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Completed

NCT Number: NCT04526769

Detecting SARS-CoV-2 in Tears

Purpose:

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

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Key information

Conditions

COVID COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Infections Lacerations Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Virus Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tear Collection

Diagnostic Test

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2020
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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