Status:
COMPLETED
BD Veritor™ At-Home and BD Veritor™ Professional
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Upper Respiratory Infection
Eligibility:
All Genders
2+ years
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 upp...
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 S...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 14 2023
Estimated Enrollment :
1146 Patients enrolled
Trial Details
Trial ID
NCT05352581
Start Date
July 21 2022
End Date
April 14 2023
Last Update
June 7 2023
Active Locations (17)
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1
CTMD Research
Coconut Creek, Florida, United States, 33063
2
CTMD Research
Palm Springs, Florida, United States, 33406
3
DBC Research
Pembroke Pines, Florida, United States, 33029
4
CTMD Reserarch
Asheville, North Carolina, United States, 28804