A 2-Period, Crossover Study to Assess the Impact of Nebulizer With Filtered Mouthpiece vs MDI With Spacer on Viral Load in Rooms of Subjects With Mild to Moderate COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Viral Load
研究概览
简要总结
A randomized, 2-period crossover, single-center, open-label study for viral sample collection. After initiation of inhaled therapy with nebulizer or MDI, cascade impactors and surface samplers will be used to assess viral loads in rooms of subjects with COVID-19.
详细描述
Observational Study Model = Other [non-treatment; impact on external location (rooms and surfaces)]
Time Perspective = Other [viral load samples taken at various time points after nebulization or MDI administered]
Sampling Method = Non-probability sample [to be described by study team]
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Willing and able to provide written informed consent, either themselves or via legally acceptable representative, prior to undergoing study procedures
- •Willing and able to comply with study-related procedures/assessments
- •Adults over 18 years of age
- •COVID-19 infection as confirmed by PCR from nasopharyngeal, oropharyngeal swabs and/or saliva specimen taken within the previous 5 days
排除标准
- •Subjects currently receiving mechanical ventilation or noninvasive positive-pressure ventilation, or subjects who, in the opinion of the investigator, will require ventilatory support (i.e., mechanical ventilation or noninvasive positive-pressure ventilation) within the next 12 hours Note: Signs of impending need for ventilatory support include pronounced hypoxia despite supplemental oxygen >6 L/min, prolonged respiratory rate (i.e., >30 breaths per minute), signs of respiratory muscle fatigue, or paradoxical diaphragm.
- •Presence of significant comorbidity that, in the opinion of the investigator, makes the subject unsuitable for participation in the study
- •Known or suspected hypersensitivity to albuterol, history of paradoxical bronchospasm, or significant cough response to albuterol
- •Participating in other clinical trials related to COVID-19 thought to interfere with study interpretation (e.g., antivirals or antibodies that might change the viral load over the course of a day; subjects should not receive antibody therapy within 24 hours before the baseline period)
- •Active or incompletely treated pulmonary infections, such as tuberculosis (or known history of nontuberculosis mycobacterium) over past 12 months
- •Pregnant or currently breast feeding, or a positive urine pregnancy dip test performed at baseline (women only)
研究组 & 干预措施
Crossover Sequence 1
Subjects randomized to receive commercially available albuterol sulfate via MDI with spacer first, followed by albuterol sulfate via nebulizer with filtered mouthpiece.
干预措施: albuterol sulfate (MDI) (Drug)
Crossover Sequence 1
Subjects randomized to receive commercially available albuterol sulfate via MDI with spacer first, followed by albuterol sulfate via nebulizer with filtered mouthpiece.
干预措施: albuterol sulfate (nebulizer) (Drug)
Crossover Sequence 2
Subjects randomized to receive commercially available albuterol sulfate via nebulizer with filtered mouthpiece first, followed by albuterol sulfate via MDI with spacer.
干预措施: albuterol sulfate (MDI) (Drug)
Crossover Sequence 2
Subjects randomized to receive commercially available albuterol sulfate via nebulizer with filtered mouthpiece first, followed by albuterol sulfate via MDI with spacer.
干预措施: albuterol sulfate (nebulizer) (Drug)
结局指标
主要结局
Viral Load
时间窗: Baseline, Day 1
Change in viral load from baseline at each sample point (room air and surfaces). This outcome measure is listed as exploratory in the protocol.
次要结局
未报告次要终点