Efficacy of Three Antimicrobial Mouthwashes in Reducing SARS-CoV-2 Viral Load in the Saliva of Patients Diagnosed With COVID-19: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Viral load changes in the saliva within groups
研究概览
简要总结
This is a single-blind, parallel-group, randomized pilot study designed to evaluate and compare the efficacy of 3 different mouthwashes containing 0.2% Chlorhexidine digluconate, 1.5% Hydroxide peroxide or Cetylpyridinium chloride in reducing Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in the saliva of COVID-19 positive patients at different time-points.
A convenient sample of up to 40 COVID-19 positive patients diagnosed via test and/or presenting COVID-19 clinical symptoms will be identified in the inpatients and/or outpatient clinics at the Newham University Hospital and at The Royal London Hospital, Barts Health National Health Service (NHS) Trust, United Kingdom (UK).
The study will consist of one visit. Unstimulated saliva samples will be collected from all COVID-19 positive patients before and at 30 minutes, 1, 2, and 3 hours after mouth rinsing (Group 1-3 ) or no rinsing (Group 4). Viral load analysis of saliva samples in the different time-points will be then assessed by Reverse Transcription quantitative PCR (RT- qPCR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1 (test group; n= up to 10 patients) - 0.2 % Chlorhexidine digluconate
Participants will be instructed to rinse their mouth with 10 ml of Corsodyl® Alcohol free mouthwash for 1 minute.
干预措施: Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate (Drug)
Group 2 (test group; n= up to 10 patients) - 1.5% Hydrogen peroxide
Participants will be instructed to rinse their mouth with 10 ml of Colgate® Peroxyl mouthwash for 1 minute.
干预措施: Colgate Peroxyl® -1.5% Hydrogen peroxide (Drug)
Group 3 (test group; n= up to 10 patients) - Cetylpyridinium chloride
Participants will be instructed to rinse their mouth with 10 ml of Oral-B® Gum & Enamel Care mouthwashes for 1 minute.
干预措施: Oral-B® Gum & Enamel Care -Cetylpyridinium chloride (Other)
Group 4 (control group; n= up to 10 patients) - No rinsing
Patients will be instructed to not rinse their mouth with any solution, not even water.
干预措施: No rinsing (Other)
结局指标
主要结局
Viral load changes in the saliva within groups
时间窗: 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.
Viral load changes in the saliva of COVID-19 positive patients assessed by RT-qPCR assays at 30 minutes, 1, 2 and 3 hours after mouth rinsing with a mouthwash containing 0.2 % Chlorhexidine digluconate, 1.5% Hydroxide peroxide or Cetylpyridinium chloride compared to baseline.
次要结局
- Difference in the viral load changes in the saliva between groups(30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.)