Characterization of the microVAScular Dysfunction in Covid-19 ARDS (VASCOV)

January 17, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou
        • Contact:
          • Diehl Jean-Luc, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
non-COVID-19 ARDS patients
20 patients with acute respiratory distress syndrome (ARDS) unrelated to COVID-19
Diagnostic test: alveolar dead-space quantification
measurement of alveolar dead-space based on volumetric capnography
Diagnostic test: Coagulation activation and impaired fibrinolysis explorations

blood sampling:

  • Fibrinolytic components
  • NETs components
  • Elastase-derived fragments of proteins of interest
Diagnostic test: Endothelial 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 )
COVID-19 ARDS patients
20 patients with acute respiratory distress syndrome (ARDS) linked to COVID-19
Diagnostic test: alveolar dead-space quantification
measurement of alveolar dead-space based on volumetric capnography
Diagnostic test: Coagulation activation and impaired fibrinolysis explorations

blood sampling:

  • Fibrinolytic components
  • NETs components
  • Elastase-derived fragments of proteins of interest
Diagnostic test: Endothelial 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 )

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prognostic value of the alveolar dead space (measured iteratively)
Time Frame: 20 days
To establish the link between alveolar dead-space values and Day 20 mortality
20 days
Prognostic value of the alveolar dead space (measured iteratively)
Time Frame: 28 days
To establish the link between alveolar dead-space values and Day 20 mortality and Day-28 invasive ventilator-free days.
28 days
Level of circulating endothelial cells
Time Frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
Up to 28 days
Level of progenitor cells
Time Frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
Up to 28 days
Level of circulating stem cells
Time Frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
Up to 28 days
Level of endothelial proteomics
Time Frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
Up to 28 days
Level of D-dimers
Time Frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
Up to 28 days
Level of Willebrand Factor
Time Frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
Up to 28 days
Level of components of the fibrinolytic system
Time Frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
Up to 28 days
Level of fragments of plasminogen
Time Frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
Up to 28 days
Level of the components of the NETs (Neutrophil Extracellular Traps)
Time Frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
Up to 28 days
Survival rate
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Research Agency, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jean-Luc Diehl, PhD, AP-HP, Hôpital Européen Georges Pompidou, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP210693
  • 2021-A01339-32 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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