Project STARFISH - PRJ0002679

Completed

Conditions studied: SARS-CoV-2 Infection, Influenza A, Influenza Type B, RSV Infection

In brief

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.

Key facts

Study ID

NCT05727202

Run by

Thermo Fisher Scientific, Inc

People needed

1909

Starts

2023-02-20

Expected to finish

2024-04-02

Last updated by the study team

2024-04-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.

Where it is running

• Women's Health Care Research — San Diego, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Multi-Specialty Research Associates — Lake City, Florida, United States
• D&H National Research Centers — Miami, Florida, United States
• Quantigen — Fishers, Indiana, United States
• KUR Research at Columbia Medical Practice — Columbia, Maryland, United States
• Vida Clinical Studies — Dearborn Heights, Michigan, United States
• MRI Global — Kansas City, Missouri, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• KUR Research at AFC Urgent Care — Hillsdale, New Jersey, United States
• KUR Research at AFC Urgent Care — Paramus, New Jersey, United States
• Mako Medical Laboratories — Henderson, North Carolina, United States
• Progressive Medicine of the Triad — Winston-Salem, North Carolina, United States
• ClinSearch — Chattanooga, Tennessee, United States
• Helios Clinical Research — Jackson, Tennessee, United States
• Helios Clinical Research — Keller, Texas, United States
• Granger Medical Clinic — Riverton, Utah, United States

Full record on ClinicalTrials.gov

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