Upper Respiratory InfectionNCT05352581
BD Veritor™ At-Home and BD Veritor™ Professional
An observational study of Upper Respiratory Infection, run by Becton, Dickinson and Company at 17 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Upper Respiratory Infection
- What is being tested?
- BD Veritor At-Home and BD Veritor Professional
- How many people
- 1,146 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 21 Jul 2022to 14 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals presenting with symptoms of acute respiratory illness
Who may be able to join
- 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
Show all 18Show fewer
- 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)
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States9 sites
CTMD Reserarch
Asheville, North Carolina, 28804
CTMD Research
Coconut Creek, Florida, 33063
Kur Research - AFC Urgent Care
Easley, South Carolina, 29640
Kur Research - Complete Health Partners
Hendersonville, Tennessee, 37075
Kur Research - Complete Health Partners
Nashville, Tennessee, 37209
CTMD Research
Palm Springs, Florida, 33406
DBC Research
Pembroke Pines, Florida, 33029
Kur Research - AFC Urgent Care
Powdersville, South Carolina, 29611
Kur Research - AFC Urgent Care
Seneca, South Carolina, 29678
New Zealand7 sites
Southern Clinical Trials - Totara
Auckland, 0600
Optimal Clinical Trials
Auckland, 1010
Southern Clinical Trials - Remuera
Auckland, 1050
Lakeland Clinical Trials - Waikato
Hamilton, 3200
Southern Clinical Trials - Tasman
Nelson, 7011
Silverdale Medical Ltd
Silverdale, 0932
Southern Clinical Trials - Wellington
Upper Hutt, 5018
Australia1 site
University of the Sunshine Coast
Sippy Downs, Queensland, 4556
About this study
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
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.
Read the detailed 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.
- Conditions
- Upper Respiratory Infection
- Being tested
- BD Veritor At-Home, BD Veritor Professional
- Keywords
- SARS COV 2, Influenza
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD Veritor At-HomeDiagnostic test
BD Veritor At-Home rapid self testing
BD Veritor ProfessionalDiagnostic test
BD Veritor Professional rapid test
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: BD Veritor At-Home; Diagnostic Test: BD Veritor Professional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after specimen collection
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
Measured: Immediately after specimen collection
Secondary outcomes (2)
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
Measured: Within 30 minutes of test completion
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
Measured: Within 1 day of first device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start21 Jul 2022
- Primary completion9 Mar 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352581
- Sponsor's protocol ID
- IDS-VERTPPGEN2
- Status last verified
- Jun 2023
- First submitted
- 11 Apr 2022
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05352581
- Acronym / sponsor ID
- IDS-VERTPPGEN2
- Conditions
- Upper Respiratory Infection
- Keywords
- SARS COV 2, Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,146 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BD Veritor | – | Diagnostic Test: BD Veritor At-Home, Diagnostic Test: BD Veritor ProfessionalEach 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) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals presenting with symptoms of acute respiratory illness
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD Veritor At-HomeBD Veritor At-Home rapid self testing | Diagnostic test | BD Veritor |
| BD Veritor ProfessionalBD Veritor Professional rapid test | Diagnostic test | BD Veritor |
Primary outcome
Diagnostic accuracy of the BD Veritor At-Home Assay
Time frame: Immediately after specimen collection
Positive percent agreement of the BD Veritor At-Home Assay compared to an FDA cleared/approved RT-PCR Assay
Diagnostic accuracy of the BD Veritor Professional Assay
Time frame: Immediately after specimen collection
Positive percent agreement of the BD Professional Assay compared to an FDA cleared/approved RT-PCR Assay
2 secondary outcomes
Ease of Use of the BD Veritor At-Home Assay
Time frame: Within 30 minutes of test completion
Ease of Use of the BD Professional Assay
Time frame: Within 1 day of first device use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
Related trials for Upper Respiratory Infection
Not yet recruitingPhase 4
SPARK Study - Sympathetic Periarterial Radial Block in Healthy Volunteers
Healthy Volunteers, Sympathetic Activity
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Respiratory Infection, run by Becton, Dickinson and Company at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the BD Veritor At-Home Assay (time frame: Immediately after specimen collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.