Study of Vascular Endothelial Glycocalyx and Ophthalmic Injury, Prospective Cohort of Patients With Prolonged Post-COVID-19 Symptoms

NCT05235698 | Completed

• 1 other identifier: MMF_2021_24
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

COVID-19; Long COVID

Keywords

GlycoCheck; Glycocalix; Ophthalmological effects of long COVID

Outcome Measures

Primary Outcomes (7)

• Capillary density (mm/mm²)

  Assessed by the GlycoCheck

  Baseline

• PBR : Perfused Boundary Region (µm)

  Assessed by the GlycoCheck

  Baseline

• Capillary velocity of red blood cells (µm/s)

  Assessed by the GlycoCheck

  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.

  Baseline

• Presence of vascular hyperpermeability

  Determined by an ophthalmologist with the images of indocyanine green angiography

  Baseline

• Presence of vascular wall abnormalities

  Determined by an ophthalmologist with the results of adaptive optics

  Baseline

• Presence of vessel dilatation

  Determined by an ophthalmologist with the images of OCT (Optical Coherence Tomography)

  Baseline

Study Arms (1)

Patients with long COVID diagnosis

Ophthalmological examinations performed as part of the care Addition of GlycoCheck for the study

Procedure: Ophthalmological examinations; Procedure: GlycoCheck

Interventions

Ophthalmological examinations PROCEDURE

Visual acuity, slit lamp examination, eye pressure, retinophotography, indocyanine green retinal angiography, OCT-A( Optical Coherence Tomography- Angiography), adaptive optics, automated visual field

Patients with long COVID diagnosis

GlycoCheck PROCEDURE

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

Patients with long COVID diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COVID long referred to the Rothschild Hospital for an ophthalmological assessment

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding woman
• Known allergy to indocyanine green

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hospital-Foundation Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martine MAUGET-FAYSSE, MD

  Rothschild Hospital Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 11, 2022
• Study Start: February 10, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

FR (1)