Endothelial Dysfunction in Covid-19

NCT ID: NCT04830683

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-27
• Study Completion Date: 2021-04-01

Brief 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.

Detailed 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.

Conditions

Covid19; Hypoxemic Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ICU Covid-19 patients

Covid-19 patients admitted for refractory respiratory failure despite conventional oxygen therapy requiring Intensive Care Unit (ICU) admission and oxygenation through either High Flow Nasal Cannula (HFNC) therapy or endotracheal intubation with mechanical ventilation

No interventions assigned to this group

non-ICU Covid-19 patients

Covid-19 patients admitted at hospital requiring conventional oxygen or continuous positive airways pressure (cpap)

No interventions assigned to this group

matched control subjects

Healthy subjects matched for similar cardiovascular risk factors than ICU Covid-19 patients

No interventions assigned to this group

ICU septic shock patients

Septic shock patients corresponded to refractory hypotension in response to an infection, in non Covid-19 patients, requiring ICU hospitalisation for vasopressors to maintain mean arterial pressure (MAP) \> 65mm Hg despite adequate volume resuscitation according to the Surviving Sepsis Campaign

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

VIRGINIE MONTIEL, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Cliniques Universitaires Saint Luc

Brussels, Belgique, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

VIRGINIE MONTIEL, MD, PhD

Role: CONTACT

virginie.montiel@uclouvain.be

0032496503912

Facility Contacts

VIRGINIE MONTIEL

Role: primary

virginie.montiel@uclouvain.be

0032496503912

Other Identifiers

2020/27AVR/247

Identifier Type: -

Identifier Source: org_study_id