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临床试验/NCT04364802
NCT04364802已完成2 期

Povidone-Iodine Intranasal for Prophylaxis in Front-line Health-care Personnel and Inpatients During the Sars-CoV-2 Pandemic

Nikita Gupta1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2020年4月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Nikita Gupta
入组人数
98
试验地点
1
主要终点
Percent of Community Participants Testing Positive for COVID-9.

研究概览

简要总结

Povidone-iodine (PVP-I) is a broad-spectrum antiseptic with activity against bacteria, fungi, and viruses. It has been previously used in both intranasal preparations against Methicillin Resistant Staphylococcus Aureus (MRSA) as well as oral preparations in in-vitro studies of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV), Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV), influenza H1N1, and rotavirus with good efficacy. This study will evaluate the efficacy of PVP-I as prophylaxis in Coronavirus Disease 2019 (COVID19)-negative front-line health care workers, hospital patients, and community members.

详细描述

The COVID-19 pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus - 2 (SARS-CoV-2), has been implicated in over 12 million cases and counting in the United States alone and has killed at least 1300 health care workers and >250,000 citizens. This, added to the national shortage of personal protective equipment (PPE) and the need to reuse PPE, lends to the significantly increased risk to healthcare providers. At the beginning of this trial, there were only 360,000 cases.

The highest concentration of viral particles resides within the nasopharynx. The virus is thought to spread via respiratory droplets with the potential for transmission via inhalation of droplets, contact to the nose and mouth with infected materials, and airborne transmission. Given that frontline workers are involved in high-risk procedures including intubation, bronchoscopy, proning patients (which can lead to droplet production) and in some cases are reusing PPE, finding ways to reduce viral load or viral exposure are paramount.

Povidone-iodine (PVP-I) is a broad-spectrum antiseptic with activity against bacteria, fungi, and viruses. It has been previously used in both intranasal preparations against MRSA as well as oral preparations in in-vitro studies of SARS-CoV-2, MERS-CoV, H1N1, and rotavirus with good efficacy.

Due to the known breadth of its antiviral activity and similarities in molecular structure, it can be extrapolated that PVP-I should have robust activity against SARS-CoV-2. Eggers et al found that at a concentration of 1% there was a reduction of viral activity of 99.99% in in-vitro assays. At 2 minutes, a concentration of 0.23% was enough to reduce viral loads appreciably. New data has demonstrated efficacy in-vitro of PVP-I against SARS-CoV-2 at low concentrations.

PVP-I is widely used as an antiseptic and is well-tolerated and has been shown to have little to no effect on mucociliary clearance, olfaction, or thyroid function if iodine holidays are taken, although care must be utilized in monitoring.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthcare worker OR
  • patient with expected hospital stay of 7+ days OR
  • patient admitted for major surgery OR
  • community member
  • COVID19 negative by nasal swab test
  • asymptomatic for COVID19
  • able to consent

排除标准

  • positive for COVID19 by nasal swab
  • symptomatic for COVID19
  • unable to consent

研究组 & 干预措施

Healthcare Workers - PVP-I

Experimental

Front-line healthcare workers (FLCHW) who are negative for COVID-19 will receive standard PPE and a pre- and post-study test for COVID-19. Additionally, they will receive PVP-I spray and gargle.

干预措施: Povidone-Iodine Nasal Spray and Gargle (Drug)

Inpatients - PVP-I

Experimental

Inpatients who have a 7+ day hospitalization or who are set to undergo a significant surgical procedure will receive standard care and a pre- and post-study COVID-19 test. Additionally, they will receive PVP-I gargle and nasal sprays that will be applied shortly after admission or perioperatively.

干预措施: Povidone-Iodine Nasal Spray and Gargle (Drug)

Community - PVP-I

Experimental

Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test. Additionally, they will receive PVP-I gargle and nasal sprays.

干预措施: Povidone-Iodine Nasal Spray and Gargle (Drug)

结局指标

主要结局

Percent of Community Participants Testing Positive for COVID-9.

时间窗: 3 weeks

Percent of community participants that become positive for COVID-19 during the study.

Percent of Healthcare Workers Testing Positive for COVID-19.

时间窗: 3 weeks

Percent of healthcare workers that become positive for COVID-19 during the study.

Percent of Patients Testing Positive for COVID-9.

时间窗: 2 weeks

Percent of patients that become positive for COVID-19 during the study.

次要结局

  • PVP-I Ease of Use(3 weeks)
  • PVP-I Comfort(3 weeks)

研究者

发起方
Nikita Gupta
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nikita Gupta

Assistant Professor

University of Kentucky

研究点 (1)

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