BIOAEROSOL SAMPLING DEVICE (BSD) CLINICAL STUDY: Performance of Respiratory Pathogen Bioaerosol Sampling Device Compared to Matched Swab Sample With Molecular and Antigen Assays That Can Detect SARS-CoV-2 Phase II Validation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 4
- 主要终点
- BSD detection of SARS-CoV-2: The primary objective of the research is to generate BSD performance data with detection by RT-PCR and at-home molecular and antigen assays, compared to nasal swab comparator detected by EUA or 510k cleared RT-PCR.
研究概览
简要总结
The goal of this clinical trial is to learn about the bioaerosol sampling device (BSD) and how it can sample patient bioaerosols (breath) and patient's nares for the detection of COVID-19 viral particles in patients seeking to be tested for COVID-19.
详细描述
SARS-CoV-2, the virus which causes COVID-19, is transmissible through bioaerosols. Routine accessible, non-invasive, sensitive testing could play a role in reducing the spread of the disease and controlling the current and future pandemics. The Bioaerosol Sampling Device may offer both comfort and the potential to increase the ability to detect patients earlier in the infection cycle than a swab. The primary objective of the research is to generate BSD performance data with detection by RT-PCR and at-home molecular and antigen assays, compared to nasal swab comparator detected by EUA or 510k cleared RT-PCR.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient 5 years or older who wants to be tested Patients may be symptomatic or asymptomatic based on CDC guidelines Patients may be suspected of having COVID-19 based on CDC guidelines Patient's COVID-19 status should be unknown Patients younger than 12 should be assisted by an adult
排除标准
- •Unable to self-consent Concurrent enrollment in other trials involving same-day nasal cavity sampling
- •Contraindication to nasal sampling as performed according to the clinical site policies and procedures, including:
- •Unable to tolerate Nasal Swab Sampling History of perforation of the nasal septum or prone to nosebleed Head or facial injury/surgery within the past 6 months On anticoagulant therapy including anti-platelet therapy Nasal or nasal aspirate and nasal wash performed as standard of care.
结局指标
主要结局
BSD detection of SARS-CoV-2: The primary objective of the research is to generate BSD performance data with detection by RT-PCR and at-home molecular and antigen assays, compared to nasal swab comparator detected by EUA or 510k cleared RT-PCR.
时间窗: 1 year
Aim 1 Objective 1: The primary objective of Aim 1 (A1O1) is to generate and evaluate BSD performance data for patients enrolled within the first 3 days of symptoms, with detection by RT-PCR and at-home molecular and antigen assays, compared to Nasal Swab Comparator detected by EUA or 510k cleared RT-PCR assays. Aim 1 Objective 2a: The secondary objective (A1O2a) of Aim 1 is to generate and evaluate the same BSD performance data as Aim 1 objective 1, but to do so for patients enrolled within the first 7 days of symptom onset. Aim 1 Objective 2b: The secondary objective (A1O2b) of Aim 1 is to generate and evaluate the same BSD performance data as Aim 1 objective 1, but to do so for any patients seeking to get tested for SARS-CoV-2 test, regardless of presence of symptoms or symptom onset.
次要结局
- BSD performance data: Generate and evaluate the performance data evaluated based on virus load.(1 year)