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NCT04526769 Clinical Trial

Detecting SARS-CoV-2 in Tears

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04526769
Other study ID # OVNS-2020-29066
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date December 30, 2021

Study information
Verified date October 2022
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 7
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
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