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NCT04374656 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04374656
Other study ID # IRB00249598
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 18, 2020
Est. completion date May 2024

Study information
Verified date June 2023
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Wilmer Eye Institute Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 1 year
Secondary 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 1 year
Secondary 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 1 year
Secondary 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 1 year
Secondary 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 1 year
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