Corona Virus Infection, COVID, COVID-19, SARS-CoV-2
Conditions
Keywords
COVID-19, SARS-CoV-2, Tear, Nasopharyngeal Swab
Brief summary
Purpose: * To determine the presence of SARS-CoV-2 in tears * To determine SARS-CoV-2 receptors in tear production system
Detailed description
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.
Interventions
DIAGNOSTIC_TESTTear Collection
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.
Sponsors
University of Minnesota
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Virus Detection in Tears | At day 1 of study participation | Outcome is reported as the percent of tear samples that test either positive, negative, or indeterminant for SARS-CoV-2 Virus presence. |
| COVID-19 Virus Detection in Nasopharyngeal Swabs | At day 1 of study participation | Outcome is reported as the percent of nasopharyngeal swab samples that test either positive, negative, or indeterminant for SARS-CoV-2 Virus presence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expression of ACE2 in Lacrimal Gland Samples | At day 1 of study participation | 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). |
| Expression of ACE2 in Ocular Surface Samples | At day 1 of study participation | 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). |
Countries
United States
Outcome results
None listed