Clinical trial NCT04681079: Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With COVID-19
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Nebulizer
MDI
Meter Dosed Inhaler
Filter
Spacer
COVID-19
Coronavirus disease 2019
SARS-CoV-2
Aerosol
Viral transmission
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2020-12-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with mild to moderate COVID-19

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 \[to be described by study team\]

Eligibility criteria: 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)

Primary outcomes:
measure: Viral Load
timeFrame: Baseline, Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Theravance Biopharma Investigational Site
state: Kansas
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: