Project STARFISH - PRJ0002679

SARS-CoV-2 Infection Clinical Trial

— STARFISH  

Official title:

IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05727202
• Other study ID #: PCP0127284
• Status: Completed
• Start date: February 20, 2023
• Est. completion date: April 2, 2024

Study information

• Verified date: April 2024
• Source: Thermo Fisher Scientific, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1909
• Est. completion date: April 2, 2024
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Influenza A
• Influenza Type B
• Influenza, Human
• Respiratory Syncytial Virus Infections
• RSV Infection
• SARS-CoV-2 Infection

Intervention

Diagnostic Test:
• The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
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).

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Thermo Fisher Scientific, Inc	NAMSA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Between February 2023 and April 2024