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Clinical Study Spartan COVID-19 V2 System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04575168
Recruitment Status : Completed
First Posted : October 5, 2020
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
Beaufort
Information provided by (Responsible Party):
Spartan Bioscience Inc.

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
Covid19 Diagnostic Test: Spartan COVID-19 Test

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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 : October 30, 2020
Actual Primary Completion Date : December 7, 2020
Actual Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. Percent Agreement between SOC test and Spartan COVID-19 test [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects presenting to clinical study sites with symptoms of SARS-CoV-2 or suspected of SARS-Cov-2 infection by a healthcare provider
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04575168


Locations
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United States, Georgia
Wake Research Mt. Vernon
Sandy Springs, Georgia, United States, 30328
United States, Maryland
Clinical Chemistry Research Lab, University of Maryand-Baltimore
Baltimore, Maryland, United States, 21201
United States, Tennessee
Wake Research ClinSearch
Chattanooga, Tennessee, United States, 37421
Sponsors and Collaborators
Spartan Bioscience Inc.
Beaufort
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Responsible Party: Spartan Bioscience Inc.
ClinicalTrials.gov Identifier: NCT04575168    
Other Study ID Numbers: VNV-00615
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases