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

• Conditions: Covid-19; Endothelial Dysfunction; Thrombosis; Critically Ill

• Registration Number: NCT04357847
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-09
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-22
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-07-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association of InterCellular Adhesion Molecule-1 plasma level with 28 days mortality	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

Name	Time	Method
Association of soluble Vascular Endothelial Growth Factor Receptor type 1 with 28 days mortality	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.
Association of syndecan -1 plasma level with 28 days mortality	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.
Association of Vascular Endothelial Growth Factor A plasma level with 28 days mortality	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.
Association of von Willebrandt Factor with thrombotic events	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
Association of Viscoelastic testing with thrombotic events	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.
Association of D-dimers plasma levels with thrombotic events	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
Association of Endothelin-1 plasma level with 28 days mortality	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.

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France