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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects >14 years of age who are able and willing to provide written informed consent, and deemed suitable for nasopharyngeal sampling in accordance with local procedures, suspected of having a respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms, and presenting at least two of the following symptoms: fever, headache, extreme tiredness, dry cough, sore throat, runny or stuffy nose, muscle aches, loss of smell, loss of taste or shortness of breath, will be prospectively enrolled.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This study is designed as a prospective, multicentric, sample collection study. The collected samples will be used for diagnostic research, product development and validation of the Panbio™ COVID-19/ Flu A&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen (H1N1 and H3N2), and Influenza B antigen in human nasal and nasopharyngeal swabs by the study sponsor, Abbott.
Eligible Conditions
- COVID-19
- Coronavirus
- Flu
- Flu Type B
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nasal and Nasopharyngeal Sample Collection
Trial Design
1Treatment groups
Experimental Treatment
Group I: SamplingExperimental Treatment1 Intervention
Every second participant will be instructed to blow their nose. Study personnel will then collect one nasal swab from both nostrils and two NP swabs, one from each nostril from each participant.
Nasal samples must always be collected prior to the Nasopharyngeal sampling. A minimum of 90 Flu A positive subjects, a minimum of 90 Flu B positive subjects and a minimum of 100 SARS-CoV-2 positive subjects will be enrolled. In addition, a minimum of 385 negative subjects will be enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid Panel
2022
N/A
~680
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Who is running the clinical trial?
Abbott Rapid DxLead Sponsor
5 Previous Clinical Trials
7,055 Total Patients Enrolled
4 Trials studying COVID-19
6,032 Patients Enrolled for COVID-19
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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