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临床试验/NCT04840966
NCT04840966已完成不适用

Simplified Flavor Test for Self-administation in COVID-19 Positive Patients

Federico II University1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2020年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
111
试验地点
1
主要终点
Flavor perception

研究概览

简要总结

The Flavor test has been developed and validated by our group to assess retro-nasal olfactory performances.

The original flavor test has been simplified, with the great advantage to be self-administrable for COVID-19 patients in isolation, without any risk to health professionals.

详细描述

Smell and taste dysfunctions (STDs) are symptoms associated with COVID-19 syndrome, even if their incidence is still uncertain and variable. In this study, the effects of SARS-CoV-2 infection on chemosensory function have been investigated using both a self-reporting questionnaire on smell and flavor perception, and a simplified flavor test. A total of 111 subjects (19 hospitalized [HOS] and 37 home-isolated [HI] COVID-19 patients, and 55 healthy controls [CTRL]) were enrolled in the study. The flavor test used consists in the self-administration of four solution with a pure olfactory stimulus (coffee), a mixed olfactory-trigeminal stimulus (peppermint), and a complex chemical mixture (banana).

After SARS-CoV-2 infection, HOS and HI patients reported similar frequency of STDs, with a significant reduction of both smell and flavor self-estimated perception.

The aromas of the Flavor test were recognized by HI and HOS COVID-19 patients similarly to CTRL, however the intensity of the perceived aromas was significantly lower in patients compared to controls.

This suggests that a chemosensory impairment is present after SARS-CoV-2 infection, and the modified "flavor test" could be a novel self-administering objective screening test to assess STDs in COVID-19 patients.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Adults (≥18 years of age) that gave their written informed consent to the study
  • Diagnosis of COVID-19 was confirmed by PCR of nasopharyngeal swab (HI or HOS)
  • Negative COVID-19 nasopharyngeal swab (CTRL)
  • Subjects with no critical conditions and able to understand the protocol

排除标准

  • nasal obstruction or previous nasal diseases

结局指标

主要结局

Flavor perception

时间窗: Apr, 2020- Jan, 2021

To assess qualitative flavor perception

次要结局

  • Flavor perception intensity(Apr, 2020- Jan, 2021)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paolo Emidio Macchia

Md., Ph.D.

Federico II University

研究点 (1)

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