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Covid19CAUSEDNCT04773899

COVID-19 Associated Endothelial Dysfunction Study

A study testing Procedure : Multimodal microvascular assessment at study inclusion in people with Covid19 and Microcirculation, run by University Hospital, Angers at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19, Microcirculation
What is being tested?
Procedure : Multimodal microvascular assessment at study inclusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesFrance
Study dates
22 Oct 2021to 21 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 admitted to ICU within 72 hours before inclusion
  • Patient presenting SARS-COV2 pneumonia diagnosed by CT scan or by COVID-19 PCR test.
Show all 27Show fewer
  • Cohort C2, COVID19 (-) patients hospitalized in ICU :
  • Patient admitted to ICU within 72 hours before inclusion
  • All COVID19 PCR tests carried out in the 15 days prior inclusion are negative
  • 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
  • No positive COVID19 PCR test within 15 days prior to inclusion
  • Non-inclusion criteria :
  • Proven sepsis (Procalcitonin >1.0 µg/l) in the 24 hours prior to inclusion
  • End-stage kidney disease with dialysis
  • Patient with haemodynamic failure treated by norepinephrine
  • Patient with traumatic brain injury
  • Intubated patient and/or sedated
  • Pregnant woman, parturient and nursing mother
  • Person restricted in liberty by an administrative or judicial decision
  • Patient concerned with admission for psychiatric care
  • Adult person subject to a legal protection measure or unable to express consent

Who cannot join

  • Cohorts C2 and C3 : positive COVID-19 PCR test within 5 days after inclusion

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • UH Angers

    Angers, 49933

  • Hopital E.Herriot - Hospices Civils de Lyon

    Lyon, 69437

Other trials in France

About this study

Official title: L'Étude de la Dysfonction endothéliale Dans la Maladie à COVID-19 Chez Des Patients en Soins Critiques.

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.

Read the detailed description

This cohort study compares 3 exposure cohorts :

Cohort C1 includes COVID19 (+) patients admitted in ICU in whom the diagnosis of COVID19 pneumonia was confirmed.

Cohort C2 includes COVID 19 (-) matched patients also admitted in ICU.

Cohort C3 is a control group. Patients with few comorbidities, ASA 1, recruited during preoperative assessment for elective surgery.

Eligible patients are included within 72 hours of ICU admission (C1, C2) or during the preoperative assessment (C3). Oral consent is needed after complete explanation of the protocol.

During inclusion visit (V0), patient characteristics as treatments, medical history, clinical and biological data are registered.

Microcirculation is assessed for each patient directly after inclusion.

For patients in C1 and C2 a follow-up is planned. This visit (V1) occurs when the patient is discharged from ICU or the day of his death if it occurs in ICU. In case of prolonged stay in ICU, V1 is carried out 2 months after inclusion. During V1, arterial and/or venous thromboembolic events and mortality in ICU is registered.

For Patients in C3, no follow-up is planned.

Being tested
Procedure : Multimodal microvascular assessment at study inclusion
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Procedure : Multimodal microvascular assessment at study inclusionDiagnostic 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.
Study groups in NCT04773899
Study groupRoleWhat they receive
Cohort C1OtherCOVID19 (+) ICU patients with COVID19 pneumonia.
Receives: Diagnostic Test: Procedure : Multimodal microvascular assessment at study inclusion
Cohort C2OtherCOVID19 (-) matched ICU patients
Receives: Diagnostic Test: Procedure : Multimodal microvascular assessment at study inclusion
Cohort C3OtherCOVID19 (-) ASA 1 non-hospitalized patients
Receives: Diagnostic Test: Procedure : Multimodal microvascular assessment at study inclusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endothelial function measured by Near-infrared spectroscopy (NIRS)

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

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

Secondary outcomes (12)

  1. Endothelial function measured by perfusion index

    measure : Perfusion index after a vascular occlusion test (VOT)

    Measured: within 72 hours of admission in ICU

  2. Microvascular reactivity measured laser speckle contrast imaging

    measure : Vasodilation after iontophoresis of Acetylcholine and Nitroprusside

    Measured: within 72 hours of admission in ICU

  3. Morphological analysis by Sublingual videomicroscopy

    measure : Microvascular flow index (MFI)

    Measured: within 72 hours of admission in ICU

  4. Morphological analysis by Sublingual videomicroscopy

    measure : Perfused vessel density (PVD)

    Measured: within 72 hours of admission in ICU

  5. Inflammatory status

    measure : C-reactive protein level

    Measured: Inclusion

  6. Inflammatory status

    measure : neutrophil to lymphocyte ratio

    Measured: Inclusion

  7. Prothrombotic condition

    measure : D-Dimer Level and

    Measured: Inclusion

  8. Thrombotic events

    measure : All arterial and/or venous thromboembolic events since acute episode

    Measured: Inclusion (V0) up to 8 weeks maximum

  9. Severity of lung disease

    measure : PaO2/FiO2 ratio

    Measured: Inclusion

  10. Severity of lung disease

    measure : percentage of pulmonary lesions assessed by CT scan at the ICU admission.

    Measured: Inclusion

  11. Mortality

    measure : Mortality in ICU

    Measured: Up to 8 weeks after inclusion

  12. Organ failure

    measure : Sequential Organ Failure Assessment (SOFA) Score, minimum value 0 and maximum value 24. The higher score means a worse outcome.

    Measured: Inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2021
  2. Study start22 Oct 2021
  3. Primary completion21 Oct 2022
  4. Study completion21 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04773899
Sponsor's protocol ID
2021-A00330-41
Acronym
CAUSED
Status last verified
May 2023
First submitted
19 Feb 2021
Last updated
6 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39158987

Questions about this trial

What is this clinical trial studying?

A study testing Procedure : Multimodal microvascular assessment at study inclusion in people with Covid19 and Microcirculation, run by University Hospital, Angers at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endothelial function measured by Near-infrared spectroscopy (NIRS) (time frame: within 72 hours of admission in Intensive Care Unit (ICU)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04773899, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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COVID-19 Associated Endothelial Dysfunction Study | AzTrials