COVID-19NCT04665752
Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors
An observational study of COVID-19, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2021to 28 Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with COVID-19 and at least 30 days symptom-free.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older.
- History of positive PCR or positive IgG for SARS-CoV-2 cases and if known history of COVID-19 infection, at least 30 days passed since a positive PCR for SARS-COV-2 and have been asymptomatic for at least 10 days.
- Willing to undergo study required testing and blood draw.
- Willing to have blood samples stored for future research.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current symptoms consistent with COVID-19 infection.
- Any condition or event that, in the PI s opinion, may substantially increase the risk associated with study participation or compromise the study's scientific objectives. Conditions that exclude a subject are considered to be unlikely, but an example would include having an acute respiratory infection or recent exposure that would make it unsafe to perform study procedures or obtain blood samples.
- Pregnant and decisionally impaired individuals will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors, a Natural History, Observational Study
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.
Read more
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.
Read the 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 chloroquine/Hydroxychloroquine for treatment of COVID-19 is associated with ocular changes.
Endpoints:
Primary Endpoint: Percentage of patients with Ocular exam abnormalities such as conjunctival/corneal, 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 fluid/tissues 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 Sites/Facilities 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.
- Conditions
- COVID-19
- Keywords
- Images, Natural History
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected Participants | Participants previously diagnosed with COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants
Percentage of participants with ocular exam abnormalities, such as conjunctival/corneal anterior segment, choroidal, retinal lesions and subclinical findings on OCT, FA, and ICG.
Measured: Over the study duration
Secondary outcomes (2)
Correlation of findings
Correlation of ocular findings with COVID severity
Measured: Over the study duration
Proportion of patients
Proportion of patients with +SARS-COV-2 PCR in ocular fluid/tissues among COVID-19 survivors and correlation to clinical characteristics and IgG levels.
Measured: Over the study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start2 Feb 2021
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Why it stopped: Slow/Insufficient accrual
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.
- 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
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Shilpa M Kodati, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665752
- Sponsor's protocol ID
- 10000078
- Other IDs
- 000078-EI
- Status last verified
- Oct 2022
- First submitted
- 11 Dec 2020
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors, a Natural History, Observational Study
- ClinicalTrials.gov ID
- NCT04665752
- Acronym / sponsor ID
- 10000078
- Conditions
- COVID-19
- Keywords
- Images, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow/Insufficient accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 14 Dec 2020 (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.
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.
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 chloroquine/Hydroxychloroquine for treatment of COVID-19 is associated with ocular changes.
Endpoints:
Primary Endpoint: Percentage of patients with Ocular exam abnormalities such as conjunctival/corneal, 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 fluid/tissues 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 Sites/Facilities 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Affected Participants | – | –Participants previously diagnosed with COVID-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with COVID-19 and at least 30 days symptom-free.
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older.
- History of positive PCR or positive IgG for SARS-CoV-2 cases and if known history of COVID-19 infection, at least 30 days passed since a positive PCR for SARS-COV-2 and have been asymptomatic for at least 10 days.
- Willing to undergo study required testing and blood draw.
Key exclusion criteria (4 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current symptoms consistent with COVID-19 infection.
- Any condition or event that, in the PI s opinion, may substantially increase the risk associated with study participation or compromise the study's scientific objectives. Conditions that exclude a subject are considered to be unlikely, but an example would include having an acute respiratory infection or recent exposure that would make it unsafe to perform study procedures or obtain blood samples.
- Pregnant and decisionally impaired individuals will be excluded from participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants
Time frame: Over the study duration
Percentage of participants with ocular exam abnormalities, such as conjunctival/corneal anterior segment, choroidal, retinal lesions and subclinical findings on OCT, FA, and ICG.
2 secondary outcomes
Correlation of findings
Time frame: Over the study duration
Proportion of patients
Time frame: Over the study duration
Results and safety
The study was stopped early (reason given: Slow/Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Shilpa M Kodati, M.D. principal investigator
National Eye Institute (NEI)
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, run by National Eye Institute (NEI) at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 6 Oct 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 United States. 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 was stopped early (reason given: Slow/Insufficient accrual). Results are not available in the source record.
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?
Percentage of participants (time frame: Over the study duration). 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 6 Oct 2022.