Effect of PVP-I Nasal Sprays vs Normal Saline Nasal Sprays on SARS-CoV-2 Nasopharyngeal Titers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2
研究概览
简要总结
The study aims to determine the safety and efficacy of povidone-iodine (PVP-I) containing nasal sprays as compared to isotonic saline nasal sprays in COVID-19 positive patients. The primary outcome measure is SARS-CoV-2 viral titers in the nasal cavity and nasopharynx. In vitro studies have shown PVP-I to be highly virucidal against the viruses which cause SARS and MERS. Additionally, clinical studies have shown PVP-I saline sprays to be well tolerated in human subjects. PVP-I oral rinses and sprays have been trialed as methods to reduce the incidence and symptoms of viruses which cause the "common cold."
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
- Double (Participant, Investigator)
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
- •Diagnosis of COVID-19 by lab test within 5 days of study participation
排除标准
- •Allergy to "iodine," shellfish, or food dye
- •Receiving intranasal steroids
- •Sinus surgery within 30 days of beginning the study
- •Intubated at the time of enrollment
- •Pregnancy
- •Participation in other COVID-19 studies - to be determined on a case by case basis
研究组 & 干预措施
Povidone-Iodine 2%
Participants will administer PVP-I 2% nasal spray for 5 days. Nasopharyngeal swabs will be taken on Day 1 at baseline, Day 1 at four hours post-first dose, and Day 5.
Participants will complete a daily symptom journal from Day 1 through Day 5.
干预措施: Povidone-Iodine 2% (Drug)
Povidone-Iodine 0.5%
Participants will administer PVP-I 0.5% nasal spray for 5 days. Nasopharyngeal swabs will be taken on Day 1 at baseline, Day 1 at four hours post-first dose, and Day 5.
Participants will complete a daily symptom journal from Day 1 through Day 5
干预措施: Povidone-Iodine 0.5% (Drug)
Isotonic saline 0.9%
Participants will administer two sprays of isotonic saline nasal spray for 5 days. Nasopharyngeal swabs will be taken on Day 1 at baseline, Day 1 at four hours post-first dose, and Day 5.
Participants will complete a daily symptom journal from Day 1 through Day 5.
干预措施: Isotonic saline 0.9% (Drug)
结局指标
主要结局
Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2
时间窗: Day 1 (baseline), Day 1 (1 hour), Day 3
Nasopharyngeal swabs were obtained and quantitative reverse transcription-polymerase chain reaction (RT-PCR) testing was performed to determine the viral load in the nasopharynx. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.
次要结局
- Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays(Assessed on days 3 and 5)
- Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2(Assessed on days 3 and 5)
- Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2(Assessed on days 3 and 5)
- Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2(Assessed on days 3 and 5)
- Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2(Assessed on days 3 and 5)
- Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2(Assessed on days 3 and 5)
- Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2(Assessed on days 3 and 5)
- Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2(Assessed on days 3 and 5)
- Compliance With Study Drug Administration(5 days)
- Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)(Day 1 (baseline), Day 30)