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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.

Tracking Information
First Submitted Date  ICMJE July 14, 2020
First Posted Date  ICMJE July 16, 2020
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE June 28, 2020
Actual Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spartan COVID-19 System: Evaluation of Clinical Sample Collection
Official Title  ICMJE Evaluation of Clinical Sample Collection Project: Spartan COVID-19
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Covid19
Intervention  ICMJE Device: Spartan COVID-19 System
PCR analysis of patient samples using the Spartan COVID-19 System
Study Arms  ICMJE
  • 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
    Intervention: Device: 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.
    Intervention: Device: 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.
    Intervention: Device: 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.
    Intervention: Device: Spartan COVID-19 System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2020)
27
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2020)
30
Actual Study Completion Date  ICMJE August 30, 2020
Actual Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04473248
Other Study ID Numbers  ICMJE VNV-00552
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spartan Bioscience Inc.
Study Sponsor  ICMJE Spartan Bioscience Inc.
Collaborators  ICMJE
  • Humber River Hospital
  • The Ottawa Hospital
Investigators  ICMJE
Study Director: Tara Linseman, MSc Spartan Bioscience Inc.
PRS Account Spartan Bioscience Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP