Clinical Study Spartan COVID-19 V2 System

Sponsor

Spartan Bioscience Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04575168

Collaborator

Beaufort (Other)

Enrollment

Locations

1.2

Actual Duration (Months)

Patients Per Site

21.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multicentre prospective study will enroll a sufficient number of patients to afford approximately 60 positives and > 40 negatives (as determined by the SOC - Comparator method) in the United States and/or Canada. One to three sites in the United States and/or Canada will participate over an approximate 12-week enrolment period. The actual enrolment period will be dependent upon prevalence of Covid-19. Once positives sample size is achieved, expected SARC-CoV-2 negative subjects will be permitted.

This study is observational and will not impact the medical management of the patient. The results of the Spartan Test will be blinded to the clinical staff during the study and will not impact the medical management of the subject.

Once informed consent is obtained and eligibility is confirmed, subject demographics, and patient reported COVID-19 symptoms will be recorded. For the purposes of this study, enrolment will be defined as the collection of the two study-specific nasopharyngeal (NP) samples for Spartan's Test. Each patient's active involvement in the study will last for approximately 30 minutes.

To support the EUA, a minimum of 30 individual natural positive clinical specimens will be collected from patients suspected of SARS-CoV-2 infection by a healthcare provider in COVID-19 disease endemic regions in the United States. Additionally, a minimum of 30 individual negative samples will also be used to support the EUA from patients in the United States.

Once subjects are consented and recruited for the study, three nasopharyngeal samples for each patient will be collected by trained operators at the clinical site. The first sample will be tested at the clinical site according to standard of care protocols currently in place for the sites' nasopharyngeal swab-based SARS-CoV-2 RT-PCR testing. The second nasopharyngeal sample will be tested at the site using the Spartan COVID-19 v2 System. The third nasopharyngeal sample will be tested using the Spartan COVID-19 v2 System only when the test conducted with the second nasopharyngeal swab does not produce a positive or negative result.

The sample for the SOC test will be collected prior to the samples for the Spartan COVID-19 v2 System as per clinical regulations.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Diagnostic Test: Spartan COVID-19 Test

Study Design

Study Type:

Observational

Actual Enrollment :

81 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Assess the Performance of Spartan COVID-19 V2 System in a Clinical Setting in Comparison to a Laboratory (Standard of Care (SOC)) PCR Method

Actual Study Start Date :

Oct 30, 2020

Actual Primary Completion Date :

Dec 7, 2020

Actual Study Completion Date :

Dec 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Positive for COVID-19 Subjects positive for COVID-19 as indicated by the Standard of Care test.	Diagnostic Test: Spartan COVID-19 Test A nasopharyngeal sample analyzed on the Spartan COVID-19 System.
Negative for COVID-19 Subjects negative for COVID-19 as indicated by the Standard of Care test.	Diagnostic Test: Spartan COVID-19 Test A nasopharyngeal sample analyzed on the Spartan COVID-19 System.

Arm

Intervention/Treatment

Positive for COVID-19

Subjects positive for COVID-19 as indicated by the Standard of Care test.

Diagnostic Test: Spartan COVID-19 Test

A nasopharyngeal sample analyzed on the Spartan COVID-19 System.

Negative for COVID-19

Subjects negative for COVID-19 as indicated by the Standard of Care test.

Diagnostic Test: Spartan COVID-19 Test

A nasopharyngeal sample analyzed on the Spartan COVID-19 System.

Outcome Measures

Primary Outcome Measures

Percent Agreement between SOC test and Spartan COVID-19 test [24hours]
Overall percent agreement between the test results generated by the Spartan COVID-19 v2 System and the nasopharyngeal swab-based SARS-Cov-2 test currently in use at the clinical site (SOC test)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Individuals suspected of SARS-CoV-2 infection by a healthcare provider
Individuals whose first symptom onset occurred less than or equal to 7 days of presentation
Individual (or authorized representative) able or willing to provide written informed consent for study participation

Exclusion Criteria:

Vulnerable populations (e.g., women with pregnancy, institutionalized individual) as deemed inappropriate for study by the site investigator
Individuals with self-reported nosebleed within 24 hours of presentation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Research Mt. Vernon	Sandy Springs	Georgia	United States	30328
2	Clinical Chemistry Research Lab, University of Maryand-Baltimore	Baltimore	Maryland	United States	21201
3	Wake Research ClinSearch	Chattanooga	Tennessee	United States	37421

Sponsors and Collaborators

Spartan Bioscience Inc.
Beaufort

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Spartan Bioscience Inc.

ClinicalTrials.gov Identifier:

NCT04575168

Other Study ID Numbers:

VNV-00615

First Posted:

Oct 5, 2020

Last Update Posted:

Aug 30, 2021

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Aug 30, 2021