Testing a new device for detecting COVID-19 in breath and nasal samples
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
This study is testing a new device that checks breath and nasal samples for COVID-19 to see if it works better than regular nasal swabs and at-home tests for people aged 5 and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 330 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Cantor BioConnect, Inc. Research network |
| Locations | 6 sites (S. Gate, California and 5 other locations) |
| Trial ID | NCT06047067 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the Bioaerosol Sampling Device (BSD) for its effectiveness in sampling bioaerosols and nasal secretions to detect COVID-19 viral particles. The study will compare the BSD's performance against traditional nasal swab tests using RT-PCR and at-home molecular and antigen assays. By providing a non-invasive and potentially more comfortable testing method, the BSD could enhance early detection of COVID-19 in patients. Participants will include individuals aged 5 and older who are seeking COVID-19 testing, regardless of symptoms.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 5 years or older who are seeking COVID-19 testing and have an unknown COVID-19 status.
Not a fit: Patients who are unable to tolerate nasal sampling or are currently enrolled in other trials involving nasal cavity sampling may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could lead to earlier and more comfortable COVID-19 testing, potentially reducing virus transmission.
How similar studies have performed: While the approach of using bioaerosol sampling is innovative, similar studies have shown promise in enhancing non-invasive testing methods for respiratory viruses.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
S. Gate, California and 5 other locations
- JPRA Enterprise, LLC — S. Gate, California, United States (Recruiting)
- Alfa Medical Research — Hollywood, Florida, United States (Recruiting)
- Alfa Medical Urgent Care — Pembroke Pines, Florida, United States (Recruiting)
- HDH Research — Houston, Texas, United States (Recruiting)
- HDH Research — Houston, Texas, United States (Recruiting)
- HDH Research — Humble, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Robert Azurin, MD — JPRA Enterprises, LLC
- Study coordinator: Study Cooridnator
- Email: emerald@cantorbioconnect.com
- Phone: (619) 635-5843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.