Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665752
Status:
TERMINATED
Last Update Posted:
2022-10-06
First Post:
2020-12-11
Brief Title:
Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors a Natural History Observational Study
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
SlowInsufficient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Some people who have had COVID-19 experience changes in the eye Sometimes these changes are subtle and may not affect vision Researchers want to learn how many people experience these eye changes and where in the eye they occur to better understand the outcomes of COVID-19 and its treatments
Objective
To examine possible changes in the eye that might have occurred as a result of COVID-19
Eligibility
Adults age 18 and older who were diagnosed with COVID-19 and recovered
Design
Participants will be screened with a medical history and physical exam They will have blood tests
Participants will have an eye exam Their pupils will be dilated with eye drops Eye pressure and movements will be measured
Participants will have optical coherence tomography Pictures will be taken of the retina and the inside of the eyes
Participants may have fluorescein angiography and indocyanine green angiography They will be given a dye through an intravenous line The dye will travel up to the blood vessels in their eyes Pictures will be taken of the dye as it flows through the blood vessels
Participants may have electroretinography to test the retina They will sit in the dark with their eyes patched for 30 minutes Then they will watch flashing lights while wearing contact lenses that sense signals from the retina
Participants may have adaptive optics-assisted imaging They will look at a specific location while images are taken of the retina
During the study participants will have blood drawn through a needle in their arm Fluid or tissue from the eye may be obtained if participants have a medically needed procedure
Participation will last for 12 months
Some people who have had COVID-19 experience changes in the eye Sometimes these changes are subtle and may not affect vision Researchers want to learn how many people experience these eye changes and where in the eye they occur to better understand the outcomes of COVID-19 and its treatments
Objective
To examine possible changes in the eye that might have occurred as a result of COVID-19
Eligibility
Adults age 18 and older who were diagnosed with COVID-19 and recovered
Design
Participants will be screened with a medical history and physical exam They will have blood tests
Participants will have an eye exam Their pupils will be dilated with eye drops Eye pressure and movements will be measured
Participants will have optical coherence tomography Pictures will be taken of the retina and the inside of the eyes
Participants may have fluorescein angiography and indocyanine green angiography They will be given a dye through an intravenous line The dye will travel up to the blood vessels in their eyes Pictures will be taken of the dye as it flows through the blood vessels
Participants may have electroretinography to test the retina They will sit in the dark with their eyes patched for 30 minutes Then they will watch flashing lights while wearing contact lenses that sense signals from the retina
Participants may have adaptive optics-assisted imaging They will look at a specific location while images are taken of the retina
During the study participants will have blood drawn through a needle in their arm Fluid or tissue from the eye may be obtained if participants have a medically needed procedure
Participation will last for 12 months
Detailed Description:
Study Description
The objective of this study is to understand the rate and extent of ocular involvement in COVID-19 patients and whether SARS-COV-2 can be detected in ocular fluids or tissue in convalescent phase
Objectives
Primary Objective To investigate if COVID survivors show signs of anterior or posterior segment inflammation or other retinochoroidal changes after recovery
Secondary Objectives
To investigate if SARS-Cov-2 can be detected in the ocular fluids or tissues of survivors among patients who undergo medically indicated ocular surgery or diagnostic procedures
Exploratory Objective To investigate whether the use of chloroquineHydroxychloroquine for treatment of COVID-19 is associated with ocular changes
Endpoints
Primary Endpoint Percentage of patients with Ocular exam abnormalities such as conjunctivalcorneal anterior segment choroidal retinal lesions and subclinical findings on OCT FA and ICG
Secondary Endpoints
Correlation of ocular findings with COVID severity by history
Proportion of patients with SARS-COV-2 PCR in ocular fluidtissues among COVID-19 survivors and correlation to clinical characteristics and IgG levels
Study Population
Up to 150 COVID-19 survivors will be recruited
Description of SitesFacilities Enrolling Participants
This protocol will enroll participants at the NIH CC De-identified samples may be received from the New York Medical Center
Study Duration
2 years
Participant Duration
The participants will be asked to come to the NIH CC for one visit A select subgroup of up to 75 participants with positive findings may be asked to return within 12 months from their initial visit
The objective of this study is to understand the rate and extent of ocular involvement in COVID-19 patients and whether SARS-COV-2 can be detected in ocular fluids or tissue in convalescent phase
Objectives
Primary Objective To investigate if COVID survivors show signs of anterior or posterior segment inflammation or other retinochoroidal changes after recovery
Secondary Objectives
To investigate if SARS-Cov-2 can be detected in the ocular fluids or tissues of survivors among patients who undergo medically indicated ocular surgery or diagnostic procedures
Exploratory Objective To investigate whether the use of chloroquineHydroxychloroquine for treatment of COVID-19 is associated with ocular changes
Endpoints
Primary Endpoint Percentage of patients with Ocular exam abnormalities such as conjunctivalcorneal anterior segment choroidal retinal lesions and subclinical findings on OCT FA and ICG
Secondary Endpoints
Correlation of ocular findings with COVID severity by history
Proportion of patients with SARS-COV-2 PCR in ocular fluidtissues among COVID-19 survivors and correlation to clinical characteristics and IgG levels
Study Population
Up to 150 COVID-19 survivors will be recruited
Description of SitesFacilities Enrolling Participants
This protocol will enroll participants at the NIH CC De-identified samples may be received from the New York Medical Center
Study Duration
2 years
Participant Duration
The participants will be asked to come to the NIH CC for one visit A select subgroup of up to 75 participants with positive findings may be asked to return within 12 months from their initial visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000078-EI | None | None | None |