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Spartan COVID-19 System: Evaluation of Clinical Sample Collection

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: NCT04473248
Recruitment Status : Completed
First Posted : July 16, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborators:
Humber River Hospital
The Ottawa Hospital
Information provided by (Responsible Party):
Spartan Bioscience Inc.

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
Covid19 Device: Spartan COVID-19 System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : June 28, 2020
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : August 30, 2020

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


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): NCT04473248


Locations
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Canada, Ontario
Humber River Hospital
North York, Ontario, Canada, M3M 0B2
The Univeristy of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7
Sponsors and Collaborators
Spartan Bioscience Inc.
Humber River Hospital
The Ottawa Hospital
Investigators
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Study Director: Tara Linseman, MSc Spartan Bioscience Inc.
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Responsible Party: Spartan Bioscience Inc.
ClinicalTrials.gov Identifier: NCT04473248    
Other Study ID Numbers: VNV-00552
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No