Clinical trial NCT05352581: BD Veritor™ At-Home and BD Veritor™ Professional
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Respiratory Infection
Keywords: SARS COV 2
Influenza
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 1146
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals presenting with symptoms of acute respiratory illness

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic accuracy of the BD Veritor At-Home Assay
timeFrame: Immediately after specimen collection
measure: Diagnostic accuracy of the BD Veritor Professional Assay
timeFrame: Immediately after specimen collection
Secondary outcomes:
measure: Ease of Use of the BD Veritor At-Home Assay
timeFrame: Within 30 minutes of test completion
measure: Ease of Use of the BD Professional Assay
timeFrame: Within 1 day of first device use
Other outcomes:
Locations:
city: Coconut Creek
country: United States
facility: CTMD Research
state: Florida
city: Palm Springs
country: United States
facility: CTMD Research
state: Florida
city: Pembroke Pines
country: United States
facility: DBC Research
state: Florida
city: Asheville
country: United States
facility: CTMD Reserarch
state: North Carolina
city: Easley
country: United States
facility: Kur Research - AFC Urgent Care
state: South Carolina
city: Powdersville
country: United States
facility: Kur Research - AFC Urgent Care
state: South Carolina
city: Seneca
country: United States
facility: Kur Research - AFC Urgent Care
state: South Carolina
city: Hendersonville
country: United States
facility: Kur Research - Complete Health Partners
state: Tennessee
city: Nashville
country: United States
facility: Kur Research - Complete Health Partners
state: Tennessee
city: Sippy Downs
country: Australia
facility: University of the Sunshine Coast
state: Queensland
city: Auckland
country: New Zealand
facility: Southern Clinical Trials - Totara
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Auckland
country: New Zealand
facility: Southern Clinical Trials - Remuera
city: Hamilton
country: New Zealand
facility: Lakeland Clinical Trials - Waikato
city: Nelson
country: New Zealand
facility: Southern Clinical Trials - Tasman
city: Silverdale
country: New Zealand
facility: Silverdale Medical Ltd
city: Upper Hutt
country: New Zealand
facility: Southern Clinical Trials - Wellington
Study officials:
References: