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insufficient positive samples
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To investigate the presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| symptomatic patient | to confirm the detectability of the SARS-nCoV-2 in the tear film of symptomatic patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| swabbing of conjunctiva | Diagnostic Test | Each eye will be sampled with a single, sterile, nylon, flocked swab |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during hospitalization every 3 days until the day of discharge up to 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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positive test for SARS-nCoV-2 on a nasopharyngeal swab.
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| Name | Affiliation | Role |
|---|---|---|
| Delbeke Heleen, MD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35367365 | Result | Leysen L, Delbeke H, Desmet S, Schauwvlieghe PP, Maes P, Blanckaert G, Matthys E, Joossens M, Casteels I. In search of viable SARS-CoV-2 in the tear film: a prospective clinical study in hospitalized symptomatic patients. Clin Microbiol Infect. 2022 Aug;28(8):1172-1173. doi: 10.1016/j.cmi.2022.03.026. Epub 2022 Mar 31. No abstract available. |
| Label | URL |
|---|---|
| In search of viable SARS-CoV-2 in the tear film: a prospective clinical study in hospitalized symptomatic patients. | View source |
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Conjunctival sampling will take place every three days until the day of hospital discharge.
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | symptomatic patients admitted at our University Hospital Leuven, Belgium with a positive nasopharyngeal swab for SARS-nCoV-2 | Posted | Number | swabs | during hospitalization every 3 days until the day of discharge up to 1 month | swabs | swabs |
|
Sampling will be repeated every 3 days to evaluate if PCR becomes positive during the course of disease and to monitor the duration of detectability of the virus in tears, up to 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heleen Delbeke, MD | UZ Leuven | 003216342229 | heleen.delbeke@uzleuven.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2020 | May 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| swabs |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |