Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic

NCT04368260 | Completed Results FDA Device

• 1 other identifier: HSR200127
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID19

Outcome Measures

Primary Outcomes (1)

• Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result

  Both the prototype and control nasopharyngeal swabs will be utilized in each subject. The rate of agreement between the swabs will be determined by the number of subjects for which both swabs provide the same COVID-19 PCR result.

  at time of enrollment

Study Arms (2)

Control swab

ACTIVE COMPARATOR

FDA cleared swab

Device: Control swab

Prototype swab

EXPERIMENTAL

Injection molded polypropylene flocked nylon NP swab

Device: Prototype swab

Interventions

Control swab DEVICE

FDA-cleared nasopharyngeal swab

Control swab

Prototype swab DEVICE

Injection molded polypropylene flocked nylon nasopharyngeal swab

Prototype swab

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Amy Mathers
• Organization: University of Virginia

ajm5b@virginia.edu

434-924-9678

Study Officials

• Amy Mathers, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine, Infectious Disease

Model Details: The primary objective of this study is to determine whether the newly designed nasopharyngeal swabs perform acceptably compared to standard swabs.

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 29, 2020
• Study Start: April 24, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: February 17, 2022
• Results First Posted: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after publication
• Access Criteria: Requests to made to Principal Investigator

Locations

US (1)