Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients With Conjunctivitis During the COVID-19 Pandemic

May 30, 2024 updated by: Johns Hopkins University

Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients Presenting With Conjunctivitis to the Ophthalmology Clinics During the COVID-19 Pandemic

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly identified, highly contagious RNA virus causing respiratory infectious disease, Coronavirus Disease 2019 (COVID-19). Conjunctivitis has been reported as a rare finding of the disease, and preliminary studies showed that the virus RNA could be detected in ocular secretions using polymerase chain reaction (PCR) assays when conjunctivitis present. This study aims to estimate the proportion of SARS-CoV-2 associated conjunctivitis among patients with suspected viral conjunctivitis presented to the ophthalmology clinics of Wilmer Eye Institute during the COVID-19 pandemic. The investigators also aim to identify whether SARS-CoV-2 associated conjunctivitis is an isolated finding or an early sign of COVID-19.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Wilmer Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients present or are referred to the ophthalmology clinic due to red eye complaints, suspected viral conjunctivitis, or keratoconjunctivitis will be consecutively approached and recruited if they show a willingness to participate.

Description

Inclusion Criteria:

  • Age 18 years old or older
  • Willingness to participate
  • Presents with red eye complaint

Exclusion Criteria:

  • Adults lacking capacity to consent
  • Adults with special needs due to physical, medical, developmental or cognitive conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of conjunctival samples tested positive for SARS-CoV-2
Time Frame: 1 year
Number of conjunctival samples with positive PCR divided by the total number of conjunctival samples
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of nasal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples
Time Frame: 1 year
Number of nasal samples with positive PCR divided by the number of conjunctival samples with positive PCR
1 year
Proportion of nasopharyngeal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples
Time Frame: 1 year
Number of nasopharyngeal samples with positive PCR divided by the number of conjunctival samples with positive PCR
1 year
Rate of development of COVID-19 in the study patient population
Time Frame: 1 year
Number of patients developed COVID-19 divided by the number of the study population
1 year
Positive conjunctival sample rate in patient developed COVID-19
Time Frame: 1 year
Number of conjunctival samples with positive PCR divided by the number of patients developed COVID-19
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Sezen Karakus, MD, Wilmer Eye Institute at Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2020

Primary Completion (Actual)

May 29, 2024

Study Completion (Actual)

May 29, 2024

Study Registration Dates

First Submitted

May 1, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00249598

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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