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

NCT04357847 | Unknown

• 1 other identifier: 2020/097/OB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19; Endothelial Dysfunction; Thrombosis; Critically Ill

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Association of Endothelin-1 plasma level with 28 days mortality

  24 hours

• Association of Vascular Endothelial Growth Factor A plasma level with 28 days mortality

  24 hours

• Association of soluble Vascular Endothelial Growth Factor Receptor type 1 with 28 days mortality

  24 hours

• Association of syndecan -1 plasma level with 28 days mortality

  24 hours

• Association of D-dimers plasma levels with thrombotic events

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients with documented SARS-CoV-2 infection (PCR or CTscan)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 7600, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Thrombosis; Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

emmanuel besnier, MD

CONTACT

+33 2 32 88 82 83; emmanuel.besnier@chu-rouen.fr

thomas clavier, MD, PhD

CONTACT

+33 2 32 88 82 83; thomas.clavier@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 22, 2020
• Study Start: April 9, 2020
• Primary Completion: July 31, 2021
• Study Completion: August 31, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

FR (1)