Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection

Covid-19 Clinical Trial

— Covid-Thelium  

Official title:

Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04357847
• Other study ID #: 2020/097/OB
• Status: Recruiting
• Start date: April 9, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Rouen
• Contact: emmanuel besnier, MD
• Phone: +33 2 32 88 82 83
• Email: emmanuel.besnier[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Critical Illness
• Critically Ill
• Endothelial Dysfunction
• Thrombosis

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	Association of InterCellular Adhesion Molecule-1 plasma level with 28 days mortality	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.	24 hours
Secondary	Association of Endothelin-1 plasma level with 28 days mortality	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.	24 hours
Secondary	Association of Vascular Endothelial Growth Factor A plasma level with 28 days mortality	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.	24 hours
Secondary	Association of soluble Vascular Endothelial Growth Factor Receptor type 1 with 28 days mortality	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.	24 hours
Secondary	Association of syndecan -1 plasma level with 28 days mortality	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.	24 hours
Secondary	Association of D-dimers plasma levels with thrombotic events	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	24 hours
Secondary	Association of von Willebrandt Factor with thrombotic events	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	24 hours
Secondary	Association of Viscoelastic testing with thrombotic events	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.	24 hours