Clinical trial NCT04368260: Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic
Official title: Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID19
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The primary objective of this study is to determine whether the newly designed nasopharyngeal swabs perform acceptably compared to standard swabs.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Individuals presenting to the site for clinical care will be evaluated for clinical screening for Covid-19 testing or other respiratory infection testing.
* Individuals felt identified clinically as needing Covid-19 testing may be approached for study participation.
* Individuals already under clinical care that have tested positive for Covid-19 will be approached for study participation.
* Volunteer health care workers who have approached the Principal Investigator

Exclusion Criteria:

* Known thrombocytopenia of \<50,000 platelets/μl (risk of mild bleeding).
* Individuals presenting with an anatomically altered nasal cavity.
* Pregnant (self-reported)
* No other patients will be specifically excluded.

Primary outcomes:
measure: Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result
timeFrame: at time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Amy Mathers, MD
role: PRINCIPAL_INVESTIGATOR
References: