CClinicalTrials.gg
CompletedNCT05074758VASCOVUpdated Jul 8, 2026

Characterization of the microVAScular Dysfunction in Covid-19 ARDS

An observational study in ARDS, Human and COVID-19 Acute Respiratory Distress Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
39
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • ARDS, Human
  • COVID-19 Acute Respiratory Distress Syndrome

Keywords

  • pulmonary biological markers
  • alveolar dead-space
  • circulating endothelial cells
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 39 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with moderate or severe ARDS linked or not with covid-19

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Massive pulmonary embolism
  • Chronic respiratory failure under long-term oxygen therapy
  • Dying patient
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
39 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • non-COVID-19 ARDS patients

    20 patients with acute respiratory distress syndrome (ARDS) unrelated to COVID-19

    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

    Diagnostic Test: alveolar dead-space quantification · Diagnostic Test: Coagulation activation and impaired fibrinolysis explorations · Diagnostic Test: Endothelial activation / endothelial senescence

Interventions

  • Diagnostic testalveolar dead-space quantification

    measurement of alveolar dead-space based on volumetric capnography

  • Diagnostic testCoagulation activation and impaired fibrinolysis explorations

    blood sampling: * Fibrinolytic components * NETs components * Elastase-derived fragments of proteins of interest

  • Diagnostic testEndothelial activation / endothelial senescence

    circulating endothelial cells, E-selectin, endoglin, LVEF-A, LVEFR-2, Angiopoietin -1 and -2, cKit and SDF-1 Willebrand factor (activity, antigen, multimeric analysis )

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 28 days

Secondary outcomes

  1. Prognostic value of the alveolar dead space (measured iteratively)

    To establish the link between alveolar dead-space values and Day 20 mortality

    Time frame: 20 days

  2. 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.

    Time frame: 28 days

  3. Level of circulating endothelial cells

    To describe the biological parameters of endothelial damage and prognostic value

    Time frame: Up to 28 days

  4. Level of progenitor cells

    To describe the biological parameters of endothelial damage and prognostic value

    Time frame: Up to 28 days

  5. Level of circulating stem cells

    To describe the biological parameters of endothelial damage and prognostic value

    Time frame: Up to 28 days

  6. Level of endothelial proteomics

    To describe the biological parameters of endothelial damage and prognostic value

    Time frame: Up to 28 days

  7. Level of D-dimers

    To describe the biological parameters of endothelial damage and prognostic value

    Time frame: Up to 28 days

  8. Level of Willebrand Factor

    To describe the biological parameters of endothelial damage and prognostic value

    Time frame: Up to 28 days

  9. Level of components of the fibrinolytic system

    To describe the biological parameters of endothelial damage and prognostic value

    Time frame: Up to 28 days

  10. Level of fragments of plasminogen

    To describe the biological parameters of endothelial damage and prognostic value

    Time frame: Up to 28 days

  11. Level of the components of the NETs (Neutrophil Extracellular Traps)

    To describe the biological parameters of endothelial damage and prognostic value

    Time frame: Up to 28 days

  12. Survival rate

    Time frame: 90 days

07

Study locations

1 site
  • Hôpital européen Georges Pompidou
    Paris, Paris 75015, France
08

References and documents

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 32676824 ↗
  • Ackermann 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 ↗

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05074758
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
National Research Agency, France
Responsible party
Sponsor
First posted
Oct 12, 2021
Start date
Dec 10, 2021
Primary completion
Jan 1, 2023
Completion
Mar 6, 2023
Last update
Jul 8, 2026

Study contacts

Jean-Luc Diehl, PhD
study chair · AP-HP, Hôpital Européen Georges Pompidou, Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion