Covid19ENDOCOVIDNCT04830683
Endothelial Dysfunction in Covid-19
An observational study of Covid19 and Hypoxemic Respiratory Failure, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19, Hypoxemic Respiratory Failure
- How many people
- 85 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Apr 2020to 1 Apr 2021
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Hospitalized patients for SARS-Cov-2 infection
Who may be able to join
- positive result on a reverse-transcriptase-polymerase chain reaction testing performed on nasopharyngeal swab at hospital admission
Who cannot join
- ICU admission more than five days after admission on a general ward,
- concomitant bacterial infection
- older than 75 years
- cirrhosis
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, Belgique, 1040
VIRGINIE MONTIEL, 0032496503912, virginie.montiel@uclouvain.be
About this study
Official title: Endothelial Dysfunction and Oxidative Stress in ICU and Non-ICU Covid-19 Patients With Hypoxemic Respiratory Failure
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.
Read the 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
- Keywords
- Endothelial Dysfunction, Covid19
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ICU or general ward hospital admission
Secondary outcomes (1)
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.
Measured: ICU or general ward hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start27 Apr 2020
- Primary completion25 Mar 2021
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VIRGINIE MONTIEL, MD,PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830683
- Sponsor's protocol ID
- 2020/27AVR/247
- Acronym
- ENDOCOVID
- Status last verified
- Apr 2021
- First submitted
- 26 Mar 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction and Oxidative Stress in ICU and Non-ICU Covid-19 Patients With Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT04830683
- Acronym / sponsor ID
- ENDOCOVID / 2020/27AVR/247
- Conditions
- Covid19, Hypoxemic Respiratory Failure
- Keywords
- Endothelial Dysfunction, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients for SARS-Cov-2 infection
Key inclusion criteria (1 listed)
- positive result on a reverse-transcriptase-polymerase chain reaction testing performed on nasopharyngeal swab at hospital admission
Key exclusion criteria (4 listed)
- ICU admission more than five days after admission on a general ward,
- concomitant bacterial infection
- older than 75 years
- cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vascular oxidative stress in Covid-19 versus septic shock and control patients
Time frame: ICU or general ward hospital admission
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.
1 secondary outcome
Vascular Renin-angiotensin-aldosterone system measurements in Covid-19 versus septic shock and control patients
Time frame: ICU or general ward hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VIRGINIE MONTIEL, MD,PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Hypoxemic Respiratory Failure, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VIRGINIE MONTIEL, MD, PhD (0032496503912, virginie.montiel@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular oxidative stress in Covid-19 versus septic shock and control patients (time frame: ICU or general ward hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.