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临床试验/NCT05950295
NCT05950295已完成不适用

Intranasal Lavage With Hypochlorous Acid Safely Reduces the Symptoms in the Ambulatory Patient With COVID-19.

Monique Lisa Abner1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2020年9月24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
88
试验地点
1
主要终点
Reduction in symptoms of COVID-19

研究概览

简要总结

The goal of this observational study is to determine if intranasal lavage reduces symptoms in adults with COVID-19. The main question is can a hypochlorous acid solution reduce the symptoms of COVID-19.

Participants will asked to do the following:

  • Irrigate each nostril once a day for ten days with a hypochlorous acid solution.
  • Write a daily record of the presence or absence of symptoms such as fever, headache, chills, nausea, or change in sense of smell.
  • After ten days, return the daily log in the mail to the investigator.

详细描述

Methods This study was approved by the Institutional Review Board of Reading Hospital (IRB 036-020) with informed consent obtained from all adult participants. Convenience sampling methodology was utilized for those who met the study criteria inclusive to all gender at ages18 years old and/or older. Excluded participants were those who expressed the desire to not use nasal lavage, women with known pregnancies, and children aged 17 years old and/or younger. The source of enrollees was generated from patients presenting to an ambulatory testing facility for nasopharyngeal swabs for COVID-19. Swab analysis was obtained by reverse transcription-polymerase chain reaction until the COVID-19 antigen specific test (Binax NOW, Abbott Lab) became available for use which allowed a more lenient process for including the Covid-19 positive patients. Each enrolled participant was given a Nasaflo Neti Pot (NeilMed Pharmaceuticals, Inc) with instructions to irrigate each nostril once a day for ten days with the provided hypochlorous solution Vashe Wound Solution (Urgo Medical North America, LLC). Each participant began the daily 120 cc (four -ounce) nasal lavage intervention within 72 hours of their testing. Each participant was given a scripted diary log in which they recorded daily the presence or absence of clinical symptoms such as elevated temperature, fatigue, headache, chills, nausea, and anosmia by noting "yes" or "no." After completing the ten days of nasal lavage, each log was returned to the principal investigator via mail. The participants remained quarantined for the recommended time period of 14 days, and adhered to social distancing, handwashing, and donning of face masks. Throughout the study, each participant was urged to not share their devices with any other individuals. After thirty days from the start of their nasal intervention, participants were telephoned for a follow-up review.

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

  • All gender aged 18 years and older.
  • Positive COVID-19 specific antigen test resulted within 72 hours.

排除标准

  • Persons with known current pregnancy
  • Persons less than or equal to 17 years of age.
  • Persons currently using any intranasal medications or agents
  • Persons unwilling to use nasal lavage.

结局指标

主要结局

Reduction in symptoms of COVID-19

时间窗: 40 days from start of nasal lavage

Change in sense of smell, fever profile, nasal congestion, and headache

次要结局

未报告次要终点

研究者

发起方
Monique Lisa Abner
申办方类型
Other
责任方
Sponsor

研究点 (1)

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