Can a Sinus Rinse and Mouth Wash Reduce Viral Load in COVID-19 Positive Individuals and Their Co-residents?
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in viral load in the oral and nasopharyngeal cavity
研究概览
简要总结
COVID-19 is highly infectious and transmission of the virus is thought to be similar to that of influenza which can be transferred through droplets released when a person coughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may be an important way to deliver treatments that could reduce the amount of a virus that is present in the nose and mouth. This also could mean that there is less virus available to pass on to others. We want to see if the use of nose rinses and mouth washes using Povidone-Iodine will reduce the the amount of virus in the nose and throat of people who have tested positive for COVID-19 disease and also reduce the spread of infection within their household.
详细描述
COVID-19 is highly infectious and transmission of the virus is thought to be similar to that of influenza which can be transferred through droplets released when a person coughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may be an important way to deliver treatments that could reduce the amount of a virus that reaches other parts of the body. This also could mean that there is less virus available to pass on to others.
We want to see if the use of nasal rinsing and mouth washes will reduce the spread of infection within your household by reducing and removing the virus from your mouth and nose.
Once the participants have been recruited they will be randomly allocated to one of two groups. Each arm will have the same number of participants. The two arms will be :
- nose rinse and mouthwash with Isotonic saline alone. This will be the control arm.
- nose rinse and mouthwash with Povidone-Iodine taken 3 times a days for three days.
Before treatment begins, each participant will have one pre-treatment swab of the back of the nose and the back of the throat taken.
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
- •Healthcare worker OR patient on a general ward who has had a positive COVID-19 test OR a person who is co-residing with an affected staff member or patient who is now at home in self-isolation.
- •capable of giving informed consent
- •able to self-administer the sinus rinses and mouth washes
- •able to have healthcare professional-led swabs OR self-administer the oral and nasopharyngeal swabs
- •aged 18 years and over.
排除标准
- •not capable of giving informed consent
- •unable to self-administer the sinus rinses and mouth washes
- •unable to have healthcare professional-led swabs OR self-administer the oral, nasal and/OR nasopharyngeal swabs
- •unable to send swabs to the study team via the approved methods described in participant information leaflet and protocol
- •under 18 years of age.
- •known hypersensitivity to Iodine
- •at risk of aspiration due to an unsafe swallow
- •hyperthyroidism or other manifest thyroid diseases
- •herpetiform dermatitis (Duhring's disease)
- •planned or undergoing radioiodine treatment
- •actively Breastfeeding
研究组 & 干预措施
Povidone-Iodine
0.23% sinus rinse and mouthwash three times daily (tds) for days 1-3 of study
干预措施: Povidone-Iodine (Drug)
Normal Saline
sinus rinse and mouthwash three times daily (tds) for days 1-3 of study
干预措施: Normal saline (Drug)
结局指标
主要结局
Change in viral load in the oral and nasopharyngeal cavity
时间窗: Day 0, 2, 3, 7, 14
viral load as measured by real time polymerase chain reaction (PCR)
次要结局
- Symptom severity in primary participants and co-residents(Days 0 to 14)