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临床试验/NCT05184205
NCT05184205已完成不适用

Photodynamic Therapy for SARS-CoV-2 Viral Reduction in the Upper Airway in PCR-positive Asymptomatic Individuals.

Ondine Biomedical Inc.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
SARS-CoV-2 viral titer reduction

研究概览

简要总结

This is a single-center open-label study to evaluate antimicrobial photodynamic therapy (aPDT) for upper airway decolonization in patients presenting with SARS-CoV-2 positive antigen test with mild or no symptoms of COVID-19.

详细描述

There is a wide variety of people who test positive for SARS-CoV-2. This is directly dependent upon their exposure to the virus, their age and any medical comorbidities that they may have. At this time, it is not possible to predict who will have an adequate immune response to avoid getting COVID-19. Since this remains unpredictable a universal approach to treating SARS-CoV-2 positive patients may be the optimal approach.

The rational for this study design is that in a real world setting numerous patients across a wide variety of conditions will receive testing for SARS-CoV-2 for a variety of reasons. For those who test positive and are asymptomatic or have only mild symptoms, the current standard of care is observation and quarantine. The incubation period can range from 2-14 days with a mean of 5-6 days. Depending upon an individual's original inoculum of virus, comorbidities and other factors they may progress to COVID-19. Preemptive treatment during this time frame may avoid or mitigate COVID-19 disease severity. In certain high-risk individuals attenuating the disease may avoid hospitalization or death, ICU admission and shorten hospital stays.

The nasal disinfection process rapidly and lethally disrupts the microbial cell wall, leaving human tissue unharmed. The topically applied photosensitizer formulation selectively stains bacteria by binding with microbial cell wall components. The red light is absorbed by the photosensitizer molecules, causing electronic state transitions within the photosensitizer. The excited photosensitizer immediately transfers energy to surrounding molecular oxygen, thereby producing reactive oxygen species (ROS) that are responsible for the lethal cell wall disruption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The placebo control arm will include the application of saline isotonic solution and the introduction of the PDT device with no powering on. Due to the characteristics of the device, and the need for the investigator to deliberately not switching it on, it is clear that there cannot be a blind scheme in this trial.

入排标准

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

入选标准

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female ≥ 18 years of age
  • Patient showing a positive test for SARS-CoV-2 with < 26 Ct of an FDA-approved PCR test who is symptomatic or flu-like illness or pneumonia
  • Ability to tolerate an 12-minute non-painful nasal light illumination

排除标准

  • Inability to tolerate insertion of the light illuminator due to oronasal size, shape, or anatomical variants
  • Known allergic reactions to components of the nasal decolonization treatment including methylene blue or chlorhexidine gluconate.
  • COVID-19 illness that is moderate or severe in nature.

结局指标

主要结局

SARS-CoV-2 viral titer reduction

时间窗: Immediately following treatment and on days 3, 7, and 14.

Change from baseline PCR count with testing on days 3, 7 and 14

次要结局

  • General safety of nasal photodisinfection(14 days post treatment)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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