COVID-19GLYCOVLONGNCT05235698
Study of Vascular Endothelial Glycocalyx and Ophthalmic Injury, Prospective Cohort of Patients With Prolonged Post-COVID-19 Symptoms
An observational study of COVID-19 and Long COVID, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The glycocalyx is a membrane coat composed of glycoproteins attached to the surface of cell membranes. Recent publications have drawn attention to the potential role of a degradation of the endothelial glycocalyx (a kind of gel that lines all the vessels of the body) during the SARS-CoV-2 (Severe Acute Respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Long COVID
- What is being tested?
- Ophthalmological examinations and GlycoCheck
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2022to 1 Jun 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with COVID long referred to the Rothschild Hospital for an ophthalmological assessment
Who may be able to join
- Diagnosis of long COVID, namely:
- Initial symptomatic episode of COVID-19: Either confirmed by at least one of the following criteria: Positive SARS-Cov-2 PCR (polymerase chain reaction, positive SARS-CoV-2 antigenic test, prolonged anosmia/ageusia of abrupt onset, typical chest CT (computerized tomography) scan (bilateral ground glass pneumonia...), or probable by the association of at least 3 criteria, of sudden onset, in an epidemic context, among: fever, headache, fatigue, myalgia, dyspnea, cough, chest pain, diarrhea, odynophagia. A positive SARS-CoV-2 serology may help in this diagnosis.
- Presence of at least one of the initial symptoms beyond 4 weeks after the onset of the acute phase of the disease
- Initial and prolonged symptoms not explained by another diagnosis with no known relationship to COVID-19
- Referred for ophthalmologic evaluation to the Rothschild Foundation Hospital
- Expressed consent to participate in the study
Who cannot join
- Pregnant or breastfeeding woman
- Known allergy to indocyanine green
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Vascular Endothelial Glycocalyx and Ophthalmic Injury in a Single-center, Cross-sectional, Prospective Cohort of Patients With Prolonged Post-COVID-19 Symptoms
The glycocalyx is a membrane coat composed of glycoproteins attached to the surface of cell membranes. Recent publications have drawn attention to the potential role of a degradation of the endothelial glycocalyx (a kind of gel that lines all the vessels of the body) during the SARS-CoV-2 (Severe Acute Respiratory Syndrome - coronavirus 2) epidemic.
The work of Yamaoka-Tojo et al. reveals vascular endothelial dysfunction in patients at high risk for developing a severe form of COVID 19. This observation prompts further investigation of vascular endothelial function in SARS-CoV-2-infected patients, and particularly those with long COVID.
Read more
As of the end of the first COVID-19 epidemic wave in May 2020, persistence of symptoms several weeks or months after the first manifestations of COVID-19 was described in more than 20% of patients after 5 weeks and in more than 10% after 3 months). The term "long COVID" describes this phenomenon of prolonged symptoms following COVID-19.
The French National Authority for Health has established criteria to identify people with prolonged symptoms after an initial episode of clinically and/or biologically documented COVID-19: an initial symptomatic episode, the presence of at least one of the initial symptoms beyond 4 weeks after the onset of the acute phase of the disease, and initial and prolonged symptoms not explained by another diagnosis not known to be related to COVID-19.
Among the observations reported in patients with long COVID, ophthalmic involvement is poorly described.
A team of ophthalmologists of the Rothschild Foundation has demonstrated (using indocyanine green angiography, adaptive optics and optical coherence tomography techniques) disorders of the choroidal circulation, with abnormalities of the vascular walls, presence of "pachyvessels" and "caverns", in COVID-positive patients hospitalized at 6 months of their hospitalization.
Read the detailed description
The aim of this study is to extend the exploration of the microvascular system by a microscopic imaging technique of sublingual blood capillaries. The GlycoCheck is a medical device with CE marking. It is the only all-in-one automated system that includes patented software technology embedded in a dedicated computer, a digital video microscope camera, and the calculation of a MicroVascular Health Score™. The video microscope camera is placed under the tongue, showing the live movement of red blood cells as they move through the microvessels. Higher scores indicate a healthier microvascular system. When the transparent glycocalyx lining of the microvascular system is healthy, so are the blood vessels, which are essential for health and vitality. A clinical video microscope detects erythrocytes in the small sublingual blood vessels. Then the GlycoCheck software records, detects and analyzes blood vessels from 5 to 25 µm in diameter. The automatic analysis consists of the detection of the central lumen of each blood vessel and the detection of the outer limits of the erythrocytes. The distance between the red cell column and this outer boundary is identified as the Perfused Boundary Region (PBR). The PBR value is calculated over 3000 individual positions, which makes the measurement results sensitive, but highly reproducible. A higher PBR value corresponds to a proportional decrease in the thickness of the glycocalyx layer. There are 3000 vascular segments per test. These segments process 3,000,000 capillary markers that track the movement of red blood cells and how they interact with the endothelial glycocalyx. Results are provided within minutes of test completion and a microvascular health report is created. This medical device has already been used in numerous clinical studies.
The main objective is to search for associations between possible ocular abnormalities and possible glycocalyx abnormalities evaluated by the GlycoCheck
- Conditions
- COVID-19, Long COVID
- Being tested
- Ophthalmological examinations, GlycoCheck
- Keywords
- GlycoCheck, Glycocalix, Ophthalmological effects of long COVID
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmological examinationsProcedure or surgery
Visual acuity, slit lamp examination, eye pressure, retinophotography, indocyanine green retinal angiography, OCT-A( Optical Coherence Tomography- Angiography), adaptive optics, automated visual field
GlycoCheckProcedure or surgery
Evaluation of the glycocalyx of sublingual capillaries with the GlycoCheck :
A sidestream dark field camera, coupled with GlycoCheck™ software is used to visualize the patient's sublingual microvascularization
| Study group | Role | What they receive |
|---|---|---|
| Patients with long COVID diagnosis | Ophthalmological examinations performed as part of the care Addition of GlycoCheck for the study Receives: Procedure: Ophthalmological examinations; Procedure: GlycoCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary density (mm/mm²)
Assessed by the GlycoCheck
Measured: Baseline
PBR : Perfused Boundary Region (µm)
Assessed by the GlycoCheck
Measured: Baseline
Capillary velocity of red blood cells (µm/s)
Assessed by the GlycoCheck
Measured: Baseline
Micro Vascular Health Score
Assessed by the GlycoCheck:
Score from 0 to 10. 10 is the best score for Micro Vascular Health and 0 the worse.
Measured: Baseline
Presence of vascular hyperpermeability
Determined by an ophthalmologist with the images of indocyanine green angiography
Measured: Baseline
Presence of vascular wall abnormalities
Determined by an ophthalmologist with the results of adaptive optics
Measured: Baseline
Presence of vessel dilatation
Determined by an ophthalmologist with the images of OCT (Optical Coherence Tomography)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start10 Feb 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine MAUGET-FAYSSE, MD, Principal investigator, Rothschild Hospital Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235698
- Sponsor's protocol ID
- MMF_2021_24
- Acronym
- GLYCOVLONG
- Status last verified
- Jun 2022
- First submitted
- 10 Feb 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Vascular Endothelial Glycocalyx and Ophthalmic Injury in a Single-center, Cross-sectional, Prospective Cohort of Patients With Prolonged Post-COVID-19 Symptoms
- ClinicalTrials.gov ID
- NCT05235698
- Acronym / sponsor ID
- GLYCOVLONG / MMF_2021_24
- Conditions
- COVID-19, Long COVID
- Keywords
- GlycoCheck, Glycocalix, Ophthalmological effects of long COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The glycocalyx is a membrane coat composed of glycoproteins attached to the surface of cell membranes. Recent publications have drawn attention to the potential role of a degradation of the endothelial glycocalyx (a kind of gel that lines all the vessels of the body) during the SARS-CoV-2 (Severe Acute Respiratory Syndrome - coronavirus 2) epidemic.
The work of Yamaoka-Tojo et al. reveals vascular endothelial dysfunction in patients at high risk for developing a severe form of COVID 19. This observation prompts further investigation of vascular endothelial function in SARS-CoV-2-infected patients, and particularly those with long COVID.
As of the end of the first COVID-19 epidemic wave in May 2020, persistence of symptoms several weeks or months after the first manifestations of COVID-19 was described in more than 20% of patients after 5 weeks and in more than 10% after 3 months). The term "long COVID" describes this phenomenon of prolonged symptoms following COVID-19.
The French National Authority for Health has established criteria to identify people with prolonged symptoms after an initial episode of clinically and/or biologically documented COVID-19: an initial symptomatic episode, the presence of at least one of the initial symptoms beyond 4 weeks after the onset of the acute phase of the disease, and initial and prolonged symptoms not explained by another diagnosis not known to be related to COVID-19.
Among the observations reported in patients with long COVID, ophthalmic involvement is poorly described.
A team of ophthalmologists of the Rothschild Foundation has demonstrated (using indocyanine green angiography, adaptive optics and optical coherence tomography techniques) disorders of the choroidal circulation, with abnormalities of the vascular walls, presence of "pachyvessels" and "caverns", in COVID-positive patients hospitalized at 6 months of their hospitalization.
Detailed description
The aim of this study is to extend the exploration of the microvascular system by a microscopic imaging technique of sublingual blood capillaries. The GlycoCheck is a medical device with CE marking. It is the only all-in-one automated system that includes patented software technology embedded in a dedicated computer, a digital video microscope camera, and the calculation of a MicroVascular Health Score™. The video microscope camera is placed under the tongue, showing the live movement of red blood cells as they move through the microvessels. Higher scores indicate a healthier microvascular system. When the transparent glycocalyx lining of the microvascular system is healthy, so are the blood vessels, which are essential for health and vitality. A clinical video microscope detects erythrocytes in the small sublingual blood vessels. Then the GlycoCheck software records, detects and analyzes blood vessels from 5 to 25 µm in diameter. The automatic analysis consists of the detection of the central lumen of each blood vessel and the detection of the outer limits of the erythrocytes. The distance between the red cell column and this outer boundary is identified as the Perfused Boundary Region (PBR). The PBR value is calculated over 3000 individual positions, which makes the measurement results sensitive, but highly reproducible. A higher PBR value corresponds to a proportional decrease in the thickness of the glycocalyx layer. There are 3000 vascular segments per test. These segments process 3,000,000 capillary markers that track the movement of red blood cells and how they interact with the endothelial glycocalyx. Results are provided within minutes of test completion and a microvascular health report is created. This medical device has already been used in numerous clinical studies.
The main objective is to search for associations between possible ocular abnormalities and possible glycocalyx abnormalities evaluated by the GlycoCheck
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with long COVID diagnosis | – | Procedure: Ophthalmological examinations, Procedure: GlycoCheckOphthalmological examinations performed as part of the care Addition of GlycoCheck for the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID long referred to the Rothschild Hospital for an ophthalmological assessment
Key inclusion criteria (6 listed)
- Diagnosis of long COVID, namely:
- Referred for ophthalmologic evaluation to the Rothschild Foundation Hospital
- Expressed consent to participate in the study
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding woman
- Known allergy to indocyanine green
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmological examinationsVisual acuity, slit lamp examination, eye pressure, retinophotography, indocyanine green retinal angiography, OCT-A( Optical Coherence Tomography- Angiography), adaptive optics, automated visual field | Procedure or surgery | Patients with long COVID diagnosis |
| GlycoCheckEvaluation of the glycocalyx of sublingual capillaries with the GlycoCheck : A sidestream dark field camera, coupled with GlycoCheck™ software is used to visualize the patient's sublingual microvascularization | Procedure or surgery | Patients with long COVID diagnosis |
Primary outcome
Capillary density (mm/mm²)
Time frame: Baseline
Assessed by the GlycoCheck
PBR : Perfused Boundary Region (µm)
Time frame: Baseline
Assessed by the GlycoCheck
Capillary velocity of red blood cells (µm/s)
Time frame: Baseline
Assessed by the GlycoCheck
Micro Vascular Health Score
Time frame: Baseline
Assessed by the GlycoCheck: Score from 0 to 10. 10 is the best score for Micro Vascular Health and 0 the worse.
Presence of vascular hyperpermeability
Time frame: Baseline
Determined by an ophthalmologist with the images of indocyanine green angiography
Presence of vascular wall abnormalities
Time frame: Baseline
Determined by an ophthalmologist with the results of adaptive optics
Presence of vessel dilatation
Time frame: Baseline
Determined by an ophthalmologist with the images of OCT (Optical Coherence Tomography)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine MAUGET-FAYSSE, MD principal investigator
Rothschild Hospital Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Long COVID, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site 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 6 inclusion and 2 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 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Capillary density (mm/mm²) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2022.