Bioaerosol Sampling Device (BSD) Clinical Study

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047067
• Other study ID #: CBC-1051
• Status: Recruiting
• Start date: July 10, 2023
• Est. completion date: May 19, 2024

Study information

• Verified date: September 2023
• Source: Cantor BioConnect, Inc.
• Contact: Study Cooridnator
• Phone: (619) 635-5843
• Email: emerald[@]cantorbioconnect.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: May 19, 2024
• Est. primary completion date: May 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
United States	Alfa Medical Research	Hollywood	Florida
United States	HDH Research	Houston	Texas
United States	HDH Research	Houston	Texas
United States	HDH Research	Humble	Texas
United States	Alfa Medical Urgent Care	Pembroke Pines	Florida
United States	JPRA Enterprise, LLC	S. Gate	California

Sponsors (4)

Lead Sponsor	Collaborator
Cantor BioConnect, Inc.	3M, Biomedical Advanced Research and Development Authority, JPRA Enterprises, LLC

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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