COVID-19
Conditions
Keywords
Nebulizer, MDI, Meter Dosed Inhaler, Filter, Spacer, COVID-19, Coronavirus disease 2019, SARS-CoV-2, Aerosol, Viral transmission
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 \[to be described by study team\]
Interventions
DRUGalbuterol sulfate (MDI)
albuterol sulfate inhalation aerosol delivered via metered-dose inhaler (MDI) with spacer
DRUGalbuterol sulfate (nebulizer)
albuterol sulfate inhalation aerosol delivered via nebulizer with filtered mouthpiece
Sponsors
Theravance Biopharma
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing and able to provide written informed consent, either themselves or via legally acceptable representative, prior to undergoing study procedures 2. Willing and able to comply with study-related procedures/assessments 3. Adults over 18 years of age 4. COVID-19 infection as confirmed by PCR from nasopharyngeal, oropharyngeal swabs and/or saliva specimen taken within the previous 5 days
Exclusion criteria
1. 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. 2. Presence of significant comorbidity that, in the opinion of the investigator, makes the subject unsuitable for participation in the study 3. Known or suspected hypersensitivity to albuterol, history of paradoxical bronchospasm, or significant cough response to albuterol 4. 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) 5. Active or incompletely treated pulmonary infections, such as tuberculosis (or known history of nontuberculosis mycobacterium) over past 12 months 6. Pregnant or currently breast feeding, or a positive urine pregnancy dip test performed at baseline (women only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load | 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. |
Countries
United States
Outcome results
None listed