Detecting SARS-CoV-2 in Tears
- Conditions
- COVIDSARS-CoV-2COVID-19Corona Virus Infection
- Interventions
- Diagnostic Test: Tear Collection
- Registration Number
- NCT04526769
- Lead Sponsor
- University of Minnesota
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- Patients presenting at study sites with confirmed or suspected COVID-19
- Pregnancy or nursing
- non-English speakers
- Those unable to read
- Those in other vulnerable study populations
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 Patients Tear Collection 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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).
Trial Locations
- Locations (1)
University of Minnesota
πΊπΈMinneapolis, Minnesota, United States