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 detectionof COVID-19 viral particles in patients seeking to be tested for COVID-19.
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.
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.
JPRA Enterprise, LLC
S. Gate, California, United States
Alfa Medical Research
Hollywood, Florida, United States
Alfa Medical Urgent Care
Pembroke Pines, Florida, United States
HDH Research
Houston, Texas, United States
HDH Research
Houston, Texas, United States
HDH Research
Humble, Texas, United States
Study Cooridnator
(619) 635-5843
emerald@cantorbioconnect.com
Robert Azurin, MD, Principal Investigator
JPRA Enterprises, LLC