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Spartan COVID-19 System: Evaluation of Clinical Sample Collection

Sponsor
Spartan Bioscience Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04473248
Collaborator
Humber River Hospital (Other), The Ottawa Hospital (Other)
27
Enrollment
2
Locations
4
Arms
2.1
Actual Duration (Months)
13.5
Patients Per Site
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Spartan COVID-19 System
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.
Masking:
Single (Participant)
Masking Description:
The results of the Spartan COVID-19 System tests will not be shared with the participant or the lab, but the lab results will be shared with Spartan once analysis of the Spartan System samples is complete.
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Clinical Sample Collection Project: Spartan COVID-19
Actual Study Start Date :
Jun 28, 2020
Actual Primary Completion Date :
Aug 30, 2020
Actual Study Completion Date :
Aug 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Asses the % agreement between predicate results and Spartan COVID-19 results. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • must have tested positive for COVID-19 via the existing nucleic acid testing method.
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Humber River Hospital North York Ontario Canada M3M 0B2
2 The Univeristy of Ottawa Heart Institute Ottawa Ontario Canada K1Y4W7

Sponsors and Collaborators

  • Spartan Bioscience Inc.
  • Humber River Hospital
  • The Ottawa Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Spartan Bioscience Inc.
ClinicalTrials.gov Identifier:
NCT04473248
Other Study ID Numbers:
  • VNV-00552
First Posted:
Jul 16, 2020
Last Update Posted:
Nov 13, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Nov 13, 2020