COVID-19NCT05800158
Butterfly - Clinical Performance Study
An observational study of COVID-19 and Coronavirus Infections, run by Thermo Fisher Scientific, Inc at 11 sites in United States.
Trial summary
This prospective clinical performance study is a non-interventional, multi-center study to evaluate the assay performance of the COVID-19 test using upper respiratory specimens. Prospectively collected nasopharyngeal and anterior nasal swabs will be collected from each participant recruited in the study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Coronavirus Infections
- What is being tested?
- Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit
- How many people
- 1,076 participants
- Where
- 11 sitesUnited States
- Study dates
- 12 Apr 2023to 10 Aug 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be composed of participants suspected of COVID-19. After a subject is determined eligible for study participation (met inclusion criteria and did not meet exclusion criteria) and has completed the institutional review board (IRB)-approved informed consent form process (or assent, as age appropriate), the subject is enrolled into the study.
Who may be able to join
- Participants of all ages must meet the following inclusion criteria to be eligible for participation in the study:
- Ability to provide informed consent or assent (as age-appropriate). Stated willingness and ability to comply with the study procedures including nasopharyngeal and anterior nasal swab collection.
- Individuals with at least one of the following COVID-19 symptoms:
- fever or chills
- congestion or runny nose
- headache or fatigue
Show all 9Show fewer
- muscle or body aches
- new loss of taste or smell c. a new or worsening cough or sore throat d. shortness of breath or difficulty breathing e. decrease in appetite, nausea, vomiting, diarrhea.
- Subjects suspected of having COVID-19 symptoms for seven (7) or fewer days.
Who cannot join
- Participants meeting the following criterion will be excluded from the study:
- Subjects suspected of having COVID-19 symptoms for greater than seven (7) days.
- Subjects who have provided upper respiratory tract samples for other clinical studies within twenty-four (24) hours
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
ClinSearch
Chattanooga, Tennessee, 37421
KUR Research at AFC Urgent Care
Easley, South Carolina, 29640
Multi Specialty Research Associates
Lake City, Florida, 32055
Clinical Research Center of Nevada
Las Vegas, Nevada, 89106
KUR Research at Exer Urgent Care - Manhattan Beach
Manhattan Beach, California, 90266
KUR Research at CityDoc Urgent Care
McKinney, Texas, 75204
D&H National Research Centers
Miami, Florida, 33155
KUR Research at AFC Urgent Care
Powdersville, South Carolina, 29611
KUR Research at Exer Urgent Care - Redondo Beach
Redondo Beach, California, 90277
Medical Center for Clinical Research
San Diego, California, 92120
KUR Research at AFC Urgent Care
The Bronx, New York, 10465
About this study
Official title: Butterfly (IVD -TAQPATH V1 510K) - Clinical Performance Study Protocol - PRJ0003622
This prospective clinical performance study is a non-interventional, multi-center study to evaluate the assay performance of the COVID-19 test using upper respiratory specimens. Prospectively collected nasopharyngeal and anterior nasal swabs will be collected from each participant recruited in the study.
Read the detailed description
The Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (referred to as "COVID-19 test") aims to develop a reverse transcription, real-time polymerase chain reaction (RT-qPCR) test for the qualitative detection of SARS-CoV-2.
The purpose of this study is to evaluate the clinical performance of the TaqPath™ COVID-19 Diagnostic PCR Kit (COVID-19 test) in nasopharyngeal swabs and anterior nasal swabs from symptomatic individuals suspected of COVID-19 by their health care provider.
A composite comparator approach will be used to evaluate the performance of the COVID-19 test which includes the use of three highly sensitive SARS-CoV-2 molecular assays as comparators. Clinical calls will be compared between COVID-19 test and the three composite comparators. The third comparator assay will only be used to test samples that show discrepant clinical calls between the first two comparator methods, for a two-out-of-three result interpretation. The Clinical Performance Study Protocol (CPS Protocol) outlines the clinical sample collection and testing protocols which will be used to satisfy the FDA 510(k) study requirements in the US.
- Conditions
- COVID-19, Coronavirus Infections
- Being tested
- Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitDiagnostic test
A reverse transcription, real-time polymerase chain reaction (RT-qPCR) test for the qualitative detection of SARS-CoV-2.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 | Nasopharyngeal and anterior nasal swabs collected from symptomatic individuals suspected of COVID-19 by their health care provider. Receives: Diagnostic Test: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance evaluation of the COVID-19 test
Clinical performance evaluation of the COVID-19 test using a composite comparator approach with upper respiratory specimens to meet PPA and NPA requirements.
Measured: Between April 2023 and August 2023
Identification of adverse events
Identify any adverse events or complications associated with the COVID-19 test
Measured: Between April 2023 and August 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start12 Apr 2023
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thermo Fisher Scientific, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800158
- Sponsor's protocol ID
- PCP0131832
- Status last verified
- Oct 2023
- First submitted
- 23 Mar 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Butterfly (IVD -TAQPATH V1 510K) - Clinical Performance Study Protocol - PRJ0003622
- ClinicalTrials.gov ID
- NCT05800158
- Acronym / sponsor ID
- PCP0131832
- Conditions
- COVID-19, Coronavirus Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,076 participants (actual)
- Lead sponsor
- Thermo Fisher Scientific, IncIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 5 Apr 2023 (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 prospective clinical performance study is a non-interventional, multi-center study to evaluate the assay performance of the COVID-19 test using upper respiratory specimens. Prospectively collected nasopharyngeal and anterior nasal swabs will be collected from each participant recruited in the study.
Detailed description
The Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (referred to as "COVID-19 test") aims to develop a reverse transcription, real-time polymerase chain reaction (RT-qPCR) test for the qualitative detection of SARS-CoV-2.
The purpose of this study is to evaluate the clinical performance of the TaqPath™ COVID-19 Diagnostic PCR Kit (COVID-19 test) in nasopharyngeal swabs and anterior nasal swabs from symptomatic individuals suspected of COVID-19 by their health care provider.
A composite comparator approach will be used to evaluate the performance of the COVID-19 test which includes the use of three highly sensitive SARS-CoV-2 molecular assays as comparators. Clinical calls will be compared between COVID-19 test and the three composite comparators. The third comparator assay will only be used to test samples that show discrepant clinical calls between the first two comparator methods, for a two-out-of-three result interpretation. The Clinical Performance Study Protocol (CPS Protocol) outlines the clinical sample collection and testing protocols which will be used to satisfy the FDA 510(k) study requirements in the US.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 | – | Diagnostic Test: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitNasopharyngeal and anterior nasal swabs collected from symptomatic individuals suspected of COVID-19 by their health care provider. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be composed of participants suspected of COVID-19. After a subject is determined eligible for study participation (met inclusion criteria and did not meet exclusion criteria) and has completed the institutional review board (IRB)-approved informed consent form process (or assent, as age appropriate), the subject is enrolled into the study.
Key inclusion criteria (9 listed)
- Participants of all ages must meet the following inclusion criteria to be eligible for participation in the study:
- Ability to provide informed consent or assent (as age-appropriate). Stated willingness and ability to comply with the study procedures including nasopharyngeal and anterior nasal swab collection.
- Individuals with at least one of the following COVID-19 symptoms:
- Subjects suspected of having COVID-19 symptoms for seven (7) or fewer days.
Key exclusion criteria (3 listed)
- Subjects suspected of having COVID-19 symptoms for greater than seven (7) days.
- Subjects who have provided upper respiratory tract samples for other clinical studies within twenty-four (24) 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 |
|---|---|---|
| Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitA reverse transcription, real-time polymerase chain reaction (RT-qPCR) test for the qualitative detection of SARS-CoV-2. | Diagnostic test | SARS-CoV-2 |
Primary outcome
Clinical performance evaluation of the COVID-19 test
Time frame: Between April 2023 and August 2023
Clinical performance evaluation of the COVID-19 test using a composite comparator approach with upper respiratory specimens to meet PPA and NPA requirements.
Identification of adverse events
Time frame: Between April 2023 and August 2023
Identify any adverse events or complications associated with the COVID-19 test
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 18 Oct 2023.
- Individual participant dataSharing planned: No
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Coronavirus Infections, run by Thermo Fisher Scientific, Inc at 11 sites 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 9 inclusion and 3 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 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Clinical performance evaluation of the COVID-19 test (time frame: Between April 2023 and August 2023). The study lists 2 primary outcomes in all. 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 18 Oct 2023.