Bioaerosol Sampling Device (BSD) Clinical Study

Study Overview
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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.

Official Title
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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

Conditions
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COVID-19

Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Rapid diagnostic test, SARS-CoV-2, SARS-CoV-1