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Protocol Details

Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors, a Natural History, Observational Study

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000078-EI

Sponsoring Institute

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Adults who are or may become unable to consent;
Children

Special Instructions

Currently Not Provided

Keywords

Images

Recruitment Keyword(s)

None

Condition(s)

COVID-19

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Eye Institute

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.

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Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Stated willingness to comply with all study procedures and availability for the duration of the study

2. Male or female, aged 18 or older.

3. 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.

4. Willing to undergo study required testing and blood draw.

5. Willing to have blood samples stored for future research.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Current symptoms consistent with COVID-19 infection.

2. 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.

3. Pregnant and decisionally impaired individuals will be excluded from participation.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Shilpa M. Kodati, M.D.
National Eye Institute (NEI)



Dominic Obiyor, R.N.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10D457
10 Center Drive
Bethesda, Maryland 20892
(301) 435-4556
dominic.obiyor@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04665752

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