SARS-CoV-2 InfectionSTARFISHNCT05727202
Project STARFISH - PRJ0002679
An observational study of SARS-CoV-2 Infection and Influenza A, run by Thermo Fisher Scientific, Inc at 17 sites in United States.
Trial summary
This is a non-interventional study to perform the clinical performance evaluation of the Starfish Test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2 Infection, Influenza A, Influenza Type B
- What is being tested?
- The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
- How many people
- 1,909 participants
- Where
- 17 sitesUnited States
- Study dates
- 20 Feb 2023to 2 Apr 2024
- 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 respiratory tract infection from SARS-COV-2, Influenza A/B, or RSV. 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.
- All-comers phase: Individuals suspected to have respiratory tract infection for seven (7) or fewer days.
- Enrichment phase: Individuals suspected to have respiratory tract infection for seven (7) or fewer days, and with a standard of care positive PCR test result within three (3) days.
Who cannot join
- Participants meeting the following criterion will be excluded from the study:
- Suspected to have respiratory tract infection for greater than seven (7) days.
- Patients not suspected of having a respiratory tract infection.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
ClinSearch
Chattanooga, Tennessee, 37421
KUR Research at Columbia Medical Practice
Columbia, Maryland, 21045
Vida Clinical Studies
Dearborn Heights, Michigan, 48127
Quantigen
Fishers, Indiana, 46037
Mako Medical Laboratories
Henderson, North Carolina, 27537
KUR Research at AFC Urgent Care
Hillsdale, New Jersey, 07642
Helios Clinical Research
Jackson, Tennessee, 38305
MRI Global
Kansas City, Missouri, 64110
Helios Clinical Research
Keller, Texas, 76248
Multi-Specialty Research Associates
Lake City, Florida, 32055
Clinical Research Center of Nevada
Las Vegas, Nevada, 89106
D&H National Research Centers
Miami, Florida, 33155
KUR Research at AFC Urgent Care
Paramus, New Jersey, 07652
Granger Medical Clinic
Riverton, Utah, 84096
Women's Health Care Research
San Diego, California, 92111
Medical Center for Clinical Research
San Diego, California, 92120
Progressive Medicine of the Triad
Winston-Salem, North Carolina, 27103
About this study
Official title: IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679
This is a non-interventional study to perform the clinical performance evaluation of the Starfish Test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor.
Read the detailed description
The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (referred to below as "Starfish Test") aims to develop a multiplex real-time PCR IVD test for the qualitative detection and identification of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
The purpose of this performance study is to evaluate the clinical performance of the Starfish Test compared with that of a comparator device using upper respiratory specimens from subjects who have provided consent to participate in the study and meet the inclusion criteria. This 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
- SARS-CoV-2 Infection, Influenza A, Influenza Type B, RSV Infection
- Being tested
- The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
- Medical subject headings
- COVID-19, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select PanelDiagnostic test
A multiplex real-time PCR IVD test for the qualitative detection and identification of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 infection | 50 positive samples 500 negative samples Receives: Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel | |
| Influenza A infection | 50 positive samples 500 negative samples Receives: Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel | |
| Influenza B infection | 30 positive samples 500 negative samples Receives: Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel | |
| RSV infection | 30 positive samples 500 negative samples Receives: Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
The primary endpoint of this clinical performance study is to meet the minimum sample positivity requirements for nasopharyngeal samples as defined by relevant regulatory guidance.
Measured: Between February 2023 and April 2024
Secondary outcomes (1)
Secondary Endpoint
The secondary endpoint of this study is to complete the clinical performance evaluation of the Starfish Test compared with that of a predicate device using Anterior nasal specimens and meet the minimum PPA and NPA requirements and acceptance criteria for each viral target as summarized in the protocol.
Measured: Between February 2023 and April 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start20 Feb 2023
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies 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
- 1,909 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thermo Fisher Scientific, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727202
- Sponsor's protocol ID
- PCP0127284
- Acronym
- STARFISH
- Status last verified
- Apr 2024
- First submitted
- 26 Jan 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679
- ClinicalTrials.gov ID
- NCT05727202
- Acronym / sponsor ID
- STARFISH / PCP0127284
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza Type B, RSV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,909 participants (actual)
- Lead sponsor
- Thermo Fisher Scientific, IncIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 14 Feb 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 is a non-interventional study to perform the clinical performance evaluation of the Starfish Test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor.
Detailed description
The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (referred to below as "Starfish Test") aims to develop a multiplex real-time PCR IVD test for the qualitative detection and identification of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
The purpose of this performance study is to evaluate the clinical performance of the Starfish Test compared with that of a comparator device using upper respiratory specimens from subjects who have provided consent to participate in the study and meet the inclusion criteria. This 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
- 4
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 infection | – | Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel50 positive samples 500 negative samples |
| Influenza A infection | – | Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel50 positive samples 500 negative samples |
| Influenza B infection | – | Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel30 positive samples 500 negative samples |
| RSV infection | – | Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel30 positive samples 500 negative samples |
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 respiratory tract infection from SARS-COV-2, Influenza A/B, or RSV. 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 (4 listed)
- Participants of all ages must meet the following inclusion criteria to be eligible for participation in the study.
Key exclusion criteria (3 listed)
- Participants meeting the following criterion will be excluded from the study:
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 |
|---|---|---|
| The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select PanelA multiplex real-time PCR IVD test for the qualitative detection and identification of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). | Diagnostic test | Influenza A infection, Influenza B infection, RSV infection, SARS-CoV-2 infection |
Primary outcome
Primary Endpoint
Time frame: Between February 2023 and April 2024
The primary endpoint of this clinical performance study is to meet the minimum sample positivity requirements for nasopharyngeal samples as defined by relevant regulatory guidance.
1 secondary outcome
Secondary Endpoint
Time frame: Between February 2023 and April 2024
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 30 Apr 2024.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection and Influenza A, run by Thermo Fisher Scientific, Inc at 17 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 4 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Primary Endpoint (time frame: Between February 2023 and April 2024). 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 30 Apr 2024.