Clincosm LogoSign in Get a demo

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

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04374656
Collaborator
(none)
100
Enrollment
1
Location
35.4
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 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
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of conjunctival samples tested positive for SARS-CoV-2 [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 [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 [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 [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 [1 year]

      Number of conjunctival samples with positive PCR divided by the number of patients developed COVID-19

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wilmer Eye Institute Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT04374656
    Other Study ID Numbers:
    • IRB00249598
    First Posted:
    May 5, 2020
    Last Update Posted:
    May 16, 2022
    Last Verified:
    May 1, 2022
    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:
    COVID-19
    Eye Infections
    Virus Diseases
    Eye Infections, Viral
    Conjunctivitis
    Inflammation

    Study Results

    No Results Posted as of May 16, 2022