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NCT04473248 Clinical Trial

Spartan COVID-19 System: Evaluation of Clinical Sample Collection

Covid19 Clinical Trial

Official title:
Evaluation of Clinical Sample Collection Project: Spartan COVID-19

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04473248
Other study ID # VNV-00552
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 28, 2020
Est. completion date August 30, 2020

Study information
Verified date July 2020
Source Spartan Bioscience Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date August 30, 2020
Est. primary completion date August 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - must have tested positive for COVID-19 via the existing nucleic acid testing method. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Humber River Hospital North York Ontario
Canada The Univeristy of Ottawa Heart Institute Ottawa Ontario

Sponsors (3)
Lead Sponsor Collaborator
Spartan Bioscience Inc. Humber River Hospital, The Ottawa Hospital

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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