ConjunctivitisNCT04374656
Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients With Conjunctivitis During the COVID-19 Pandemic
An observational study of Conjunctivitis and SARS-CoV-2, run by Johns Hopkins University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctivitis, SARS-CoV-2, COVID-19
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2020to 29 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 18 years old or older
- Willingness to participate
- Presents with red eye complaint
Who cannot join
- Adults lacking capacity to consent
- Adults with special needs due to physical, medical, developmental or cognitive conditions
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Keywords
- conjunctivitis, SARS-CoV-2, COVID-19, Ocular Infection, viral conjunctivitis, ocular inflammation, conjunctival swab, PCR
- Medical subject headings
- Conjunctivitis, COVID-19, Eye Infections, Viral, Eye Infections, Conjunctivitis, Viral
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (4)
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start18 May 2020
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConjunctivitisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sezen Karakus, MD, Principal investigator, Wilmer Eye Institute at Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374656
- Sponsor's protocol ID
- IRB00249598
- Status last verified
- May 2024
- First submitted
- 1 May 2020
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04374656
- Acronym / sponsor ID
- IRB00249598
- Keywords
- conjunctivitis, SARS-CoV-2, COVID-19, Ocular Infection, viral conjunctivitis, ocular inflammation, conjunctival swab, PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18 years old or older
- Willingness to participate
- Presents with red eye complaint
Key exclusion criteria (2 listed)
- Adults lacking capacity to consent
- Adults with special needs due to physical, medical, developmental or cognitive conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Proportion of nasal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples
Time frame: 1 year
Proportion of nasopharyngeal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples
Time frame: 1 year
Rate of development of COVID-19 in the study patient population
Time frame: 1 year
Positive conjunctival sample rate in patient developed COVID-19
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sezen Karakus, MD principal investigator
Wilmer Eye Institute at Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conjunctivitis and SARS-CoV-2, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of conjunctival samples tested positive for SARS-CoV-2 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.