NCT05074758

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 10, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

July 19, 2021

Last Update Submit

January 17, 2022

Conditions

ARDS, HumanCOVID-19 Acute Respiratory Distress Syndrome

Keywords

pulmonary biological markersalveolar dead-spacecirculating endothelial cells

Outcome Measures

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.

    Up to 28 days

Secondary Outcomes (12)

  • Prognostic value of the alveolar dead space (measured iteratively)

    20 days

  • Prognostic value of the alveolar dead space (measured iteratively)

    28 days

  • Level of circulating endothelial cells

    Up to 28 days

  • Level of progenitor cells

    Up to 28 days

  • Level of circulating stem cells

    Up to 28 days

  • +7 more secondary outcomes

Study Arms (2)

non-COVID-19 ARDS patients

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

Diagnostic Test: alveolar dead-space quantificationDiagnostic Test: Coagulation activation and impaired fibrinolysis explorationsDiagnostic 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 quantificationDiagnostic Test: Coagulation activation and impaired fibrinolysis explorationsDiagnostic Test: Endothelial activation / endothelial senescence

Interventions

alveolar dead-space quantificationDIAGNOSTIC_TEST

measurement of alveolar dead-space based on volumetric capnography

COVID-19 ARDS patientsnon-COVID-19 ARDS patients
Coagulation activation and impaired fibrinolysis explorationsDIAGNOSTIC_TEST

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

COVID-19 ARDS patientsnon-COVID-19 ARDS patients
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 )

COVID-19 ARDS patientsnon-COVID-19 ARDS patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital européen Georges Pompidou

Paris, 75015, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32676824BACKGROUND

  • 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.

    PMID: 32437596BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples citrated tubes blood samples EDTA tubes

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Jean-Luc Diehl, PhD

    AP-HP, Hôpital Européen Georges Pompidou, Paris

    STUDY CHAIR

Central Study Contacts

Josephine Braun, PhD

CONTACT

01 44 84 17 38josephine.braun@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

October 12, 2021

Study Start

December 10, 2021

Primary Completion

September 10, 2022

Study Completion

September 10, 2022

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Two years after the last publication
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).

Locations

FR(1)