BD Veritor™ At-Home and BD Veritor™ Professional

Upper Respiratory Infection Clinical Trial

Official title:

Clinical Evaluation of The BD Veritor™ At-Home COVID-19 & Flu Test and BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B Assay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352581
• Other study ID #: IDS-VERTPPGEN2
• Status: Completed
• Start date: July 21, 2022
• Est. completion date: April 14, 2023

Study information

• Verified date: June 2023
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The BD Veritor™ System is a rapid test that is testing for both COVID-19 and for Influenza This study will try to determine if the BD Veritor™ system can assist in the diagnosis of someone who has upper respiratory infection symptoms. There is both an At-Home self test and test completed by a health care professional that will be completed during this study.

Description:

This is a prospective, multi-country, multicenter, comparative study to assess the performance of the BD Veritor™ At-Home SARS-CoV-2 & Flu A+B test and the BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B (Professional use) compared to an FDA approved Flu A/B reference assay (RT-PCR) and FDA authorized molecular SARS-CoV-2 comparator reference method assays.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1146
• Est. completion date: April 14, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• 1. Participants symptomatic of an acute respiratory illness within 7 DOSO

• 2. =2 years of age at the time of study participation

• 3. Symptomatic subjects with

• a. Any one of the following symptoms (with or without additional symptoms):

• i. Fever

• 1. Oral/temporal artery: =100.4 °F / =38.0 °C

• 2. Rectal/Ear: =101.2 °F / =38.5 °C

• ii. Cough

• iii. Malaise (fatigue/extreme tiredness)

• b. Or two of the following symptoms:

• i. Sore throat,

• ii. Shortness of breath/difficult breathing

• iii. Rhinorrhea (runny or stuffy nose),

• iv. Myalgia,

• v. Headache,

• vi. Sneezing,

• vii. New loss of taste or smell,

• viii. One or more GI symptoms (nausea, vomiting, diarrhea)

Exclusion Criteria:

• 1. Participants currently undergoing treatment and/or within the past thirty (30) days of the study, with medication to treat novel Coronavirus SARS-CoV-2 viral infections, which may include but is not limited to Remdesivir (Veklury)

• 2. Participants receiving convalescent plasma therapy for SARS-CoV-2.

• 3. Participants who have received antiviral medications for influenza within the previous 30 days.

• 4. Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit.

• 5. The participant is currently receiving or has received within the past thirty (30) days of the study visit, an experimental biologic or drug including either treatment or therapy.

• 6. Participants who have been previously enrolled in the study.

• 7. History of frequent or difficult to control nosebleeds within the last fourteen (14) days.

• 8. Participants who have tested positive for Flu A/B or SARS-CoV-2 within the last 28 days (excluding the day of enrollment in the study).

Exclusion criteria for the participation in the At-Home portion of the study would include all of the criteria previously listed and include the following

• 1. Participants without the ability to read or write in the English Language

• 2. Participants with prior medical or laboratory training.

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Infection

Intervention

Diagnostic Test:
• BD Veritor At-Home
BD Veritor At-Home rapid self testing
• BD Veritor Professional
BD Veritor Professional rapid test

Locations

Country	Name	City	State
Australia	University of the Sunshine Coast	Sippy Downs	Queensland
New Zealand	Optimal Clinical Trials	Auckland
New Zealand	Southern Clinical Trials - Remuera	Auckland
New Zealand	Southern Clinical Trials - Totara	Auckland
New Zealand	Lakeland Clinical Trials - Waikato	Hamilton
New Zealand	Southern Clinical Trials - Tasman	Nelson
New Zealand	Silverdale Medical Ltd	Silverdale
New Zealand	Southern Clinical Trials - Wellington	Upper Hutt
United States	CTMD Reserarch	Asheville	North Carolina
United States	CTMD Research	Coconut Creek	Florida
United States	Kur Research - AFC Urgent Care	Easley	South Carolina
United States	Kur Research - Complete Health Partners	Hendersonville	Tennessee
United States	Kur Research - Complete Health Partners	Nashville	Tennessee
United States	CTMD Research	Palm Springs	Florida
United States	DBC Research	Pembroke Pines	Florida
United States	Kur Research - AFC Urgent Care	Powdersville	South Carolina
United States	Kur Research - AFC Urgent Care	Seneca	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of the BD Veritor At-Home Assay	Positive percent agreement of the BD Veritor At-Home Assay compared to an FDA cleared/approved RT-PCR Assay	Immediately after specimen collection
Primary	Diagnostic accuracy of the BD Veritor Professional Assay	Positive percent agreement of the BD Professional Assay compared to an FDA cleared/approved RT-PCR Assay	Immediately after specimen collection
Secondary	Ease of Use of the BD Veritor At-Home Assay	Subject completed 5-Point Likert scale rating ease of use where 1 indicates difficult and 5 indicates easy	Within 30 minutes of test completion
Secondary	Ease of Use of the BD Professional Assay	Clinician completed 5-Point Likert scale rating ease of use where 1 indicates difficult and 5 indicates easy	Within 1 day of first device use