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Detecting SARS-CoV-2 in Tears

Completed
Conditions
COVID
SARS-CoV-2
COVID-19
Corona 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
Inclusion Criteria
  • Patients presenting at study sites with confirmed or suspected COVID-19
Read More
Exclusion Criteria
  • Pregnancy or nursing
  • non-English speakers
  • Those unable to read
  • Those in other vulnerable study populations
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
COVID-19 PatientsTear CollectionAll 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
NameTimeMethod
COVID-19 Virus Detection in TearsAt 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 SwabsAt 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
NameTimeMethod
Expression of ACE2 in Ocular Surface SamplesAt 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 SamplesAt 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

πŸ‡ΊπŸ‡Έ

Minneapolis, Minnesota, United States

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