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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.
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]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albuterol sulfate (MDI) | Drug | albuterol sulfate inhalation aerosol delivered via metered-dose inhaler (MDI) with spacer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load | Change in viral load from baseline at each sample point (room air and surfaces). This outcome measure is listed as exploratory in the protocol. | Baseline, Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with mild to moderate COVID-19
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theravance Biopharma Investigational Site | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| albuterol sulfate (nebulizer) | Drug | albuterol sulfate inhalation aerosol delivered via nebulizer with filtered mouthpiece |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004864 | Equipment and Supplies |