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临床试验/NCT05214196
NCT05214196已完成4 期

The Effectiveness of Oral Antiseptics on the Intraoral Viral Load of SARS-CoV-2

Ataturk University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
75
试验地点
1
主要终点
RT-PCR analysis

研究概览

简要总结

In a study conducted on 75 COVID-19 patients, the effect of SARS-CoV-2 on viral load was investigated as a result of the use of hypochlorous acid and povidone-iodine as an oral antiseptic.

详细描述

Before and 30 minutes after rinsing with mouth antiseptics, the participants were asked to rinse the mouth and throat for 30 seconds with 0.9% isotonic saline. The sample was sputtered into a sterile plastic container. The participants were grouped according to the type of oral antiseptics used. The effectiveness of SARS-CoV-2 viral load was investigated by rinsing the mouth and throat for 30 seconds with 20 ml of hypochlorous acid, povidone-iodine, and isotonic saline. Viral load was analyzed by RT-PCR analysis. The results were evaluated by statistical analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

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

  • Positive SARS-CoV-2 RT-PCR result,
  • Adult hospitalized patient,
  • The participants have the physical and psychological ability to follow the instructions in the study.

排除标准

  • Patients intubated and supported by a mechanical respirator,
  • Severe acute or chronic medical or psychiatric condition,
  • History of significant adverse effects following use of oral hygiene products such as toothpaste and mouth rinses,
  • Active uncontrolled thyroid disease,
  • Developmental/cognitive disability,
  • Pregnancy,
  • Undergoing radioactive iodine therapy.

研究组 & 干预措施

Hypochlorous acid group

Experimental

The effect of 0.02% Hypochlorous acid solution on viral load was investigated by using 25 COVID-19 patients as an oral antiseptic for 30 seconds.

干预措施: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO) (Drug)

Povidone-iodine group

Active Comparator

The effect on viral load was investigated by using 0.5% Povidone-iodine solution as an oral antiseptic for 30 seconds in 25 COVID-19 patients.

干预措施: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO) (Drug)

Saline group

Placebo Comparator

The effect on viral load was investigated by using 0.9% isotonic saline solution as a placebo for 30 seconds in 25 COVID-19 patients.

干预措施: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO) (Drug)

结局指标

主要结局

RT-PCR analysis

时间窗: two weeks

For the quantitative analysis of the amount of SARS-CoV-2 RNA in the obtained samples, the Real-time Reverse Transcyptase Polymerase Chain Reaction method was used.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sema Nur Sevinc

Assistant Professor

Ataturk University

研究点 (1)

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