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Clinical Study Spartan COVID-19 V2 System

NCT04575168 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2021-08-30

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Spartan COVID-19 Test

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

Sponsors & Collaborators

  • Beaufort

    collaborator UNKNOWN

  • Spartan Bioscience Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2020-12-07
Completion
2020-12-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575168 on ClinicalTrials.gov