Detecting SARS-CoV-2 in Tears

• ClinicalTrials.gov Identifier: NCT04526769
• Recruitment Status: Not yet recruiting
• First Posted: August 26, 2020
• Last Update Posted: February 3, 2022
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

Brief Summary:

Purpose:

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

Condition or disease	Intervention/treatment
COVID; COVID-19; Corona Virus Infection; SARS-CoV-2	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 Design

• Study Type: Observational
• Estimated Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Detecting SARS-CoV-2 Virus in Tears From Patients With COVID-19
• Estimated Study Start Date: September 2022
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. COVID-19 Virus Detection in Tears [ Time Frame: 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.
2. COVID-19 Virus Detection in Nasopharyngeal Swabs [ Time Frame: 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 :

1. Expression of ACE2 in Lacrimal Gland Samples [ Time Frame: 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).
2. Expression of ACE2 in Ocular Surface Samples [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: Hossein Nazari, MD; 612-626-2056; nazari@umn.edu

Contact: Corey Miller; mill8612@umn.edu

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Contact: Hossein Nazari, MD nazari@umn.edu

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Hossein Nazari, MD; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04526769
• Other Study ID Numbers: OVNS-2020-29066
• First Posted: August 26, 2020
• Last Update Posted: February 3, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota:

COVID-19; SARS-CoV-2; Tear; Nasopharyngeal Swab

Additional relevant MeSH terms:

COVID-19; Coronavirus Infections; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases