Bioaerosol Sampling Device (BSD) Clinical Study
Purpose
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.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Over 5 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Cross-Sectional
Recruiting Locations
S. Gate, California 90280
Robert Azurin, MD
562-547-1799
Hollywood, Florida 33204
Ausberto Hidalgo, MD
754-263-3626
Pembroke Pines, Florida 33029
David Benson, MD
Houston, Texas 77009
Hermes Hernandez, MD
Houston, Texas 77022
Francisco Ortiz, MD
346-282-4426
Humble, Texas 77338
Damari Duarte, MD
More Details
- NCT ID
- NCT06047067
- Status
- Recruiting
- Sponsor
- Cantor BioConnect, Inc.
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.