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CompletedNCT04374656Updated May 31, 2024

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

An observational study in Conjunctivitis, SARS-CoV-2 and COVID-19, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-31.

Sponsored by Johns Hopkins University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Conjunctivitis
  • SARS-CoV-2
  • COVID-19
  • Ocular Infection, Viral
  • Ocular Inflammation

Keywords

  • conjunctivitis
  • SARS-CoV-2
  • COVID-19
  • Ocular Infection
  • viral conjunctivitis
  • ocular inflammation
  • conjunctival swab
  • PCR
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Adults lacking capacity to consent
  • Adults with special needs due to physical, medical, developmental or cognitive conditions
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

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

    Number of conjunctival samples with positive PCR divided by the total number of conjunctival samples

    Time frame: 1 year

Secondary outcomes

  1. Proportion of nasal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples

    Number of nasal samples with positive PCR divided by the number of conjunctival samples with positive PCR

    Time frame: 1 year

  2. Proportion of nasopharyngeal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples

    Number of nasopharyngeal samples with positive PCR divided by the number of conjunctival samples with positive PCR

    Time frame: 1 year

  3. Rate of development of COVID-19 in the study patient population

    Number of patients developed COVID-19 divided by the number of the study population

    Time frame: 1 year

  4. Positive conjunctival sample rate in patient developed COVID-19

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

    Time frame: 1 year

06

Study locations

1 site
  • Wilmer Eye Institute
    Baltimore, Maryland 21287, United States
07

Registry details

Key details

Study ID
NCT04374656
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
May 5, 2020
Start date
May 18, 2020
Primary completion
May 29, 2024
Completion
May 29, 2024
Last update
May 31, 2024

Study contacts

Sezen Karakus, MD
principal investigator · Wilmer Eye Institute at Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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