Effect of Oral Hygiene Products on Reducing Expelled/Exhaled SARS-CoV-2
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Control Phase - Primary Endpoint
研究概览
简要总结
Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling.
详细描述
The study will consist of a Control Phase to optimize procedures for measuring expelled/exhaled viral load, and a Evaluation phase comparing different commercially available mouthwashes.
In the Control Phase. up to 20 COVID-19 patients will be asked to undergo a sequence of face mask sampling and saliva collections prior to and after an oral rinse with (i) water and (ii) a commercially-available cetylpyridinium chloride (CPC) mouthwash.
Based on outcomes of the Control Phase, the study will proceed into the Evaluation Phase, which will randomize approximately 40 COVID-19 patients to receive 1 of 4 commercially available Colgate mouthwashes following standard package instructions. Face mask sampling and saliva will be collected prior to and after the mouth rinse to assess impact on SARS-CoV-2 viral load.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None (Participant, Outcomes Assessor)
盲法说明
Face mask and saliva SARS-CoV-2 viral RNA loads are measured before and after water rinse and before and after mouthwash rinse (intervention). Order is randomized. Participant is not told which rinse they are using, though can likely differentiate by taste.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide consent
- •Polymerase chain reaction (PCR)-confirmed SARS-CoV-2 within previous 48 hours.
排除标准
- •Clinical contraindication or poor feasibility to complete study procedures
- •Unwilling or unable to produce saliva or face mask samples
- •Unable to produce at least 500 microliters of saliva.
- •Eaten within past 30 minutes
- •Known allergy to mouthwash products
研究组 & 干预措施
0.075% Cetylpyridinium Chloride
Crossover design where a series of viral load measurements are taken before and after water rinse (placebo) and repeated before and after CPC rinse (intervention). The order of the rinses were randomized after the 19th participant.
干预措施: Mouthwash Product (Drug)
结局指标
主要结局
Control Phase - Primary Endpoint
时间窗: Single timepoint, ~1 hour
Reduction in viral load by face mask sampling from pre-intervention to 0-15 with CPC versus water rinse control
Evaluation Phase - Primary Endpoint
时间窗: Single timepoint, ~1.5 hours
Reduction in viral load by face mask sampling from pre-intervention to 45-60 minutes versus water rinse control
次要结局
- Evaluation Phase - Secondary Endpoint(Single timepoint, ~1 hour)
- Comparative Saliva Reduction(Single timepoint, ~1.5 hours)
研究者
Yingda L Xie
Assistant Professor
Rutgers, The State University of New Jersey