Project STARFISH - PRJ0002679
STARFISH
IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679
1 other identifier
observational
1,909
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2023
CompletedFirst Posted
Study publicly available on registry
February 14, 2023
CompletedStudy Start
First participant enrolled
February 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2024
CompletedApril 30, 2024
April 1, 2024
1.1 years
January 26, 2023
April 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Between February 2023 and April 2024
Secondary Outcomes (1)
Secondary Endpoint
Between February 2023 and April 2024
Study Arms (4)
SARS-CoV-2 infection
50 positive samples 500 negative samples
Influenza A infection
50 positive samples 500 negative samples
Influenza B infection
30 positive samples 500 negative samples
RSV infection
30 positive samples 500 negative samples
Interventions
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).
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thermo Fisher Scientific, Inclead
- NAMSAcollaborator
Study Sites (17)
Women's Health Care Research
San Diego, California, 92111, United States
Medical Center for Clinical Research
San Diego, California, 92120, United States
Multi-Specialty Research Associates
Lake City, Florida, 32055, United States
D&H National Research Centers
Miami, Florida, 33155, United States
Quantigen
Fishers, Indiana, 46037, United States
KUR Research at Columbia Medical Practice
Columbia, Maryland, 21045, United States
Vida Clinical Studies
Dearborn Heights, Michigan, 48127, United States
MRI Global
Kansas City, Missouri, 64110, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89106, United States
KUR Research at AFC Urgent Care
Hillsdale, New Jersey, 07642, United States
KUR Research at AFC Urgent Care
Paramus, New Jersey, 07652, United States
Mako Medical Laboratories
Henderson, North Carolina, 27537, United States
Progressive Medicine of the Triad
Winston-Salem, North Carolina, 27103, United States
ClinSearch
Chattanooga, Tennessee, 37421, United States
Helios Clinical Research
Jackson, Tennessee, 38305, United States
Helios Clinical Research
Keller, Texas, 76248, United States
Granger Medical Clinic
Riverton, Utah, 84096, United States
Biospecimen
The study population will be composed of participants suspected of a respiratory tract infection from SARS-COV-2, Influenza A/B, or RSV. For this study, 1 nasopharyngeal swab and 1 nasal swab will be collected from each participant recruited prospectively from at least three (3) collection sites located in different geographical regions in the US.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2023
First Posted
February 14, 2023
Study Start
February 20, 2023
Primary Completion
April 2, 2024
Study Completion
April 2, 2024
Last Updated
April 30, 2024
Record last verified: 2024-04