Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With SARS-CoV-2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7
研究概览
简要总结
The SARS-CoV-2 coronavirus pandemic is responsible for more than 180,000 deaths worldwide and 20,000 deaths in France. To date, no treatment or vaccine has been successful. Povidone-iodine is an antiseptic suitable for use on the skin and mucosa with potent virucidal activity, particularly against coronaviruses. It is marketed for oro-nasopharyngeal decolonization.
24 patients with positive nasopharyngeal SARS-CoV-2 carriage will be randomized (1:1) in an experimental group (benefiting from povidone iodine decolonization) or a control group. Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days. Patients will be followed for 7 days to evaluate the efficacy and safety of povidone iodine decolonization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults (age over 18 yrs) of both sexes
- •With positive SARS-CoV-2 carriage by RT-PCR
- •Having given their written consent after having been informed
- •Exclusion Criteria
- •Patient with low viral load (threshold cycle [Ct] > 25 per RT-PCR),
- •Patient unable to perform oro-nasopharyngeal decolonization
- •Known hypersensitivity to one of the constituents, particularly to povidone-iodine,
- •History of dysthyroidism,
- •Known coagulopathy,
- •Participation in another clinical trial aimed at reducing viral load in patients with SARS-CoV-2,
- •Pregnant or breastfeeding women, or women of childbearing age without effective contraception
- •Patients not covered by a social security scheme
- •Patients with enhanced protection
排除标准
- 未提供
研究组 & 干预措施
Decolonization
1% Povidone iodine mouthwash (95 mL), gargle, and nasal spray (2,5 mL by nostril), and 10% nasal gel (one drop). All four time a day for five days.
干预措施: Povidone-Iodine (Drug)
结局指标
主要结局
Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day7
时间窗: Day 7
次要结局
- Thyroid tests at Day0 and Day7(Day0 and Day7)
- Patient satisfaction at Day7 using a numerical comfort scale, graduated from 0 (any discomfort) to 10 (maximum possible discomfort)(Day7)
- Need for ward or intensive care hospitalization(Day0, Day1, Day3, Day5 and Day7)
- Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal carriage(Day0, Day1, Day3, Day5 and Day7)
- Delay between inclusion and negativation of SARS-CoV-2 nasopharyngeal cell cultures(Day0, Day1, Day3, Day5 and Day7)
- Daily presence of clinical signs in favour of COVID-19, including respiratory distress using NYHA scale, chest pain, anosmia, agueusia, tiredness, cough, stiffness, nasal congestion, dysphagia and diarrhea(Day0, Day1, Day3, Day5 and Day7)