Detecting SARS-CoV-2 in Tears

Study Overview
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Brief Summary
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Purpose: To determine the presence of SARS-CoV-2 in tears To determine SARS-CoV-2 receptors in tear production system

Detailed Description
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This is a prospective case series. NP swab and tear samples will be collected simultaneously from the confirmed or suspected COVID-19 patients. The samples will be transferred to the lab for SARS-CoV-2 testing. The presence of absence of SARS-CoV-2 will be compared in tears versus NP swabs. The second part of the study is a histopathology examination series. Normal lacrimal gland and ocular surface tissue samples already stored at the UMN ocular pathology lab and Lion's Gift of Sight Eye Bank will be used for IHC staining for ACE2 and similar targets.

Official Title
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Detecting SARS-CoV-2 Virus in Tears From Patients With COVID-19

Conditions
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COVID, COVID-19, Corona Virus Infection, SARS-CoV-2

Intervention / Treatment
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* Diagnostic Test: Tear Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients presenting at study sites with confirmed or suspected COVID-19 Exclusion Criteria: Pregnancy or nursing non-English speakers Those unable to read Those in other vulnerable study populations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Patients<br>All patients aged 18 years and above who present to Fairview/UMN ERs or ICUs with confirmed or suspect COVID-19 based on the attending physician's judgment will be included. | Diagnostic Test: Tear Collection<br>* A microcapillary tube will be placed at the corner of the eyelid so tears can be absorbed to the tube without causing any trauma. The tube will be placed in a transfer tube. Standard virus sampling swabs will be used to collect samples from the same patient's nasopharynx. RT-PCR will be run to determine virus yield in each sample. For the second part of the study, IHC staining will be done on the existing ocular tissue pathology slides to detect the expression of ACE2 and other cell surface and intracellular receptors. The investigators will use existing UMN ocular pathology lab and Lion's Eye Bank tissue samples. These are banked tissue samples that were collected and examined previously and then the remaining tissue samples were stored.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Virus Detection in Tears | Outcome is reported as the percent of tear samples that test either positive, negative, or indeterminant for SARS-CoV-2 Virus presence. | At day 1 of study participation | 
| COVID-19 Virus Detection in Nasopharyngeal Swabs | Outcome is reported as the percent of nasopharyngeal swab samples that test either positive, negative, or indeterminant for SARS-CoV-2 Virus presence. | At day 1 of study participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of ACE2 in Lacrimal Gland Samples | Pathology slides of lacrimal gland samples will be assessed for ACE2 expression and rated as having no expression (score=1), mild expression (score=2), or heavy expression (score=3). Outcome reported as the percent of lacrimal gland samples scored in each category (no expression, mild expression, or heavy expression). | At day 1 of study participation | 
| Expression of ACE2 in Ocular Surface Samples | Pathology slides of ocular surface samples will be assessed for ACE2 expression and rated as having no expression (score=1), mild expression (score=2), or heavy expression (score=3). Outcome reported as the percent of ocular surface samples scored in each category (no expression, mild expression, or heavy expression). | At day 1 of study participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, Tear, Nasopharyngeal Swab