Status:
COMPLETED
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel
Lead Sponsor:
Abbott Rapid Dx
Conditions:
COVID-19
Influenza A
Eligibility:
All Genders
2+ years
Phase:
NA
Brief Summary
The study is designed as a prospective, multicentric, clinical study to investigate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Panbio™ COVID-19/Flu A\&B Panel usi...
Detailed Description
Approximately 2,000 symptomatic Participants to achieve at least 80 COVID-19 PCR confirmed positives, 80 Flu A PCR confirmed positives, 80 Flu B PCR confirmed positives, and 500 COVID-19 and Influenza...
Eligibility Criteria
Inclusion
- Participant is suspected of acute viral respiratory infection by a healthcare professional, and
- Participant is age two (2) years or older, 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 enrollment
- 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 :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2024
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT06127108
Start Date
November 14 2023
End Date
February 2 2024
Last Update
April 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Advanced Pediatrics
Vienna, Virginia, United States, 22180