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临床试验/NCT05458336
NCT05458336已完成不适用

Saline Nasal Irrigations to Eradicate SARS-CoV-2

University of Padova2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2022年3月8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
107
试验地点
2
主要终点
Symptoms' course

研究概览

简要总结

Consecutive adult (>18 years old) subjects who tested positive for SARS-CoV-2 with nasopharyngeal swab at the local COVID-19 Prevention Centre were included.

Patients were divided into two groups: cases (who performed nasal lavages) and controls (who did not perform lavages), with similar confounding factors (age, comorbidities, vaccination status).

At the moment of diagnosis, patients were asked to fill out an ad hoc questionnaire to evaluate their symptoms at the moment of diagnosis and of negativization.

Subjects were asked to perform, at a daily time of their choice, a nasal swab provided at the moment of enrolment. When the subjects tested negative for the first time, they had to complete the questionnaire once again.

The study was divided into two phases. In the first phase cases were recruited and were given nasal washes (Tonimer Panthexyl®) to be performed three times a day, and in any case after nasal swab. In the second phase controls were recruited and were asked to perform only daily nasal swabs.

Symptoms course and time of negativization were analyzed. Statistic comparisons were made using Kaplan-Meier test. P values <0,05 were considered to be statistically significant.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • age >18 years
  • starting participation to the study within the first 48 hours since diagnosis
  • ability in self-swabbing
  • ability in self-administration of nasal lavages

排除标准

  • age <18 years
  • refusal of participation
  • starting participation to the study after the first 48 hours since diagnosis
  • no ability in self-swabbing
  • no ability in self-administration of nasal lavages

结局指标

主要结局

Symptoms' course

时间窗: From date of the first positive swab until the date of to the first negative swab, up to 14 days

Evaluation of differences in disease's course between cases and controls by filling an ad hoc questionnaire about symptoms

次要结局

  • Time of negativization(From date of the first positive swab until the date of to the first negative swab, up to 14 days)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Sponsor

研究点 (2)

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