Status:
COMPLETED
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel to Support Home Use
Lead Sponsor:
Abbott Rapid Dx
Conditions:
COVID-19
Influenza A
Eligibility:
All Genders
2+ years
Phase:
NA
Brief Summary
This study is designed to demonstrate the performance and usability of the the Panbio™ COVID-19/Flu A\&B Panel Self Test in the hands of patients/lay-users. Nasal swabs will be self-collected by subje...
Detailed Description
The total number of anterior nasal swabs collected from each consented Participant is two (2). Participants at least two (2) years of age meeting eligibility criteria will be enrolled. The order of n...
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 seven (7) days of symptom onset, and
- Participant is experiencing two or more of the following symptoms
- Fever of \>100.0°F/ 37.8°C
- 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
- Nausea or vomiting
- Diarrhea
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 received a nasal spray or mist Influenza vaccine (i.e. FluMist) within the last 30 days
- Participant has tested positive for COVID-19 within the last 45 days (excluding test results received after current onset of symptoms)
- 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, convalescent plasma therapy, monoclonal antibody treatment (mAb), Remdesivir, long-acting antibody (LAAB) treatment (Evusheld)
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2024
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT06124638
Start Date
December 4 2023
End Date
April 3 2024
Last Update
August 19 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Cahaba Research Inc
Pelham, Alabama, United States, 35124
2
Maimonides Medical Center
Brooklyn, New York, United States, 11219