Double-blind, Randomized, Parallel, Placebo-controlled Clinical Study to Evaluate the Viral Load of SARS-CoV-2 in the Oral Cavity of SARS-CoV-2 Positive Subjects After the Use of a Mouthwash Containing Cetylpyridinium Chloride 0,07%
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Dentaid SL
- 入组人数
- 118
- 试验地点
- 19
- 主要终点
- SARS-CoV-2 viral load in saliva samples measured by RT-qPCR
研究概览
简要总结
Double-blind, parallel, randomized, placebo-controlled clinical study. Subjects with confirmed SARS-CoV-2 infection by PCR or antigen rapid test, asymptomatic or with mild COVID-19 symptoms will be included. Subjects who agree to participate and who are eligible will be randomized to perform a mouth rinse and gargle with a 0.07% CPC mouthwash (experimental) or with a substance of the same color (placebo). Saliva samples will be collected at baseline (i.e., before wash) and 1 hour and 3 hours after wash. Saliva samples will be transferred to a central laboratory for SARS-CoV-2 viral load determination, nucleocapsid protein levels determination, rapid antigen testing, viral infectivity analysis and storage.
详细描述
Study procedures will be as follows:
The study procedures will take place in 1 day (total interval of 3 hours from the baseline sample collection to the last sample collection).
The study samples will be saliva samples (1-1.5 ml) collected at baseline and 1 and 3 hours after the intervention. The intervention will be the use of a mouthwash (washes and gargles) for one minute with 15 ml of either CPC Protect® (CPC group) or colored distilled water (control group).
Candidates with a positive result of PCR or antigen rapid test for SARS-CoV-2 will be identified by study nurses, certified nursing assistants, and dentists at primary health care centers of the Metro Nord health administrative region of Catalonia. The investigator will obtain the candidates' informed consent and will verify that the subject meets all the inclusion criteria and none of the exclusion criteria. The researcher will assign a correlative kit number (randomization) and instruct the subject in the procedure of self-collection of a saliva sample.
Baseline: The subject will self-collect the baseline saliva sample in front of the investigator, who will be able to correct the errors observed in the procedure.
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
- Double (Participant, 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
- 否
入选标准
- •Age equal to or greater than 18 years
- •Confirmation of SARS-CoV-2 infection, determined by PCR or validated rapid antigen test1 from a nasopharyngeal smear performed in ≤3 days.
- •Without symptoms of COVID-19 or with symptoms with ≤3 days of evolution
- •Cognitive and motor ability to perform mouthwashes and gargles
- •Willingness to comply with the requirements of the protocol
- •Understanding of the information provided in relation to the objectives and procedures
- •Provide your consent freely to participate in the study.
排除标准
- •Use of mouthwashes, in the last 24 hours
- •Use of VITIS pastes and / or PERIO AID gel, in the last 24 hours
- •Four or more days of symptoms compatible with COVID-
- •Recent medical diagnosis (≤ 1 month) of pneumonia
- •Cognitive impairment or other reason that, in the investigator's discretion, contraindicates participation in the study
研究组 & 干预措施
0.07% cetylpyridinium chloride (CPC) in mouthwash
Single dose. A mouthwash and gargles with 15 ml of product for 1 minute.
干预措施: 0.07% cetylpyridinium chloride (CPC) in mouthwash (Other)
Distilled water with the same colorant as the experimental product
Single dose. A mouthwash and gargles with 15 ml of product for 1 minute.
干预措施: Distilled water with the same colorant as the experimental product (Other)
结局指标
主要结局
SARS-CoV-2 viral load in saliva samples measured by RT-qPCR
时间窗: 1 hour and 3 hours after intervention
To determine the efficacy of a 0.07% CPC mouthwash in reducing the viral load of SARS-CoV-2 in saliva samples, measured by RT-qPCR, in subjects with confirmed SARS-CoV-2 infection
Nucleocapsid protein levels in saliva samples measured by ELISA
时间窗: 1 hour and 3 hours after intervention
To determine the efficacy of a 0.07% CPC mouthwash in increasing the nucleocapsid protein levels in saliva samples, measured by high-sensitivity quantitative ELISA (ImmunoDiagnostics), in subjects with confirmed SARS-CoV-2 infection
次要结局
- SARS-CoV-2 viral load in saliva samples determined by RT-qPCR(3 hours after intervention)
- Sensitivity and specificity of different rapid SARS-CoV-2 antigen tests compared to RT-qPCR in saliva samples(1 hour and 3 hours after intervention)
- Intraindividual difference in SARS-CoV-2 infectivity in vitro before and after treatment with a 0.07% CPC or placebo(Baseline, 1 hour and 3 hours after intervention)
- SARS-CoV-2 viral load in saliva samples determined by RT-qPCR(1 hour after intervention)