PILOT CLINICAL TRIAL TO ASSESS THE IMPACT OF ORAL INTERVENTION WITH CETIL PYRIDINIUM CHLORIDE TO REDUCE THE VIRAL LOAD OF SARS-CoV-2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples
研究概览
简要总结
Pilot, randomized and controlled clinical trial for the evaluation of the decrease in the viral load of SARS-CoV-2 in the oropharynx in patients with COVID-19 through the use of mouthwash containing cetylpyridinium chloride (CPC) (0.07%) in mouthwash.
详细描述
The objective of the clinical trial is to determine the short-term efficacy of cetylpyridinium chloride (CPC) mouthwashes to assess changes in the threshold cycle value of the analysis of the SARS-CoV-2 oropharyngeal saliva sample, in patients diagnosed with COVID-19 and with symptomatology compatible with the disease. A randomized double-blind pilot clinical trial (evaluator and patients) will be developed in patients with a diagnosis of COVID-19 and symptoms of the disease. The experimental group will perform a single rinse with a mouthwash containing Cetylpyridinium Chloride (CPC) while the placebo group will perform the same rinse, but with a harmless liquid that will act as a placebo. The study will be carried out in the Zaragoza III Health Sector, with patients belonging to the Zaragoza II Health Sector, collaborating with the "Seminario" health center and the Lozano Blesa Clinical University Hospital (HCULB). This project will be carried out in accordance with the CONSORT guidelines for clinical trials.
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
- Double (Participant, Investigator)
盲法说明
Randomized double-blind pilot clinical trial (evaluator and patients) in patients with a diagnosis of COVID-19 and symptoms of the disease.
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
- 是
入选标准
- •Outpatients older than 18 years and younger than 80 years.
- •Patients with a medical indication for a diagnostic test for active infection to SARS-CoV-2
- •Patients who present mild symptoms typical of COVID-19 and who have less than three days of evolution
- •Patients who have cognitive and motor skills to perform mouthwash correctly.
- •Patients who understand and speak Spanish
- •Patients who freely give their consent to participate in the study, after a correct understanding of its objectives and procedures.
排除标准
- •Patients with hospitalization criteria (moderate or severe symptoms)
- •Vulnerable populations such as pregnant, lactating,
- •Patients with recent medical diagnosis (≤ 1 month) of pneumonia
- •Patients with hyposialia
- •Patients with consumption of oral antiseptics (in the form of mouthwash containing CPC, povidone iodine rinses, alcohol mouthwash and essential oils) and toothpastes with CPC during the last month.
- •Patients with cognitive impairment
结局指标
主要结局
Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples
时间窗: 3 months
Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples before antd 2hours after mouthwashes
SARS-CoV-2 Nucleocapsid protein in saliva by ELISA
时间窗: 3 months
Quantitative determination of SARS-CoV-2 Nucleocapsid protein in saliva by ELISA
次要结局
未报告次要终点
研究者
Rosa Tarrago
Principal investigator
Instituto de Investigación Sanitaria Aragón