Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1146 participants
OBSERVATIONAL
2022-07-21
2023-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
BD Veritor At-Home
BD Veritor At-Home rapid self testing
BD Veritor Professional
BD Veritor Professional rapid test
Interventions
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BD Veritor At-Home
BD Veritor At-Home rapid self testing
BD Veritor Professional
BD Veritor Professional rapid test
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
* 1\. Participants without the ability to read or write in the English Language
* 2\. Participants with prior medical or laboratory training.
2 Years
ALL
No
Sponsors
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Becton, Dickinson and Company
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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IDS-VERTPPGEN2
Identifier Type: -
Identifier Source: org_study_id
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