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OpenTrials
Completed

NCT Number: NCT04374656

Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients With Conjunctivitis 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.

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Key information

Conditions

Conjunctivitis COVID-19 Conjunctival Diseases Conjunctivitis, Viral Coronaviridae Infections Coronavirus Infections Eye Diseases Eye Infections Eye Infections, Viral Infections Lung Diseases Nidovirales Infections Ocular Infection, Viral Ocular Inflammation Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 5, 2020
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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