Detecting SARS-CoV-2 in Tears

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

Purpose:

• To determine the presence of SARS-CoV-2 in tears
• To determine SARS-CoV-2 receptors in tear production system

Study Overview

• Status: Completed
• Conditions: COVID-19; COVID; Corona Virus Infection; SARS-CoV-2
• Intervention / Treatment: Diagnostic test: Tear Collection

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.

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients meeting inclusion criteria who are willing to participate will be included until the total number of 30 participants is reached.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

COVID-19 Patients; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Hossein Nazari, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ACTUAL): December 30, 2021
• Study Completion (ACTUAL): December 30, 2021

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (ACTUAL): August 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Tear; Nasopharyngeal Swab
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: OVNS-2020-29066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No