Status:
NOT_YET_RECRUITING
Clinical Feasibility of the BinaxNOW™ COVID-19/Flu A&B Combo in the Southern Hemisphere
Lead Sponsor:
Abbott Rapid Dx
Conditions:
Influenza Type A
Influenza Type B
Eligibility:
All Genders
2+ years
Phase:
NA
Brief Summary
The study is designed as a clinical feasibility, to investigate the positive and negative percent agreement (PPA and NPA) of the BinaxNOW™ COVID-19/Flu A\&B Combo against a highly sensitive PCR method...
Detailed Description
Approximately 700 symptomatic participants will be enrolled to achieve at least 61 COVID PCR positive, 45 Flu A PCR positives, 30 Flu B PCR positives and 301 COVID and Influenza PCR negatives. The to...
Eligibility Criteria
Inclusion
- Participant is at least two (2) years of age, AND Participant is suspected of acute viral respiratory infection by a healthcare professional, AND
- Participant is within five (5) days of symptom onset, AND
- Participant is experiencing two or more of the following symptoms:
- Fever of \>100.0°F/ 37.8°C or chills, Cough, Fatigue, New loss of taste or smell, Congestion or runny nose, Shortness of breath or difficulty breathing, Sore throat, Muscle or body aches, Headache
- The Participant and/or legally authorized representative is willing to undergo the informed consent/Assent process prior to study participation. A minor will need the documented consent of their parent or legal guardian unless the site has an HREC waiver for parental consent for minors.
Exclusion
- Participant is currently enrolled in a study to evaluate an investigational drug or experimental treatment
- Participants with an active nosebleed
- Participant has undergone a nasal wash or nasal aspirate procedure on day of enrolment
- Participant has tested positive for COVID-19 within the last 45 days
- Participant has received a nasal vaccine (i.e. FluMist®) within the past 30 days.
- Participant has received antiviral medications for Influenza (Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir) in the previous 45 days.
- Participant has received medication or treatment for COVID-19 infection in the last 45 days (including antivirals (such as Paxlovid), convalescent plasma therapy, monoclonal antibody treatment (mAb), Remdesivir, long-acting antibody (LAAB) treatment (Evusheld)
- Participant is unable to meet all inclusion criteria as listed above
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06928129
Start Date
June 30 2025
End Date
November 1 2025
Last Update
April 15 2025
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