Detecting SARS-CoV-2 in Tears

NCT04526769 | Completed

• 1 other identifier: OVNS-2020-29066
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose:

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

Conditions

COVID; COVID-19; Corona Virus Infection; SARS-CoV-2

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Expression of ACE2 in Lacrimal Gland Samples

  At day 1 of study participation

• Expression of ACE2 in Ocular Surface Samples

  At day 1 of study participation

Study Arms (1)

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

Interventions

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.

COVID-19 Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Patients presenting at study sites with confirmed or suspected COVID-19

You may not qualify if:

• Pregnancy or nursing
• non-English speakers
• Those unable to read
• Those in other vulnerable study populations

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Lacerations

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries

Study Officials

• Hossein Nazari, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 26, 2020
• Study Start: September 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

US (1)