COVID-19NCT05354115
Sample Collection for Evaluation of the Panbio™ COVID-19/ Flu A&B Rapid Panel.
A study testing Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid Panel in people with COVID-19 and Influenza A, run by Abbott Rapid Dx at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- COVID-19, Influenza A, Influenza Type B
- What is being tested?
- Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid Panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 676 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 22 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • Subject has had a nasal or a nasopharyngeal swab taken within the last 4 hours.
- Subject has active nose bleeds or acute facial injuries/trauma
- Subject has received a nasal vaccine (i.e., FluMist®) within the previous five (5) days.
- Subject is currently taking or has taken an antiviral medication-i.e., Amantadine, Rimantadine, Relenza® (Zanamivir), Tamiflu® (Oseltamivir Phosphate), and Flumadine®-for influenza within the previous thirty (30) days.
- Subject is currently enrolled in a study to evaluate an investigational drug.
- Subject is unwilling or unable to provide informed consent.
- Vulnerable populations as deemed inappropriate for study by the site's PI and/or reviewing REC.
Trial locations and contacts
1 site in 1 country.
United States1 site
Urgent Care Clinical Trials Easley
Easley, South Carolina, 29640
About this study
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.
Read the detailed description
A minimum of 665 male and female Subjects will be prospectively enrolled at multiple clinical sites. A minimum of 90 Flu A reference positive subjects, a minimum of 90 Flu B reference positive subjects and a minimum of 100 SARS-CoV-2 reference positive subjects will be enrolled. In addition, a minimum of 385 reference-negative subjects will be enrolled. In order to meet these minimum numbers it is anticipated that approximately 2000 subjects will be enrolled in total.
Subjects should be enrolled from point of care for this study. After informed consent has been obtained, operators will collect one nasal swab from both nostrils from each Subject. Every second subject will be asked to blow their nose first and this will be recorded.
Collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril.
The collected swab will be returned to a plastic tube (provided by the sponsor) and immediately (or within 15 minutes of collection) stored frozen at -80°C (or -20°C if -80°C storage is not available) for later testing with the Panbio™ Rapid Panel. Touching of the tube wall with the swab should be avoided. Nasal samples must be collected prior to the Nasopharyngeal sampling.
After the nasal sampling, the operators will collect a nasopharyngeal swab from one nostril of each subject. The NP swab will be returned to a plastic tube (provided by the sponsor) by study staff (touching the tube walls should be avoided) and immediately (or within 15 minutes of collection) stored frozen at -80°C (or -20°C if -80°C storage is not available) for later testing with the Panbio™ Rapid Panel.
A second nasopharyngeal swab, collected from the other nostril of each subject will be eluted in Universal Transport Media (UTM) and used for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2 as per local procedures. The remaining UTM will be labelled with Subject ID and immediately stored frozen at -80°C (or -20°C minimum). The RT-PCR methods used must have CE marking or FDA approval, with COVID-19 and Flu assay clearance for nasopharyngeal specimens and must be approved by the Sponsor. Nasopharyngeal sampling should be performed by trained healthcare professionals who routinely conduct nasopharyngeal sampling as part of their other standard of care and clinical duties.
All other aspects of the Subject's care will remain the same with no deviation from prescribed practice.
Each subject's demographic information, symptomology data, and professionally performed test result and questionnaire will be recorded on source documentation and transferred to an Electronic Data Capture system.
Samples collected in this study will be used for diagnostic research, product development and validation of the Panbio™ COVID-19/ Flu A\&B Rapid Panel by the study sponsor, Abbott.
- Conditions
- COVID-19, Influenza A, Influenza Type B
- Being tested
- Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid Panel
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid PanelDiagnostic test
Collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril. After the nasal sampling, the operators will collect two nasopharyngeal swab one from each nostril of each subject.
| Study group | Role | What they receive |
|---|---|---|
| Sampling | Other | 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. Receives: Diagnostic Test: Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal and Nasopharyngeal Sample Collection
The objective of this study is to collect nasal and nasopharyngeal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms. The collected samples will be sent to the sponsor (Abbott) or central laboratory for reference testing, diagnostic research, product development and validation of the Panbio™ COVID-19/ Flu A\&B Rapid Panel some of which will be used to support product registrations.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start14 Mar 2022
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Rapid Dx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354115
- Sponsor's protocol ID
- SDRD-H-002-P
- Status last verified
- Nov 2023
- First submitted
- 6 Apr 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sample Collection for Evaluation of the Panbio™ COVID-19/ Flu A&B Rapid Panel.
- ClinicalTrials.gov ID
- NCT05354115
- Acronym / sponsor ID
- SDRD-H-002-P
- Conditions
- COVID-19, Influenza A, Influenza Type B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- Abbott Rapid DxIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A minimum of 665 male and female Subjects will be prospectively enrolled at multiple clinical sites. A minimum of 90 Flu A reference positive subjects, a minimum of 90 Flu B reference positive subjects and a minimum of 100 SARS-CoV-2 reference positive subjects will be enrolled. In addition, a minimum of 385 reference-negative subjects will be enrolled. In order to meet these minimum numbers it is anticipated that approximately 2000 subjects will be enrolled in total.
Subjects should be enrolled from point of care for this study. After informed consent has been obtained, operators will collect one nasal swab from both nostrils from each Subject. Every second subject will be asked to blow their nose first and this will be recorded.
Collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril.
The collected swab will be returned to a plastic tube (provided by the sponsor) and immediately (or within 15 minutes of collection) stored frozen at -80°C (or -20°C if -80°C storage is not available) for later testing with the Panbio™ Rapid Panel. Touching of the tube wall with the swab should be avoided. Nasal samples must be collected prior to the Nasopharyngeal sampling.
After the nasal sampling, the operators will collect a nasopharyngeal swab from one nostril of each subject. The NP swab will be returned to a plastic tube (provided by the sponsor) by study staff (touching the tube walls should be avoided) and immediately (or within 15 minutes of collection) stored frozen at -80°C (or -20°C if -80°C storage is not available) for later testing with the Panbio™ Rapid Panel.
A second nasopharyngeal swab, collected from the other nostril of each subject will be eluted in Universal Transport Media (UTM) and used for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2 as per local procedures. The remaining UTM will be labelled with Subject ID and immediately stored frozen at -80°C (or -20°C minimum). The RT-PCR methods used must have CE marking or FDA approval, with COVID-19 and Flu assay clearance for nasopharyngeal specimens and must be approved by the Sponsor. Nasopharyngeal sampling should be performed by trained healthcare professionals who routinely conduct nasopharyngeal sampling as part of their other standard of care and clinical duties.
All other aspects of the Subject's care will remain the same with no deviation from prescribed practice.
Each subject's demographic information, symptomology data, and professionally performed test result and questionnaire will be recorded on source documentation and transferred to an Electronic Data Capture system.
Samples collected in this study will be used for diagnostic research, product development and validation of the Panbio™ COVID-19/ Flu A\&B Rapid Panel by the study sponsor, Abbott.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sampling | Other | Diagnostic Test: Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid PanelEvery 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. |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- • Subject has had a nasal or a nasopharyngeal swab taken within the last 4 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid PanelCollection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril. After the nasal sampling, the operators will collect two nasopharyngeal swab one from each nostril of each subject. | Diagnostic test | Sampling |
Primary outcome
Nasal and Nasopharyngeal Sample Collection
Time frame: 6 months
The objective of this study is to collect nasal and nasopharyngeal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms. The collected samples will be sent to the sponsor (Abbott) or central laboratory for reference testing, diagnostic research, product development and validation of the Panbio™ COVID-19/ Flu A\&B Rapid Panel some of which will be used to support product registrations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid Panel in people with COVID-19 and Influenza A, run by Abbott Rapid Dx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal and Nasopharyngeal Sample Collection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.