Clinical Study Spartan COVID-19 V2 System

NCT ID: NCT04575168

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2020-12-07

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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Positive for COVID-19

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

Spartan COVID-19 Test

Intervention Type: DIAGNOSTIC_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.

Spartan COVID-19 Test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Spartan COVID-19 Test

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beaufort

UNKNOWN

Sponsor Role: collaborator

Spartan Bioscience Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wake Research Mt. Vernon

Sandy Springs, Georgia, United States

Clinical Chemistry Research Lab, University of Maryand-Baltimore

Baltimore, Maryland, United States

Wake Research ClinSearch

Chattanooga, Tennessee, United States

Countries

United States

Other Identifiers

VNV-00615

Identifier Type: -

Identifier Source: org_study_id