Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04665752
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : December 16, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

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.


Condition or disease
COVID-19

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors, a Natural History, Observational Study
Actual Study Start Date : February 2, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Affected Participants
Participants previously diagnosed with COVID-19.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Correlation of findings [ Time Frame: Over the study duration ]
    Correlation of ocular findings with COVID severity

  2. Proportion of patients [ Time Frame: Over the study duration ]
    Proportion of patients with +SARS-COV-2 PCR in ocular fluid/tissues among COVID-19 survivors and correlation to clinical characteristics and IgG levels.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with COVID-19 and at least 30 days symptom-free.
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665752


Contacts
Layout table for location contacts
Contact: Dominic Obiyor, R.N. (301) 435-4556 dominic.obiyor@nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
Layout table for investigator information
Principal Investigator: Shilpa M Kodati, M.D. National Eye Institute (NEI)
Additional Information:
Layout table for additonal information
Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT04665752    
Other Study ID Numbers: 10000078
000078-EI
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: November 16, 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Images
Natural History
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases