ARDS, HumanVASCOVNCT05074758
Characterization of the microVAScular Dysfunction in Covid-19 ARDS
An observational study of ARDS, Human and COVID-19 Acute Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary endpoint of this research is to establish that the alveolar dead space is significantly higher in patients with COVID-19 ARDS, compared to patients with non-COVID-19 ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- alveolar dead-space quantification, Coagulation activation and impaired fibrinolysis explorations and Endothelial activation / endothelial senescence
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2021to 6 Mar 2023
- 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: Patients with moderate or severe ARDS linked or not with covid-19
Who may be able to join
- Age> 18 years old
- Invasive mechanical ventilation in place for less than 48 hours
- Severe or moderate ARDS (defined according to the Berlin classification)
- Virological confirmation by PCR of SARS-CoV-2 infection (ARDS COVID-19)
- Lack of virological confirmation by PCR of SARS-CoV-2 infection (ARDS not linked to COVID-19)
- Patient information
Who cannot join
- Massive pulmonary embolism
- Chronic respiratory failure under long-term oxygen therapy
- Dying patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of the microVAScular Dysfunction in COvid-19 ARDS
The primary endpoint of this research is to establish that the alveolar dead space is significantly higher in patients with COVID-19 ARDS, compared to patients with non-COVID-19 ARDS.
Secondarily, the investigators want to establish the prognostic value of the alveolar-dead space (measured iteratively) in patients with COVID-19 and non-COVID-19 ARDS, to establish the respective influences of the biological parameters of endothelial damage, of the biological parameters of coagulopathy, of the parameters set on the artificial ventilator on the value of the alveolar dead space; in ARDS patients with COVID-19 and non-COVID-19 ARDS, to establish the prognostic value of the laboratory parameters of endothelial damage and coagulopathy in patients with COVID-19 and non-COVID-19 ARDS.
Read the detailed description
Endothelial damage and coagulation activation at the lung microvascular level may play an important role in the physiopathology of the COVID-19 ARDS. The project aims to prospectively investigate both bedside pulmonary physiological markers and biological markers of coagulopathy and endothelial dysfunction in COVID-19 and non-COVID-19 ARDS patients.
- Being tested
- alveolar dead-space quantification, Coagulation activation and impaired fibrinolysis explorations, Endothelial activation / endothelial senescence
- Keywords
- pulmonary biological markers, alveolar dead-space, circulating endothelial cells
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar dead-space quantificationDiagnostic test
measurement of alveolar dead-space based on volumetric capnography
Coagulation activation and impaired fibrinolysis explorationsDiagnostic test
blood sampling:
- Fibrinolytic components
- NETs components
- Elastase-derived fragments of proteins of interest
Endothelial activation / endothelial senescenceDiagnostic test
circulating endothelial cells, E-selectin, endoglin, LVEF-A, LVEFR-2, Angiopoietin -1 and -2, cKit and SDF-1 Willebrand factor (activity, antigen, multimeric analysis )
| Study group | Role | What they receive |
|---|---|---|
| non-COVID-19 ARDS patients | 20 patients with acute respiratory distress syndrome (ARDS) unrelated to COVID-19 Receives: Diagnostic Test: alveolar dead-space quantification; Diagnostic Test: Coagulation activation and impaired fibrinolysis explorations; Diagnostic Test: Endothelial activation / endothelial senescence | |
| COVID-19 ARDS patients | 20 patients with acute respiratory distress syndrome (ARDS) linked to COVID-19 Receives: Diagnostic Test: alveolar dead-space quantification; Diagnostic Test: Coagulation activation and impaired fibrinolysis explorations; Diagnostic Test: Endothelial activation / endothelial senescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of alveolar dead space
Recording the exhaled CO2 curve (side-stream capnography method) and volume curve, as determined by the mechanical ventilator, and computing the signals with the arterial CO2 partial pressure, reflecting the partial pressure of CO2 in the alveoli participating in gas exchanges), determined on arterial blood gas (ABG) sampling.
Measured: Up to 28 days
Secondary outcomes (12)
Prognostic value of the alveolar dead space (measured iteratively)
To establish the link between alveolar dead-space values and Day 20 mortality
Measured: 20 days
Prognostic value of the alveolar dead space (measured iteratively)
To establish the link between alveolar dead-space values and Day 20 mortality and Day-28 invasive ventilator-free days.
Measured: 28 days
Level of circulating endothelial cells
To describe the biological parameters of endothelial damage and prognostic value
Measured: Up to 28 days
Level of progenitor cells
To describe the biological parameters of endothelial damage and prognostic value
Measured: Up to 28 days
Level of circulating stem cells
To describe the biological parameters of endothelial damage and prognostic value
Measured: Up to 28 days
Level of endothelial proteomics
To describe the biological parameters of endothelial damage and prognostic value
Measured: Up to 28 days
Level of D-dimers
To describe the biological parameters of endothelial damage and prognostic value
Measured: Up to 28 days
Level of Willebrand Factor
To describe the biological parameters of endothelial damage and prognostic value
Measured: Up to 28 days
Level of components of the fibrinolytic system
To describe the biological parameters of endothelial damage and prognostic value
Measured: Up to 28 days
Level of fragments of plasminogen
To describe the biological parameters of endothelial damage and prognostic value
Measured: Up to 28 days
Level of the components of the NETs (Neutrophil Extracellular Traps)
To describe the biological parameters of endothelial damage and prognostic value
Measured: Up to 28 days
Survival rate
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start10 Dec 2021
- Primary completion1 Jan 2023
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Diehl, PhD, Study chair, AP-HP, Hôpital Européen Georges Pompidou, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074758
- Sponsor's protocol ID
- APHP210693
- Other IDs
- 2021-A01339-32
- Acronym
- VASCOV
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Publications
Diehl JL, Peron N, Chocron R, Debuc B, Guerot E, Hauw-Berlemont C, Hermann B, Augy JL, Younan R, Novara A, Langlais J, Khider L, Gendron N, Goudot G, Fagon JF, Mirault T, Smadja DM. Respiratory mechanics and gas exchanges in the early course of COVID-19 ARDS: a hypothesis-generating study. Ann Intensive Care. 2020 Jul 16;10(1):95. doi: 10.1186/s13613-020-00716-1.
PubMed 32676824Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, Jonigk D. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med. 2020 Jul 9;383(2):120-128. doi: 10.1056/NEJMoa2015432. Epub 2020 May 21.
PubMed 32437596
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the microVAScular Dysfunction in COvid-19 ARDS
- ClinicalTrials.gov ID
- NCT05074758
- Acronym / sponsor ID
- VASCOV / APHP210693
- Keywords
- pulmonary biological markers, alveolar dead-space, circulating endothelial cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 12 Oct 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.
The primary endpoint of this research is to establish that the alveolar dead space is significantly higher in patients with COVID-19 ARDS, compared to patients with non-COVID-19 ARDS.
Secondarily, the investigators want to establish the prognostic value of the alveolar-dead space (measured iteratively) in patients with COVID-19 and non-COVID-19 ARDS, to establish the respective influences of the biological parameters of endothelial damage, of the biological parameters of coagulopathy, of the parameters set on the artificial ventilator on the value of the alveolar dead space; in ARDS patients with COVID-19 and non-COVID-19 ARDS, to establish the prognostic value of the laboratory parameters of endothelial damage and coagulopathy in patients with COVID-19 and non-COVID-19 ARDS.
Detailed description
Endothelial damage and coagulation activation at the lung microvascular level may play an important role in the physiopathology of the COVID-19 ARDS. The project aims to prospectively investigate both bedside pulmonary physiological markers and biological markers of coagulopathy and endothelial dysfunction in COVID-19 and non-COVID-19 ARDS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-COVID-19 ARDS patients | – | Diagnostic Test: alveolar dead-space quantification, Diagnostic Test: Coagulation activation and impaired fibrinolysis explorations, Diagnostic Test: Endothelial activation / endothelial senescence20 patients with acute respiratory distress syndrome (ARDS) unrelated to COVID-19 |
| COVID-19 ARDS patients | – | Diagnostic Test: alveolar dead-space quantification, Diagnostic Test: Coagulation activation and impaired fibrinolysis explorations, Diagnostic Test: Endothelial activation / endothelial senescence20 patients with acute respiratory distress syndrome (ARDS) linked to COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate or severe ARDS linked or not with covid-19
Key inclusion criteria (6 listed)
- Age> 18 years old
- Invasive mechanical ventilation in place for less than 48 hours
- Severe or moderate ARDS (defined according to the Berlin classification)
- Virological confirmation by PCR of SARS-CoV-2 infection (ARDS COVID-19)
- Lack of virological confirmation by PCR of SARS-CoV-2 infection (ARDS not linked to COVID-19)
Key exclusion criteria (3 listed)
- Massive pulmonary embolism
- Chronic respiratory failure under long-term oxygen therapy
- Dying patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alveolar dead-space quantificationmeasurement of alveolar dead-space based on volumetric capnography | Diagnostic test | COVID-19 ARDS patients, non-COVID-19 ARDS patients |
| Coagulation activation and impaired fibrinolysis explorationsblood sampling: * Fibrinolytic components * NETs components * Elastase-derived fragments of proteins of interest | Diagnostic test | COVID-19 ARDS patients, non-COVID-19 ARDS patients |
| Endothelial activation / endothelial senescencecirculating endothelial cells, E-selectin, endoglin, LVEF-A, LVEFR-2, Angiopoietin -1 and -2, cKit and SDF-1 Willebrand factor (activity, antigen, multimeric analysis ) | Diagnostic test | COVID-19 ARDS patients, non-COVID-19 ARDS patients |
Primary outcome
Prognostic value of alveolar dead space
Time frame: Up to 28 days
Recording the exhaled CO2 curve (side-stream capnography method) and volume curve, as determined by the mechanical ventilator, and computing the signals with the arterial CO2 partial pressure, reflecting the partial pressure of CO2 in the alveoli participating in gas exchanges), determined on arterial blood gas (ABG) sampling.
12 secondary outcomes
Prognostic value of the alveolar dead space (measured iteratively)
Time frame: 20 days
Prognostic value of the alveolar dead space (measured iteratively)
Time frame: 28 days
Level of circulating endothelial cells
Time frame: Up to 28 days
Level of progenitor cells
Time frame: Up to 28 days
Level of circulating stem cells
Time frame: Up to 28 days
Level of endothelial proteomics
Time frame: Up to 28 days
Level of D-dimers
Time frame: Up to 28 days
Level of Willebrand Factor
Time frame: Up to 28 days
Level of components of the fibrinolytic system
Time frame: Up to 28 days
Level of fragments of plasminogen
Time frame: Up to 28 days
Level of the components of the NETs (Neutrophil Extracellular Traps)
Time frame: Up to 28 days
Survival rate
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 32676824Diehl JL, Peron N, Chocron R, Debuc B, Guerot E, Hauw-Berlemont C, Hermann B, Augy JL, Younan R, Novara A, Langlais J, Khider L, Gendron N, Goudot G, Fagon JF, Mirault T, Smadja DM. Respiratory mechanics and gas exchanges in the early course of COVID-19 ARDS: a hypothesis-generating study. Ann Intensive Care. 2020 Jul 16;10(1):95. doi: 10.1186/s13613-020-00716-1.
- Background: PubMed 32437596Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, Jonigk D. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med. 2020 Jul 9;383(2):120-128. doi: 10.1056/NEJMoa2015432. Epub 2020 May 21.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Jean-Luc Diehl, PhD study chair
AP-HP, Hôpital Européen Georges Pompidou, Paris
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 ARDS, Human and COVID-19 Acute Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 6 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: finished, as of the sponsor's last update on 8 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value of alveolar dead space (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074758, which also lists 2 linked publications.
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 8 Jul 2026.