Bioaerosol Sampling Device (BSD) Clinical Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 330

Contacts and Locations

• Study Contact: Name: Study Cooridnator; Phone Number: (619) 635-5843; Email: emerald@cantorbioconnect.com

Study Locations

• United States
  • California
    • S. Gate, California, United States, 90280
      • Recruiting
      • JPRA Enterprise, LLC
      • Contact: Robert Azurin, MD; Phone Number: 562-547-1799
  • Florida
    • Hollywood, Florida, United States, 33204
      • Recruiting
      • Alfa Medical Research
      • Contact: Ausberto Hidalgo, MD; Phone Number: 754-263-3626
    • Pembroke Pines, Florida, United States, 33029
      • Recruiting
      • Alfa Medical Urgent Care
      • Contact: David Benson, MD
  • Texas
    • Houston, Texas, United States, 77009
      • Recruiting
      • HDH Research
      • Contact: Hermes Hernandez, MD
    • Houston, Texas, United States, 77022
      • Recruiting
      • HDH Research
      • Contact: Francisco Ortiz, MD; Phone Number: 346-282-4426
    • Humble, Texas, United States, 77338
      • Recruiting
      • HDH Research
      • Contact: Damari Duarte, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Aim 1 Objective 1: The primary objective of Aim 1 (A1O1) is to generate and evaluate BSD performance data for patients enrolled within the first 3 days of symptoms, 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 assays. Aim 1 Objective 2a: The secondary objective (A1O2a) of Aim 1 is to generate and evaluate the same BSD performance data as Aim 1 objective 1, but to do so for patients enrolled within the first 7 days of symptom onset. Aim 1 Objective 2b: The secondary objective (A1O2b) of Aim 1 is to generate and evaluate the same BSD performance data as Aim 1 objective 1, but to do so for any patients seeking to get tested for SARS-CoV-2 test, regardless of presence of symptoms or symptom onset.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BSD performance data: Generate and evaluate the performance data evaluated based on virus load.	Aim 2 Objective 1: The primary objective of Aim 2 (A2O1) is to generate and evaluate BSD performance data for enrolled patients, with detection by at-home antigen assays, compared to Nasal Swab Comparator detected by EUA or 510k cleared RT-PCR assays with Ct values of less than 30. This objective will focus will be to evaluate the sensitivity of the BSD to detect SARS-CoV-2 virus with at-home antigen tests among specimens with a nasal swab RT-PCR Ct value of less than 30. Aim 2 Objective 2: The secondary objective of Aim 2 (A2O2) is to generate and evaluate BSD performance data for enrolled patients, with detection by PCR, compared to Nasal Swab Comparator detected by EUA or 510k cleared RT-PCR assays, in order to derive a correlation between virus load collected via BSD and virus load collected via nasal swab, both as measured by RT-PCR Ct value on the same RT-PCR assay.	1 year

Collaborators and Investigators

• Sponsor: Cantor BioConnect, Inc.
• Collaborators: Biomedical Advanced Research and Development Authority; 3M; JPRA Enterprises, LLC
• Investigators: Principal Investigator: Robert Azurin, MD, JPRA Enterprises, LLC

Publications and helpful links

General Publications

• Li J, Fine J. On sample size for sensitivity and specificity in prospective diagnostic accuracy studies. Stat Med. 2004 Aug 30;23(16):2537-50. doi: 10.1002/sim.1836.
• Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available. Erratum In: Lancet Infect Dis. 2020 Sep;20(9):e215.
• Wang CJ, Ng CY, Brook RH. Response to COVID-19 in Taiwan: Big Data Analytics, New Technology, and Proactive Testing. JAMA. 2020 Apr 14;323(14):1341-1342. doi: 10.1001/jama.2020.3151. No abstract available.
• Mercer TR, Salit M. Testing at scale during the COVID-19 pandemic. Nat Rev Genet. 2021 Jul;22(7):415-426. doi: 10.1038/s41576-021-00360-w. Epub 2021 May 4.
• Marra P, Colacurcio V, Bisogno A, De Luca P, Calvanese M, Petrosino M, De Bonis E, Troisi D, Cassandro C, Cavaliere M, Ralli M, Cassandro E, Scarpa A. Evaluation of Discomfort in Nasopharyngeal Swab Specimen Collection for SARS-CoV-2 Diagnosis. Clin Ter. 2021 Sep 29;172(5):448-452. doi: 10.7417/CT.2021.2357.
• Obuchowski NA, Zhou XH. Prospective studies of diagnostic test accuracy when disease prevalence is low. Biostatistics. 2002 Dec;3(4):477-92. doi: 10.1093/biostatistics/3.4.477.
• Jarvis KF, Kelley JB. Temporal dynamics of viral load and false negative rate influence the levels of testing necessary to combat COVID-19 spread. Sci Rep. 2021 Apr 28;11(1):9221. doi: 10.1038/s41598-021-88498-9.
• Parmar H, Montovano M, Banada P, Pentakota SR, Shiau S, Ma Z, Saibire K, Chopoorian A, O'Shaughnessy M, Hirsch M, Jain P, Demirdjian G, Karagueuzian M, Robin T, Salvati M, Patel B, Alland D, Xie YL. RT-PCR negative COVID-19. BMC Infect Dis. 2022 Feb 13;22(1):149. doi: 10.1186/s12879-022-07095-x.
• Pecoraro V, Negro A, Pirotti T, Trenti T. Estimate false-negative RT-PCR rates for SARS-CoV-2. A systematic review and meta-analysis. Eur J Clin Invest. 2022 Feb;52(2):e13706. doi: 10.1111/eci.13706. Epub 2021 Dec 5.
• Kanji JN, Zelyas N, MacDonald C, Pabbaraju K, Khan MN, Prasad A, Hu J, Diggle M, Berenger BM, Tipples G. False negative rate of COVID-19 PCR testing: a discordant testing analysis. Virol J. 2021 Jan 9;18(1):13. doi: 10.1186/s12985-021-01489-0.
• Phuphuakrat A, Pasomsub E, Srichatrapimuk S, Kirdlarp S, Suksatu A, Srisaowakarn C, Manopwisedjaroen S, Ludowyke N, Purwono PB, Priengprom T, Wongsa A, Thakkinstian A, Hongeng S, Malathum K, Thitithanyanont A, Tassaneetrithep B. Detectable Duration of Viable SARS-CoV-2, Total and Subgenomic SARS-CoV-2 RNA in Noncritically Ill COVID-19 Patients: a Prospective Cohort Study. Microbiol Spectr. 2022 Jun 29;10(3):e0050322. doi: 10.1128/spectrum.00503-22. Epub 2022 May 23.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): May 19, 2024
• Study Completion (Estimated): May 19, 2024

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; SARS-CoV-1; Rapid diagnostic test
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CBC-1051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 3M governs the policies, procedures and permissions. Submission of data to the FDA is probable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No