Study Results
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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UNKNOWN
330 participants
OBSERVATIONAL
2023-07-10
2024-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
5 Years
ALL
Yes
Sponsors
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3M
INDUSTRY
Biomedical Advanced Research and Development Authority
FED
JPRA Enterprises, LLC
UNKNOWN
Cantor BioConnect, Inc.
NETWORK
Responsible Party
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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
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
Countries
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Central Contacts
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Facility Contacts
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Robert Azurin, MD
Role: primary
Ausberto Hidalgo, MD
Role: primary
David Benson, MD
Role: primary
Hermes Hernandez, MD
Role: primary
Francisco Ortiz, MD
Role: primary
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.
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.
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.
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.
Other Identifiers
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CBC-1051
Identifier Type: -
Identifier Source: org_study_id
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