COVID-19 Clinical Trial
— GLYCOVLONGOfficial 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
NCT number | NCT05235698 |
Other study ID # | MMF_2021_24 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 10, 2022 |
Est. completion date | June 1, 2022 |
Verified date | June 2022 |
Source | Fondation Ophtalmologique Adolphe de Rothschild |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | June 1, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of long COVID, namely: 1. 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. 2. Presence of at least one of the initial symptoms beyond 4 weeks after the onset of the acute phase of the disease 3. 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 Exclusion Criteria: - Pregnant or breastfeeding woman - Known allergy to indocyanine green |
Country | Name | City | State |
---|---|---|---|
France | Hospital-Foundation Adolphe de Rothschild | Paris |
Lead Sponsor | Collaborator |
---|---|
Fondation Ophtalmologique Adolphe de Rothschild |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Capillary density (mm/mm²) | Assessed by the GlycoCheck | Baseline | |
Primary | PBR : Perfused Boundary Region (µm) | Assessed by the GlycoCheck | Baseline | |
Primary | Capillary velocity of red blood cells (µm/s) | Assessed by the GlycoCheck | Baseline | |
Primary | 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 | |
Primary | Presence of vascular hyperpermeability | Determined by an ophthalmologist with the images of indocyanine green angiography | Baseline | |
Primary | Presence of vascular wall abnormalities | Determined by an ophthalmologist with the results of adaptive optics | Baseline | |
Primary | Presence of vessel dilatation | Determined by an ophthalmologist with the images of OCT (Optical Coherence Tomography) | Baseline |
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