Covid-19Covid-TheliumNCT04357847
Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection
An observational study of Covid-19 and Endothelial Dysfunction, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Endothelial Dysfunction, Thrombosis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2020to 31 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients with documented SARS-CoV-2 infection (PCR or CTscan)
Who may be able to join
- all adult patients admitted in ICU for covid-19 disease within the past 24 hrs
Who cannot join
- bactrial co-infection at admission
- expected death within the next 24 hrs
- pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Rouen University Hospital
Rouen, 7600
emmanuel besnier, MD, +33 2 32 88 82 83, emmanuel.besnier@chu-rouen.fr
thomas clavier, MD, PhD, +33 2 32 88 82 83, thomas.clavier@chu-rouen.fr
About this study
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
- Medical subject headings
- COVID-19, Thrombosis, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (7)
Association of Endothelin-1 plasma level with 28 days mortality
Endothelin-1 will be assessed in blood as a maker of endothelial injuries, expressed in pg/mL. its association with 28 -days mortality will be evaluated.
Measured: 24 hours
Association of Vascular Endothelial Growth Factor A plasma level with 28 days mortality
Vascular Endothelial Growth Factor A plasma level will be measured in blood as a marker of endothelial injury expressed in pg/mL. its association with 28 -days mortality will be evaluated.
Measured: 24 hours
Association of soluble Vascular Endothelial Growth Factor Receptor type 1 with 28 days mortality
This soluble receptor is another marker of endothelial injury and will be measured in blood and expressed as pg/mL. Its association with 28-days mortality will be evaluated.
Measured: 24 hours
Association of syndecan -1 plasma level with 28 days mortality
syndecan -1 is a marker of degradation of glycocalyx, raised during endothelial injury. It will be measured in blood and expressed as pg/mL. Its assocation with 28-days mortality will be evaluated.
Measured: 24 hours
Association of D-dimers plasma levels with thrombotic events
D-dimers si marker of enhanced thrombotic activity. It may be increased during covid-19 disease but its correlation with endothelial injury is not known. It will be measured in blood and expressed as microgrammes/L, and then correlated with ICAM-1 plasma levels
Measured: 24 hours
Association of von Willebrandt Factor with thrombotic events
This marker may be raised during endothelial injury and may explained thrombotic status of covid-19 patients. Its blood levels will be measured and expressed as international unit/dL, and correlated with ICAM-1 plasma levels
Measured: 24 hours
Association of Viscoelastic testing with thrombotic events
Clot Stiffness and its fibrinogen and platelet contributions (expressed in kPa) will be measured as novative approach, using Quantra (Stago Inc) device, to explore hemostasis alterations of covid-19 patients.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start9 Apr 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EBESNIER, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357847
- Sponsor's protocol ID
- 2020/097/OB
- Acronym
- Covid-Thelium
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04357847
- Acronym / sponsor ID
- Covid-Thelium / 2020/097/OB
- Conditions
- Covid-19, Endothelial Dysfunction, Thrombosis, Critically Ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 22 Apr 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients with documented SARS-CoV-2 infection (PCR or CTscan)
Key inclusion criteria (1 listed)
- all adult patients admitted in ICU for covid-19 disease within the past 24 hrs
Key exclusion criteria (3 listed)
- bactrial co-infection at admission
- expected death within the next 24 hrs
- pregnancy
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
Association of InterCellular Adhesion Molecule-1 plasma level with 28 days mortality
Time frame: 24 hours
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.
7 secondary outcomes
Association of Endothelin-1 plasma level with 28 days mortality
Time frame: 24 hours
Association of Vascular Endothelial Growth Factor A plasma level with 28 days mortality
Time frame: 24 hours
Association of soluble Vascular Endothelial Growth Factor Receptor type 1 with 28 days mortality
Time frame: 24 hours
Association of syndecan -1 plasma level with 28 days mortality
Time frame: 24 hours
Association of D-dimers plasma levels with thrombotic events
Time frame: 24 hours
Association of von Willebrandt Factor with thrombotic events
Time frame: 24 hours
Association of Viscoelastic testing with thrombotic events
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Covid-19 and Endothelial Dysfunction, run by University Hospital, Rouen at 1 site in France.
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 3 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 28 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 France. 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 emmanuel besnier, MD (+33 2 32 88 82 83, emmanuel.besnier@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of InterCellular Adhesion Molecule-1 plasma level with 28 days mortality (time frame: 24 hours). 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 28 Apr 2021.