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

Completed

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

• Registration Number: NCT04374656
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-05
• Study Start: 2020-05-18
• Status Verified: 2024-05
• Primary Completion: 2024-05-29
• Study Completion: 2024-05-29
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Wilmer Eye Institute; 🇺🇸 Baltimore, Maryland, United States