跳至主要内容
临床试验/NCT04603794
NCT04603794Unknown4 期

Comparison of Normal Saline, Hydrogen Peroxide, Chlorhexidine and Povidone-Iodine Mouth Rinses in COVID-19 Patients

Ohio State University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10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
入组人数
60
试验地点
1
主要终点
ct values

研究概览

简要总结

Researchers know that the virus that causes COVID-19 has been found in the saliva (spit) of individuals who exhibit signs of the disease. Investigators would like to test the ability of three mouthwashes to reduce the levels of this virus in participants' mouths. Investigators will ask participants to use a liquid to swish around in the mouth for 30 seconds and spit it into a collection cup. Investigators will also collect spit from participants before and after participants use the mouthwash. Although participants will have no direct benefits from the study, investigators will gain a wealth of information that would benefit patients who are at risk for COVID-19.

详细描述

Project aims:

Aim 1: To examine the salivary carriage of COVID-19 in individuals before and after use of mouthwashes known to reduce oral microbiota, using real time reverse transcriptase quantitative PCR (Polymerase Chain Reaction) to quantify viral load.

RESEARCH STRATEGY:

A. Recruitment and baseline data:

This is a cross-sectional interventional 4 arm study. 60 subjects between 18-80 years of age will be recruited from those who are being treated for COVID-19 at the Ohio State University Medical Center. There is no data upon which to base sample size estimates, and investigators have landed on this number in an effort to obtain a representative sample of Ohio's population. If the potential subject is interested in participating, the study coordinator will collect contact information from the candidate and the consent form will be presented to these individuals. Subjects will be allowed sufficient time to read and ask questions, and once sign these forms, a detailed history including information about ethnicity, education, income, age, sex, race, medical status (including pregnancy) and dental history will be elicited. Subjects will self-collect saliva in a 5 ml collection tube, following which they will be asked to use one of 3 mouthwashes (chlorhexidine, povidone iodine, hydrogen peroxide or control(saline) for thirty seconds and spit them into collection tubes. Investigators will use Peridex, Hydrogen Peroxide and Betadine, which are commercially available formulations of chlorhexidine, hydrogen peroxide and betadine respectively, to reduce formulation bias. Investigators have attached the product labels as appendices to this proposal. The exact mouthwash will be decided by random chance using a random number generator. Investigators have generated the following randomization schedule using Microsoft excel: Each subject will be assigned a number as they are recruited (E.g. first patient to sign the consent will be patient 1, and the second will be patient 2 and so on). Patients 1 and 2 will receive saline and 3 will receive chlorhexidine etc. base on the above randomization schedule. Subjects will then collect saliva in separate collection tubes 15 and 30 minutes after rinsing.

研究设计

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

盲法说明

Double Blinded. All mouthwash vials are masked.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults age 18-80 admitted to The Ohio State University Medical Center,
  • diagnosis of COVID-19 confirmed by Polymerase Chain Reaction (PCR),
  • salivary carriage of COVID-19 virus
  • ability to perform mouthwash rinses and to expectorate.

排除标准

  • allergy to any study mouth rinse,
  • active uncontrolled thyroid disease,
  • patients undergoing radioactive iodine therapy.

研究组 & 干预措施

0.12% Chlorhexidine Gluconate Mouth Rinse

Active Comparator

30 second oral rinse with 0.12% Chlorhexidine Gluconate

干预措施: 0.12% Chlorhexidine Gluconate Mouth Rinse (Drug)

0.9% Normal Saline Mouth Rinse

Placebo Comparator

30 second oral rinse with 0.9% Normal Saline

干预措施: 0.9% Normal Saline (Drug)

1% Hydrogen Peroxide Mouth Rinse

Active Comparator

30 second oral rinse with 1% Hydrogen Peroxide

干预措施: 1% Hydrogen Peroxide (Drug)

0.5% Povidone Iodine Mouth Rinse

Active Comparator

30 second oral rinse with 0.5% Povidone Iodine Mouth wash

干预措施: 0.5% Povidone Iodine (Drug)

结局指标

主要结局

ct values

时间窗: 3 measurements of changes from times 0 minutes.vs:15 minutes, and vs:45 minutes during a single session

cycle thresholds

real time reverse transcriptase quantitative PCR

时间窗: 3 measurements of changes from times 0 minutes. vs:15 minutes, and vs: 45 minutes during a single session

Saliva load was expressed in copies x 10 8 of COVID-19 RNA

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

David Hall

Associate Professor, Hospital Attending

Ohio State University

研究点 (1)

Loading locations...

相似试验

Efficacy of Mouthwash in Reducing Salivary Carriage... | 临床试验