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临床试验/NCT04526769
NCT04526769已完成不适用

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

University of Minnesota1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
COVID-19 Virus Detection in Tears

研究概览

简要总结

Purpose:

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

COVID-19 Virus Detection in Tears

时间窗: 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.

COVID-19 Virus Detection in Nasopharyngeal Swabs

时间窗: 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.

次要结局

  • Expression of ACE2 in Ocular Surface Samples(At day 1 of study participation)
  • Expression of ACE2 in Lacrimal Gland Samples(At day 1 of study participation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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