Status:
COMPLETED
Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With COVID-19
Lead Sponsor:
Theravance Biopharma
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 18 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04681079
Start Date
May 4 2021
End Date
January 18 2022
Last Update
January 28 2022
Active Locations (1)
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1
Theravance Biopharma Investigational Site
Kansas City, Kansas, United States, 66160