NCT04563689已完成不适用
Efecto de un Enjuague Bucal Con Clorhexidina al 0.12% y Cloruro de Cetil Piridinio al 0.05% en la Carga Viral en Saliva en Pacientes COVID-19 + Hospitalizados o Que Esten Recibiendo Cuidado médico en Casa en Cali - 2020.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Dentaid SL
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- exploratory change in viral load
研究概览
简要总结
Randomized, double-blind, placebo-controlled pilot study to evalaute viral load in saliva of COVID19+ patients using quantitative PCR, before and after use of active or placebo rinses
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be positive for SARS-CoCV-2 real-time PCR test
- •SARS-CoV-2 patients positive, with home and/or hospitalized care.
- •Have a medical condition that allows them to perform a mouthwash for 1 minute.
排除标准
- •People with impaired lung function who do not allow them to rinse.
- •Patients with antiviral treatment for Covid-
- •Patients with diseases that affect saliva, Sjogren's syndrome, and Systemic Lupus Erythematosus.
- •Any cause of immunosuppression (primary or secondary), including HIV.
- •Chronic kidney disease 3b or older, Coronary heart disease, Uncontrolled diabetes (Hb1Ac >7), Uncontrolled high blood pressure, Uncontrolled thyroid disease, history of cancer less than 1 year
结局指标
主要结局
exploratory change in viral load
时间窗: baseline (pre-rinse) and 15 min, 1 hour, 2 hours and 5 days after initial oral rinse
change versus baseline in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR
次要结局
- number of patients who have decrease in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR(15 min, 1 hour, 2 hours and 5 days after initial oral rinse)
- number of patients with adverse events during 5 days study duration(through study completion in day 5)
研究者
研究点 (2)
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