Endothelial Dysfunction in Covid-19

NCT04830683 | Unknown

• 1 other identifier: 2020/27AVR/247
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Hypoxemic Respiratory Failure

Keywords

Endothelial Dysfunction; Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Vascular Renin-angiotensin-aldosterone system measurements in Covid-19 versus septic shock and control patients

  ICU or general ward hospital admission

Study Arms (4)

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

non-ICU Covid-19 patients

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

matched control subjects

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized patients for SARS-Cov-2 infection

You may qualify if:

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

You may not qualify if:

• ICU admission more than five days after admission on a general ward,
• concomitant bacterial infection
• older than 75 years
• cirrhosis

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, Belgique, 1040, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma samples.

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

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; Respiration Disorders

Study Officials

• VIRGINIE MONTIEL, MD,PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VIRGINIE MONTIEL, MD, PhD

CONTACT

0032496503912; virginie.montiel@uclouvain.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 5, 2021
• Study Start: April 27, 2020
• Primary Completion: March 25, 2021
• Study Completion: April 1, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)