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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Theravance Biopharma
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Viral Load
Study Overview
Brief Summary
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.
Detailed Description
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]
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: albuterol sulfate (nebulizer) (Drug)
Outcomes
Primary Outcomes
Viral Load
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported