Covid19, Eye Diseases
Conditions
Brief summary
To investigate the presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients.
Detailed description
The end goal of the study is to show whether or not the virus can be found in the tear film in both symptomatic and less symptomatic patients by means of serial sampling. A sample of the tears / conjunctiva will be taken with a soft brush (similar to a cotton swab) every three days until the end of the hospitalization. In addition, you must complete a questionnaire that assesses the symptoms present.
Interventions
DIAGNOSTIC_TESTswabbing of conjunctiva
Each eye will be sampled with a single, sterile, nylon, flocked swab
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject needs to be above 18 years old. * The subject is willing to undergo sampling of the conjunctiva. * The subject is willing to fill in a questionnaire. * The subject is fluent in written and verbal Dutch. * The subject is capable of giving informed consent. * Applicable for part 1 only: the subject test positive for SARS-nCoV-2 on a nasopharyngeal swab. The time window between a positive nasopharyngeal swab and the first conjunctival swab may be no more than 3 days.
Exclusion criteria
* Allergy to Oxybuprocainehydrochloride * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients. | during hospitalization every 3 days until the day of discharge up to 1 month | Bilateral conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia at least once. |
Countries
Belgium
Participant flow
Recruitment details
Conjunctival sampling will take place every three days until the day of hospital discharge.
Participants by arm
| Arm | Count |
|---|---|
| Symptomatic Patient The first part of our study is to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients.
swabbing of conjunctiva: Each eye will be sampled with a single, sterile, nylon, flocked swab | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Symptomatic Patient | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 6 Participants | — |
| Age, Categorical Between 18 and 65 years | 24 Participants | — |
| Age, Continuous | 65 years STANDARD_DEVIATION 16 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 30 participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.
Bilateral conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia at least once.
Time frame: during hospitalization every 3 days until the day of discharge up to 1 month
Population: symptomatic patients admitted at our University Hospital Leuven, Belgium with a positive nasopharyngeal swab for SARS-nCoV-2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Symptomatic Patient | The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients. | positive SARS-CoV-2 swab | 13 swabs |
| Symptomatic Patient | The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients. | strongly positive SARS-CoV-2 | 3 swabs |
| Symptomatic Patient | The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients. | weakly positive SARS-CoV-2 | 10 swabs |