A Phase II, Randomized, Open-label, Single-institution Study of the Effects of Povidone Iodine Oral Gargles and Nasal Rinses on Viral Load in Patients With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Viral load (and/or cycle time to PCR as a proxy for quantitative viral load) in the nasopharynx and oropharynx
研究概览
简要总结
For this study, 48 patients who have been diagnosed with COVID-19 will be randomly assigned to four study groups: control, saline, chlorhexidine gluconate, and povidone-iodine. Each patient will be asked to gargle with a solution of either saline, chlorhexidine gluconate, or povidone-iodine or nothing (control group) as well as spray the same solution in their nose four times daily. Patients will then be tested for COVID-19 once daily in the evening for 7 days and viral loads will be measured.
详细描述
COVID-19 has emerged as a worldwide pandemic and there is a strong need for identification of any measures that can be used to treat this illness or reduce its transmission from person to person. Povidone-iodine has been shown to have virucidal properties against multiple viruses including against the virus that causes SARS which is very similar in makeup to the virus causing COVID-19.
The investigators hypothesize that 4x daily use of oral gargles and nasal rinses using a povidone iodine solution will help to reduce the viral load in the nasopharynx and oropharynx in patients who are COVID-19+. If this hypothesis is shown to be true this could potentially have an impact on time to recovery of clinical symptoms as well as reduce shedding of the virus by infected patients. A time course of 7 days was chosen in order to recognize a trend in the viral load over time for patients receiving each of the interventions. Chlorhexidine gluconate and saline rinses were chosen as additional treatment arms as these are frequently used for oral and nasal hygiene and their role in affecting viral load is currently unknown.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive test for COVID-19
- •Age 18-79 years
- •Willing and able to perform oral gargles and nasal rinses four times daily
- •Exclusion Criteria
- •Requiring mechanical ventilation
- •Unable or unwilling to perform oral gargles and nasal rinses four times daily
- •History of chronic upper respiratory tract disease
- •Known iodine allergy
- •History of thyroid disease
排除标准
- 未提供
研究组 & 干预措施
Saline oral/nasal rinse
干预措施: Saline oral/nasal rinse (Drug)
0.5% Povidone/Iodine oral/nasal rinse
干预措施: 0.5% Povidone/Iodine oral/nasal rinse (Drug)
0.12% Chlorhexidine oral/nasal rinse
干预措施: 0.12% Chlorhexidine oral/nasal rinse (Drug)
结局指标
主要结局
Viral load (and/or cycle time to PCR as a proxy for quantitative viral load) in the nasopharynx and oropharynx
时间窗: 7 days
nasopharyngeal swab for viral PCR will be taken at the end of each day for 7 days
次要结局
- Oxygen requirement of the patient(7 days)
- Oxygen saturation of the patient(7 days)