Bioaerosol Sampling Device (BSD) Clinical Study

NCT ID: NCT06047067

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-05-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Biomedical Advanced Research and Development Authority

FED

Sponsor Role collaborator

JPRA Enterprises, LLC

UNKNOWN

Sponsor Role collaborator

Cantor BioConnect, Inc.

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Azurin, MD

Role: PRINCIPAL_INVESTIGATOR

JPRA Enterprises, LLC

Locations

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JPRA Enterprise, LLC

South Gate, California, United States

Site Status RECRUITING

Alfa Medical Research

Hollywood, Florida, United States

Site Status RECRUITING

Alfa Medical Urgent Care

Pembroke Pines, Florida, United States

Site Status RECRUITING

HDH Research

Houston, Texas, United States

Site Status RECRUITING

HDH Research

Houston, Texas, United States

Site Status RECRUITING

HDH Research

Humble, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Cooridnator

Role: CONTACT

(619) 635-5843

Facility Contacts

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Robert Azurin, MD

Role: primary

562-547-1799

Ausberto Hidalgo, MD

Role: primary

754-263-3626

David Benson, MD

Role: primary

Hermes Hernandez, MD

Role: primary

Francisco Ortiz, MD

Role: primary

346-282-4426

Damari Duarte, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 32087114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32125371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33948037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34625778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12933593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15287083 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33911131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35152885 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34741305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33422083 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35604133 (View on PubMed)

Other Identifiers

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CBC-1051

Identifier Type: -

Identifier Source: org_study_id

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