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Spartan COVID-19 System: Evaluation of Clinical Sample Collection

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Spartan COVID-19 System
Sponsored by
Spartan Bioscience Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Humber River Hospital
  • The Univeristy of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Method 1- Nasopharyngeal Swab in transfer liquid

Method 2- Dipping of specialized swab in VTM

Method 3: Direct input of VTM

Method 4: Collection of nasal sample.

Arm Description

A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis

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.

Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 14, 2020
Last Updated
November 11, 2020
Sponsor
Spartan Bioscience Inc.
Collaborators
Humber River Hospital, The Ottawa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04473248
Brief Title
Spartan COVID-19 System: Evaluation of Clinical Sample Collection
Official Title
Evaluation of Clinical Sample Collection Project: Spartan COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 28, 2020 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spartan Bioscience Inc.
Collaborators
Humber River Hospital, The Ottawa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.
Masking
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.
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Method 1- Nasopharyngeal Swab in transfer liquid
Arm Type
Experimental
Arm Description
A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis
Arm Title
Method 2- Dipping of specialized swab in VTM
Arm Type
Experimental
Arm Description
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.
Arm Title
Method 3: Direct input of VTM
Arm Type
Experimental
Arm Description
Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis.
Arm Title
Method 4: Collection of nasal sample.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Spartan COVID-19 System
Intervention Description
PCR analysis of patient samples using the Spartan COVID-19 System
Primary Outcome Measure Information:
Title
Asses the % agreement between predicate results and Spartan COVID-19 results.
Description
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.
Time Frame
Through study completion; anticipated to be less than 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: must have tested positive for COVID-19 via the existing nucleic acid testing method. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Linseman, MSc
Organizational Affiliation
Spartan Bioscience Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Humber River Hospital
City
North York
State/Province
Ontario
ZIP/Postal Code
M3M 0B2
Country
Canada
Facility Name
The Univeristy of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Spartan COVID-19 System: Evaluation of Clinical Sample Collection

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