifier: NCT04357847
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
EBESNIER, University Hospital, Rouen

Brief Summary:
The outbreak at covid-19 is caused by the SARS-CoV-2 virus. This virus can be responsible for severe respiratory failure but also for extra-respiratory organ dysfunctions associated with severe inflammatory stress. The endothelium is an important structure of the blood vessels and is implicated in the organ failure of many patients admitted in intensive care units. It could be affected by the virus and its alteration may explain the organ dysfunction of covid-19 ICU patients as well as the thrombotic processes frequently obstructed in this infection.

Condition or disease
Covid-19 Endothelial Dysfunction Thrombosis Critically Ill

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection
Actual Study Start Date : April 9, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : August 31, 2021



Primary Outcome Measures :
  1. Association of InterCellular Adhesion Molecule-1 plasma level with 28 days mortality [ Time Frame: 24 hours ]
    Plasma of covid-19 patients will be tested for endothelial injuries, notably with the measurement of InterCellular Adhesion Molecule 1 level by Enzym-Linked Immunosorbent Assay. The association of these levels with 28-days mortality will be evaluated as prognosis markers.


Secondary Outcome Measures :
  1. Association of Endothelin-1 plasma level with 28 days mortality [ Time Frame: 24 hours ]
    Endothelin-1 will be assessed in blood as a maker of endothelial injuries, expressed in pg/mL. its association with 28 -days mortality will be evaluated.

  2. Association of Vascular Endothelial Growth Factor A plasma level with 28 days mortality [ Time Frame: 24 hours ]
    Vascular Endothelial Growth Factor A plasma level will be measured in blood as a marker of endothelial injury expressed in pg/mL. its association with 28 -days mortality will be evaluated.

  3. Association of soluble Vascular Endothelial Growth Factor Receptor type 1 with 28 days mortality [ Time Frame: 24 hours ]
    This soluble receptor is another marker of endothelial injury and will be measured in blood and expressed as pg/mL. Its association with 28-days mortality will be evaluated.

  4. Association of syndecan -1 plasma level with 28 days mortality [ Time Frame: 24 hours ]
    syndecan -1 is a marker of degradation of glycocalyx, raised during endothelial injury. It will be measured in blood and expressed as pg/mL. Its assocation with 28-days mortality will be evaluated.

  5. Association of D-dimers plasma levels with thrombotic events [ Time Frame: 24 hours ]
    D-dimers si marker of enhanced thrombotic activity. It may be increased during covid-19 disease but its correlation with endothelial injury is not known. It will be measured in blood and expressed as microgrammes/L, and then correlated with ICAM-1 plasma levels

  6. Association of von Willebrandt Factor with thrombotic events [ Time Frame: 24 hours ]
    This marker may be raised during endothelial injury and may explained thrombotic status of covid-19 patients. Its blood levels will be measured and expressed as international unit/dL, and correlated with ICAM-1 plasma levels

  7. Association of Viscoelastic testing with thrombotic events [ Time Frame: 24 hours ]
    Clot Stiffness and its fibrinogen and platelet contributions (expressed in kPa) will be measured as novative approach, using Quantra (Stago Inc) device, to explore hemostasis alterations of covid-19 patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients with documented SARS-CoV-2 infection (PCR or CTscan)
Criteria

Inclusion Criteria:

  • all adult patients admitted in ICU for covid-19 disease within the past 24 hrs

Exclusion Criteria:

  • bactrial co-infection at admission
  • expected death within the next 24 hrs
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357847


Contacts
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Contact: emmanuel besnier, MD +33 2 32 88 82 83 emmanuel.besnier@chu-rouen.fr
Contact: thomas clavier, MD, PhD +33 2 32 88 82 83 thomas.clavier@chu-rouen.fr

Locations
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France
Rouen University Hospital Recruiting
Rouen, France, 7600
Contact: emmanuel besnier, MD    +33 2 32 88 82 83    emmanuel.besnier@chu-rouen.fr   
Contact: thomas clavier, MD, PhD    +33 2 32 88 82 83    thomas.clavier@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Rouen
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Responsible Party: EBESNIER, Principal investigator, University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT04357847    
Other Study ID Numbers: 2020/097/OB
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Critical Illness
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes