A Phase 4 Study to Evaluate Nasopharyngeal SARS-CoV-2 Viral Shedding After Halodine Nasal Antiseptic in Patients With COVID-19
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 主要终点
- Nasopharyngeal SARS-CoV-2 Viral Load
研究概览
简要总结
Povidone iodine (PVP-I) is a well-known broad spectrum, resistance free antimicrobial agent that has a long history of safe and effective use. Halodine Nasal Antiseptic is formulated for topical application PVP-I to nasal passages, and has demonstrated effectiveness against SARS-COV-2 in vitro - 99.99% inactivation within 15 seconds. This study will evaluate the ability of Halodine Nasal Antiseptic to impact SARS-CoV-2 in vivo.
详细描述
This is a multicenter, phase 4 prospective, single-cohort study in adult male and female volunteers hospitalized with COVID-19. Baseline nasopharyngeal swabs will be performed on all individuals. Halodine Nasal Antiseptic will then be applied to the anterior nares. Serial nasopharyngeal samples will then be collected at specified time points after the application. All samples will be tested for SARS-CoV-2 by real-time reverse transcription (rRT)-PCR assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Hospitalized with COVID-19
- •Positive SARS-CoV-2 (rRT)-PCR within 48 hours of enrollment
排除标准
- •Allergies to iodine-containing compounds
研究组 & 干预措施
Halodine Nasal Antiseptic
Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP
Single topical administration
干预措施: Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP (Drug)
结局指标
主要结局
Nasopharyngeal SARS-CoV-2 Viral Load
时间窗: 4 hours
Real-time reverse transcription (rRT)-PCR assay for SARS-CoV-2
次要结局
未报告次要终点