Characterization of the microVAScular Dysfunction in Covid-19 ARDS

ARDS, Human Clinical Trial

— VASCOV  

Official title:

Characterization of the microVAScular Dysfunction in COvid-19 ARDS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05074758
• Other study ID #: APHP210693
• Secondary ID: 2021-A01339-32
• Status: Recruiting
• Start date: December 10, 2021
• Est. completion date: September 10, 2022

Study information

• Verified date: January 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Josephine Braun, PhD
• Phone: 01 44 84 17 38
• Email: josephine.braun[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 10, 2022
• Est. primary completion date: September 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS, Human
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Diagnostic Test:
• alveolar dead-space quantification
measurement of alveolar dead-space based on volumetric capnography
• Coagulation activation and impaired fibrinolysis explorations
blood sampling: Fibrinolytic components NETs components Elastase-derived fragments of proteins of interest
• 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 )

Locations

Country	Name	City	State
France	Hôpital européen Georges Pompidou	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	National Research Agency, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prognostic value of the alveolar dead space (measured iteratively)	To establish the link between alveolar dead-space values and Day 20 mortality	20 days
Secondary	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.	28 days
Secondary	Level of circulating endothelial cells	To describe the biological parameters of endothelial damage and prognostic value	Up to 28 days
Secondary	Level of progenitor cells	To describe the biological parameters of endothelial damage and prognostic value	Up to 28 days
Secondary	Level of circulating stem cells	To describe the biological parameters of endothelial damage and prognostic value	Up to 28 days
Secondary	Level of endothelial proteomics	To describe the biological parameters of endothelial damage and prognostic value	Up to 28 days
Secondary	Level of D-dimers	To describe the biological parameters of endothelial damage and prognostic value	Up to 28 days
Secondary	Level of Willebrand Factor	To describe the biological parameters of endothelial damage and prognostic value	Up to 28 days
Secondary	Level of components of the fibrinolytic system	To describe the biological parameters of endothelial damage and prognostic value	Up to 28 days
Secondary	Level of fragments of plasminogen	To describe the biological parameters of endothelial damage and prognostic value	Up to 28 days
Secondary	Level of the components of the NETs (Neutrophil Extracellular Traps)	To describe the biological parameters of endothelial damage and prognostic value	Up to 28 days
Secondary	Survival rate		90 days