Spartan COVID-19 System: Evaluation of Clinical Sample Collection

November 11, 2020 updated by: Spartan Bioscience Inc.

Evaluation of Clinical Sample Collection Project: Spartan COVID-19

This study will evaluate the efficacy of various sample collection methods for use with the Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with results that are obtained using a predicate lab-based COVID-19 test that uses a nasopharyngeal swab sample. The goal is to determine which sample collection methods are most effective in capturing SARS-CoV-2 virus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Once the subject is recruited,two nasopharyngeal swabs using the standard method will be taken from the patient. Additionally, two nasal swab samples will be taken using the Spartan COVID-19 swabs with an adjusted tip. All samples will be analyzed using the Spartan COVID-19 System.

The lab-based predicate test will be taken at the same time, with results reported back to Spartan to be compared with results obtained from the Spartan COVID-19 System.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • North York, Ontario, Canada, M3M 0B2
        • Humber River Hospital
      • Ottawa, Ontario, Canada, K1Y4W7
        • The Univeristy of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • must have tested positive for COVID-19 via the existing nucleic acid testing method.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Method 1- Nasopharyngeal Swab in transfer liquid
A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis
Device: Spartan COVID-19 System
PCR analysis of patient samples using the Spartan COVID-19 System
Experimental: Method 2- Dipping of specialized swab in VTM
A nasopharyngeal swab will inoculate VTM solution. A modified traditional Spartan Swab will be dipped into the inoculated VTM solution and then transferred to the Spartan COVID-19 System for analysis.
Device: Spartan COVID-19 System
PCR analysis of patient samples using the Spartan COVID-19 System
Experimental: Method 3: Direct input of VTM
Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis.
Device: Spartan COVID-19 System
PCR analysis of patient samples using the Spartan COVID-19 System
Experimental: Method 4: Collection of nasal sample.
Using a modified tip of the Spartan swab, a nasal sample will be taken from the patient and directly placed into the Spartan COVID-19 System for analysis.
Device: Spartan COVID-19 System
PCR analysis of patient samples using the Spartan COVID-19 System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asses the % agreement between predicate results and Spartan COVID-19 results.
Time Frame: Through study completion; anticipated to be less than 6 months.
The purpose of this study is to evaluate which method has the best % agreement between the lab-based predicate results and Spartan COVID-19 System results.
Through study completion; anticipated to be less than 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spartan Bioscience Inc.

Collaborators

The Ottawa Hospital
Humber River Hospital

Investigators

  • Study Director: Tara Linseman, MSc, Spartan Bioscience Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2020

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

August 30, 2020

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VNV-00552

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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