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
| NCT number | NCT04374656 |
| Other study ID # | IRB00249598 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 18, 2020 |
| Est. completion date | May 29, 2024 |
| Verified date | May 2024 |
| Source | Johns Hopkins University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | May 29, 2024 |
| Est. primary completion date | May 29, 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Wilmer Eye Institute | Baltimore | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Johns Hopkins University |
United States,
| 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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