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临床试验/NCT04799704
NCT04799704终止不适用

Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
1
主要终点
The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.

研究概览

简要总结

To investigate the presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients.

详细描述

The end goal of the study is to show whether or not the virus can be found in the tear film in both symptomatic and less symptomatic patients by means of serial sampling.

A sample of the tears / conjunctiva will be taken with a soft brush (similar to a cotton swab) every three days until the end of the hospitalization. In addition, you must complete a questionnaire that assesses the symptoms present.

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

  • Subject needs to be above 18 years old.
  • The subject is willing to undergo sampling of the conjunctiva.
  • The subject is willing to fill in a questionnaire.
  • The subject is fluent in written and verbal Dutch.
  • The subject is capable of giving informed consent.
  • Applicable for part 1 only: the subject test positive for SARS-nCoV-2 on a nasopharyngeal swab. The time window between a positive nasopharyngeal swab and the first conjunctival swab may be no more than 3 days.

排除标准

  • Allergy to Oxybuprocainehydrochloride
  • Pregnancy or lactation

结局指标

主要结局

The Presence of SARS-nCoV-2 in the Tear Film of Symptomatic and Pauci-symptomatic SARS-nCoV-2 Positive Patients.

时间窗: during hospitalization every 3 days until the day of discharge up to 1 month

Bilateral conjunctival sampling will be performed on both eyes after the application of a drop of topical anesthesia at least once.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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