BD Veritor™ At-Home and BD Veritor™ Professional

Completed

Conditions studied: Upper Respiratory Infection

In brief

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.

Key facts

Study ID: NCT05352581
Run by: Becton, Dickinson and Company
People needed: 1146
Starts: 2022-07-21
Expected to finish: 2023-04-14
Last updated by the study team: 2023-06-07

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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.

Where it is running

CTMD Research — Coconut Creek, Florida, United States
CTMD Research — Palm Springs, Florida, United States
DBC Research — Pembroke Pines, Florida, United States
CTMD Reserarch — Asheville, North Carolina, United States
Kur Research - AFC Urgent Care — Easley, South Carolina, United States
Kur Research - AFC Urgent Care — Powdersville, South Carolina, United States
Kur Research - AFC Urgent Care — Seneca, South Carolina, United States
Kur Research - Complete Health Partners — Hendersonville, Tennessee, United States
Kur Research - Complete Health Partners — Nashville, Tennessee, United States
University of the Sunshine Coast — Sippy Downs, Queensland, Australia
Southern Clinical Trials - Totara — Auckland, New Zealand
Optimal Clinical Trials — Auckland, New Zealand
Southern Clinical Trials - Remuera — 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, New Zealand

Full record on ClinicalTrials.gov

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