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

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: NCT04374656
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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.

Condition or disease
Conjunctivitis SARS-CoV-2 COVID-19 Ocular Infection, Viral Ocular Inflammation

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients Presenting With Conjunctivitis to the Ophthalmology Clinics During the COVID-19 Pandemic
Actual Study Start Date : May 18, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Biospecimen Retention:   Samples With DNA
Conjunctival, nasal, and nasopharyngeal swabs will be taken for PCR testing. Tear samples will be collected to detect certain inflammatory markers and specific proteins.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

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): NCT04374656


Contacts
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Contact: Sezen Karakus, MD 410-955-5080 skarakus@jhmi.edu

Locations
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United States, Maryland
Wilmer Eye Institute Recruiting
Baltimore, Maryland, United States, 21287
Contact: Sezen Karakus, MD       skarakus@jhmi.edu   
Principal Investigator: Sezen Karakus, MD         
Sub-Investigator: Ashley Behrens, MD         
Sub-Investigator: Elia Duh, MD         
Sub-Investigator: Charles Eberhart, MD PhD         
Sub-Investigator: James Foster, PhD         
Sub-Investigator: Uri Soiberman, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Sezen Karakus, MD Wilmer Eye Institute at Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04374656    
Other Study ID Numbers: IRB00249598
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
conjunctivitis
SARS-CoV-2
COVID-19
Ocular Infection
viral conjunctivitis
ocular inflammation
conjunctival swab
PCR
Additional relevant MeSH terms:
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Eye Infections
Virus Diseases
Eye Infections, Viral
Conjunctivitis
Inflammation
Infection
Pathologic Processes
Conjunctival Diseases
Eye Diseases