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

NCT04374656 | Completed

• 1 other identifier: IRB00249598
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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

  1 year

Secondary Outcomes (4)

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

  1 year

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

  1 year

• Rate of development of COVID-19 in the study patient population

  1 year

• Positive conjunctival sample rate in patient developed COVID-19

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Conjunctival, nasal, and nasopharyngeal swabs will be taken for PCR testing and next-generation sequencing.

MeSH Terms

Conditions

Conjunctivitis; COVID-19; Eye Infections, Viral; Eye Infections; Conjunctivitis, Viral

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sezen Karakus, MD

  Wilmer Eye Institute at Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: May 18, 2020
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

US (1)