Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05352581




Registration number
NCT05352581
Ethics application status
Date submitted
11/04/2022
Date registered
29/04/2022
Date last updated
7/06/2023

Titles & IDs
Public title
BD Veritor™ At-Home and BD Veritor™ Professional
Scientific 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
Secondary ID [1] 0 0
IDS-VERTPPGEN2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Respiratory Infection 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - BD Veritor At-Home
Diagnosis / Prognosis - BD Veritor Professional

BD Veritor - Each subject will:

Self collect a nasal swab for testing on the BD Veritor At-home test (test device) Have a clinician collected nasal swab for testing on the BD Veritor Professional Test (test device) Have a clinical collected nasal swab for testing on an FDA cleared/approved RT-PCR assay (control device)


Diagnosis / Prognosis: BD Veritor At-Home
BD Veritor At-Home rapid self testing

Diagnosis / Prognosis: BD Veritor Professional
BD Veritor Professional rapid test
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic accuracy of the BD Veritor At-Home Assay
Timepoint [1] 0 0
Immediately after specimen collection
Primary outcome [2] 0 0
Diagnostic accuracy of the BD Veritor Professional Assay
Timepoint [2] 0 0
Immediately after specimen collection
Secondary outcome [1] 0 0
Ease of Use of the BD Veritor At-Home Assay
Timepoint [1] 0 0
Within 30 minutes of test completion
Secondary outcome [2] 0 0
Ease of Use of the BD Professional Assay
Timepoint [2] 0 0
Within 1 day of first device use

Eligibility
Key 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)
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/04/2023
Sample size
Target
Accrual to date
Final
1146
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment postcode(s) [1] 0 0
4556 - Sippy Downs
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
South Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
New Zealand
State/province [6] 0 0
Hamilton
Country [7] 0 0
New Zealand
State/province [7] 0 0
Nelson
Country [8] 0 0
New Zealand
State/province [8] 0 0
Silverdale
Country [9] 0 0
New Zealand
State/province [9] 0 0
Upper Hutt

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Becton, Dickinson and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05352581
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05352581