Clinical trial NCT06047067: Bioaerosol Sampling Device (BSD) Clinical Study
Official title: BIOAEROSOL SAMPLING DEVICE (BSD) CLINICAL STUDY: Performance of Respiratory Pathogen Bioaerosol Sampling Device Compared to Matched Swab Sample With Molecular and Antigen Assays That Can Detect SARS-CoV-2 Phase II Validation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: COVID-19
Rapid diagnostic test
SARS-CoV-2
SARS-CoV-1
Lead sponsor: Cantor BioConnect, Inc.
Sponsor class: NETWORK
Collaborators: name: 3M
name: Biomedical Advanced Research and Development Authority
name: JPRA Enterprises, LLC
First posted: 2023-09-21
Enrollment: 330
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient arriving at a participating site wanting to be tested with COVID-19, status unknown. Demographic information will be collected. Best efforts will be made to enroll subjects with diverse socioeconomic and educational obtainment.

Brief summary: The goal of this clinical trial is to learn about the bioaerosol sampling device (BSD) and how it can sample patient bioaerosols (breath) and patient's nares for the detection of COVID-19 viral particles in patients seeking to be tested for COVID-19.

Detailed description: SARS-CoV-2, the virus which causes COVID-19, is transmissible through bioaerosols. Routine accessible, non-invasive, sensitive testing could play a role in reducing the spread of the disease and controlling the current and future pandemics. The Bioaerosol Sampling Device may offer both comfort and the potential to increase the ability to detect patients earlier in the infection cycle than a swab. The primary objective of the research is to generate BSD performance data with detection by RT-PCR and at-home molecular and antigen assays, compared to nasal swab comparator detected by EUA or 510k cleared RT-PCR.

Eligibility criteria: Inclusion Criteria:

Any patient 5 years or older who wants to be tested Patients may be symptomatic or asymptomatic based on CDC guidelines Patients may be suspected of having COVID-19 based on CDC guidelines Patient's COVID-19 status should be unknown Patients younger than 12 should be assisted by an adult

Exclusion Criteria:

Unable to self-consent Concurrent enrollment in other trials involving same-day nasal cavity sampling

Contraindication to nasal sampling as performed according to the clinical site policies and procedures, including:

Unable to tolerate Nasal Swab Sampling History of perforation of the nasal septum or prone to nosebleed Head or facial injury/surgery within the past 6 months On anticoagulant therapy including anti-platelet therapy Nasal or nasal aspirate and nasal wash performed as standard of care.

Primary outcomes:
measure: BSD detection of SARS-CoV-2: The primary objective of the research is to generate BSD performance data with detection by RT-PCR and at-home molecular and antigen assays, compared to nasal swab comparator detected by EUA or 510k cleared RT-PCR.
timeFrame: 1 year
Secondary outcomes:
measure: BSD performance data: Generate and evaluate the performance data evaluated based on virus load.
timeFrame: 1 year
Other outcomes:
Locations:
city: S. Gate
country: United States
facility: JPRA Enterprise, LLC
state: California
city: Hollywood
country: United States
facility: Alfa Medical Research
state: Florida
city: Pembroke Pines
country: United States
facility: Alfa Medical Urgent Care
state: Florida
city: Houston
country: United States
facility: HDH Research
state: Texas
city: Houston
country: United States
facility: HDH Research
state: Texas
city: Humble
country: United States
facility: HDH Research
state: Texas
Study officials:
affiliation: JPRA Enterprises, LLC
name: Robert Azurin, MD
role: PRINCIPAL_INVESTIGATOR
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