COVID-19 Associated Endothelial Dysfunction Study

NCT04773899 | Completed

• 1 other identifier: 2021-A00330-41
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

SARS-CoV-2 enters human cells through the binding of the spike protein with angiotensin converting enzyme-2 (ACE2), a membrane receptor highly expressed in immune or non-immune cells, and in many organs, including lungs and endothelial cells. In COVID-19 disease, the infection of endothelial might cause an acute endothelial dysfunction. The objective of this study is to demonstrate that patients COVID19 (+) hospitalized in ICU present an acute endothelial dysfunction (compared with COVID19 (-) also hospitalized in ICU). This acute endothelial dysfunction could lead to organ failure, systemic immune dysregulation and thrombosis.

Conditions

Covid19; Microcirculation

Outcome Measures

Primary Outcomes (1)

• Endothelial function measured by Near-infrared spectroscopy (NIRS)

  Measure : Saturation Tissue (StO2) after a vascular occlusion test (VOT)

  within 72 hours of admission in Intensive Care Unit (ICU)

Secondary Outcomes (12)

• Endothelial function measured by perfusion index

  within 72 hours of admission in ICU

• Microvascular reactivity measured laser speckle contrast imaging

  within 72 hours of admission in ICU

• Morphological analysis by Sublingual videomicroscopy

  within 72 hours of admission in ICU

• Morphological analysis by Sublingual videomicroscopy

  within 72 hours of admission in ICU

• Inflammatory status

  Inclusion

Study Arms (3)

Cohort C1

OTHER

COVID19 (+) ICU patients with COVID19 pneumonia.

Diagnostic Test: Procedure : Multimodal microvascular assessment at study inclusion

Cohort C2

OTHER

COVID19 (-) matched ICU patients

Diagnostic Test: Procedure : Multimodal microvascular assessment at study inclusion

Cohort C3

OTHER

COVID19 (-) ASA 1 non-hospitalized patients

Diagnostic Test: Procedure : Multimodal microvascular assessment at study inclusion

Interventions

Procedure : Multimodal microvascular assessment at study inclusion DIAGNOSTIC_TEST

* Vascular occlusion test (VOT) performed on the arm. Measurement of the quality of tissue reperfusion by NIRS on the thenar eminence and the digital perfusion index. * Microcirculation reactivity is measured for each patient with a laser speckle contrast imaging (LSCI) placed on the forearm. Tests will be performed for evaluation of microvascular reactivity: Acetylcholine and Nitroprusside Iontophoresis. * Morphological analysis of the microcirculation by sublingual videomicroscopy.

Cohort C1; Cohort C2; Cohort C3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient (≥ 18 ans)
• Affiliation to the French National Healthcare System
• Voluntary patient who have given oral consent
• Cohort C1, COVID19 (+) patients hospitalized in ICU :
• Patient presenting SARS-COV2 pneumonia diagnosed by CT scan or by COVID-19 PCR test.
• Cohort C2, COVID19 (-) patients hospitalized in ICU :
• All the CT scans possibly performed since the acute event do not show COVID19 pulmonary lesions
• Matching with the cases C1 COVID 19 (+) patients on sex, age (threshold at 65 years), treated hypertension, treated diabetes mellitus.
• Cohort C3, elective surgery patients who are not hospitalized in ICU :
• ASA 1 classification (no major comorbidity, a normaly healthy patient)
• Asymptomatic to COVID19 according to French Anesthesiology Society 2020 :
• No major symptoms among : measured fever \> 38°C, dry cough, shortness of breath or high respiratory rate (\>20/min), anosmia, ageusia
• No more than one minor symptom among : sore throat, rhinorrhea, chest pain, myalgia, general alteration or severe tiredness, confusion, disorientation, headache, diarrhea, nausea or/and vomiting, rash/ frostbite/cracking on fingers or hand
• End-stage kidney disease with dialysis
• Patient with haemodynamic failure treated by norepinephrine

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (2)

UH Angers

Angers, 49933, France

Location

Hopital E.Herriot - Hospices Civils de Lyon

Lyon, 69437, France

Location

Related Publications (1)

• Abrard S, Coquet T, Riou J, Rineau E, Hersant J, Vincent A, Cordoval J, Jacquet-Lagreze M, Allaouchiche B, Lukaszewicz AC, Henni S. DETECTION AND QUANTIFICATION OF MICROCIRCULATORY DYSFUNCTION IN SEVERE COVID-19 NOT REQUIRING MECHANICAL VENTILATION: A THREE-ARM COHORT STUDY. Shock. 2024 Nov 1;62(5):673-681. doi: 10.1097/SHK.0000000000002451. Epub 2024 Aug 12. English, French.

  PMID: 39158987 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Samir HENNI, MD PhD

  UH Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 26, 2021
• Study Start: October 22, 2021
• Primary Completion: October 21, 2022
• Study Completion: December 21, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)