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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