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COVID-19NCT06047067

Bioaerosol Sampling Device (BSD) Clinical Study

An observational study of COVID-19, run by Cantor BioConnect, Inc. at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
How many people
330 participants
Where
6 sitesUnited States
Study dates
10 Jul 2023to 19 May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

Study Cooridnator contact

(619) 635-5843

emerald@cantorbioconnect.com

6 sites in 1 country

United States6 sites, 6 recruiting

  • Alfa Medical Research

    Hollywood, Florida, 33204

    Ausberto Hidalgo, MD, 754-263-3626

    Recruiting

  • HDH Research

    Houston, Texas, 77009

    Hermes Hernandez, MD

    Recruiting

  • HDH Research

    Houston, Texas, 77022

    Francisco Ortiz, MD, 346-282-4426

    Recruiting

  • HDH Research

    Humble, Texas, 77338

    Damari Duarte, MD

    Recruiting

  • Alfa Medical Urgent Care

    Pembroke Pines, Florida, 33029

    David Benson, MD

    Recruiting

  • JPRA Enterprise, LLC

    South Gate, California, 90280

    Robert Azurin, MD, 562-547-1799

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
COVID-19
Keywords
COVID-19, Rapid diagnostic test, SARS-CoV-2, SARS-CoV-1
Medical subject headings
COVID-19, Severe Acute Respiratory Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (1)

  1. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start10 Jul 2023
  3. Primary completion19 May 2024 (estimated)
  4. Study completion19 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047067
Sponsor's protocol ID
CBC-1051
Status last verified
Sep 2023
First submitted
14 Sep 2023
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 3M governs the policies, procedures and permissions. Submission of data to the FDA is probable.

Publications

  • 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.

    PubMed 32087114

  • 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.

    PubMed 32125371

  • 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.

    PubMed 33948037

  • 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.

    PubMed 34625778

  • 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.

    PubMed 12933593

  • 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.

    PubMed 15287083

  • 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.

    PubMed 33911131

  • 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.

    PubMed 35152885

  • 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.

    PubMed 34741305

  • 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.

    PubMed 33422083

  • 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.

    PubMed 35604133

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Cantor BioConnect, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Study Cooridnator ((619) 635-5843, emerald@cantorbioconnect.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06047067, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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Bioaerosol Sampling Device (BSD) Clinical Study | AzTrials