Spartan COVID-19 System: Evaluation of Clinical Sample Collection

NCT04473248 | Completed

• 1 other identifier: VNV-00552
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion; anticipated to be less than 6 months.

Study Arms (4)

Method 1- Nasopharyngeal Swab in transfer liquid

EXPERIMENTAL

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

Method 2- Dipping of specialized swab in VTM

EXPERIMENTAL

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

Method 3: Direct input of VTM

EXPERIMENTAL

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

Method 4: Collection of nasal sample.

EXPERIMENTAL

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

Interventions

Spartan COVID-19 System DEVICE

PCR analysis of patient samples using the Spartan COVID-19 System

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Spartan Bioscience Inc.: lead
• Humber River Hospital: collaborator
• The Ottawa Hospital: collaborator

Study Sites (2)

Humber River Hospital

North York, Ontario, M3M 0B2, Canada

Location

The Univeristy of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tara Linseman, MSc

  Spartan Bioscience Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 16, 2020
• Study Start: June 28, 2020
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-07

Locations

CA (2)