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NCT04368260 · ClinicalTrials.gov registry record · NA
Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic
A NA study of Covid19, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04368260 is a NA study of Covid19 that has completed, run by University of Virginia. The registered enrollment target is 40 participants, below the 2,702-participant average among 94 other Covid19 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04368260, a NA study of Covid19, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The SARS-CoV-2 pandemic has resulted in an international shortage of the nasopharyngeal (NP) swabs used to collect sample for virological testing. This shortage has become a crisis as testing capacity is growing, and threatens to become the bottleneck at University of Virginia Health System and in the Commonwealth of Virginia, as it already is in other testing centers. To resolve this crisis, a team in the Clinical Microbiology Laboratories at University of Virginia Medical Center has been working closely with biomedical engineers in the University of Virginia (UVA), School of Engineering and with high volume domestic manufacturers developing injection molded polypropylene flocked nylon NP swab. This prototype will be tested for non-inferiority relative to existing, already validated NP swabs ("control swab") for purposes of molecular microbiology: i.e. the polymerase chain reaction (PCR) tests used for virological testing for SARS-CoV-2. Specifically, the nasopharynx of patients with Covid-19 and patients under investigation (PUI) for Covid-19, the disease caused by SARS-CoV-2, will be swabbed using a prototype swab and a control swab (the standard of care swab), and test for concordance of SARS-CoV-2. In all cases the swab will be transported in validated FDA cleared viral transport medium (VTM) as per standard operating procedure at University of Virginia Medical Center.
Conditions Studied
Interventions
- DEVICE Control swab
- DEVICE Prototype swab
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-04-24 |
| Est. Completion | 2020-08-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04368260
The ClinicalTrials.gov registry entry for NCT04368260 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,702-participant average among 94 other Covid19 trials with a reported enrollment target (99% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Covid19 appearing as the primary indexed condition, and to 2 interventions - of which Control swab is the first listed.
NCT04368260 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT04368260 about?
NCT04368260 is a clinical study titled "Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic". The SARS-CoV-2 pandemic has resulted in an international shortage of the nasopharyngeal (NP) swabs used to collect sample for virological testing. This shortage has become a crisis as testing capacity is growing, and threatens to become the bottleneck at University of Virginia Health System and in t...
What is the current status of trial NCT04368260?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2020-04-24. Estimated completion is 2020-08-01.
What conditions does trial NCT04368260 study?
This clinical trial studies the following conditions: Covid19.
What interventions are being tested in trial NCT04368260?
The interventions under investigation include: Control swab (DEVICE), Prototype swab (DEVICE).
Who is sponsoring clinical trial NCT04368260?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04368260 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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