Endothelial Dysfunction in Covid-19

Covid19 Clinical Trial

— ENDOCOVID  

Official title:

Endothelial Dysfunction and Oxidative Stress in ICU and Non-ICU Covid-19 Patients With Hypoxemic Respiratory Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830683
• Other study ID #: 2020/27AVR/247
• Status: Recruiting
• Start date: April 27, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: VIRGINIE MONTIEL, MD, PhD
• Phone: 0032496503912
• Email: virginie.montiel[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

SARS-CoV-2 targets endothelial cells via the angiotensin-converting enzyme 2 receptor. The specific impact of the resulting endothelial injury is currently unknown but may contribute to the pro-coagulant state classically described during Covid-19 disease and commonly associated with an exacerbated activation of the renin-angiotensin-aldosterone system.

Description:

We prospectively compared clinical and biological parameters in ICU- and non-ICU-admitted Covid-19 patients, ICU-admitted patients with septic shock unrelated to Covid-19 and matched control subjects.

Primary hemostasis and coagulation parameters and endothelial biomarkers are measured. Activation of the renin-angiotensin-aldosterone system is monitored through measurements of plasma renin, angiotensin II, aldosterone, and serum soluble angiotensin-converting enzyme 2. Vascular oxidative status is assessed by measuring plasma lipids peroxides. Neutrophilic polymorphonuclear activation is assessed by measuring plasma levels of Triggering receptor expressed on myeloid cells-1. Vascular nitric oxide bioavailability is measured by quantification of the concentration of heme-nitrosylated hemoglobin (HbNO) in venous erythrocytes using Electron Paramagnetic Resonance spectroscopy. Structural abnormalities of vascular endothelial cells were analyzed by Transmission Electron- and Scanning Electron Microscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: April 1, 2021
• Est. primary completion date: March 25, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• positive result on a reverse-transcriptase-polymerase chain reaction testing performed on nasopharyngeal swab at hospital admission

Exclusion Criteria:

• ICU admission more than five days after admission on a general ward,

• concomitant bacterial infection

• older than 75 years

• cirrhosis

Related Conditions & MeSH terms

• Covid19
• Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels	Belgique

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular oxidative stress in Covid-19 versus septic shock and control patients	HbNO (nmol/L) and NOX levels (µM/L), oxidative stress with plasma lipids peroxides (mmol/L) levels and soluble TREM-1 measurements. Blood HbNO levels directly correlate with endothelial function and inversely with major cardiovascular risk factors. The nitrite/nitrate levels (NOx) are the the stable end products of NO metabolism that also suggest NO production. Plasma lipids peroxides reflets the surrounding endovascular oxidative stress. sTREM-1 participates in the sepsis-induced ROS production through activation of NADPH oxidase (NOX)-2 during the respiratory burst of activated polymorphonuclear.	ICU or general ward hospital admission
Secondary	Vascular Renin-angiotensin-aldosterone system measurements in Covid-19 versus septic shock and control patients	Renin (pg/mL), Agiotensin II (fmol/mL), Aldosterone (pg/mL) measurements. The RAAS system is a classical activator of vascular NOX2 and ROS production.	ICU or general ward hospital admission