Spartan COVID-19 System: Evaluation of Clinical Sample Collection

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Humber River Hospital, North York, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Spartan COVID-19 System

Device

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Spartan Bioscience Inc.

Industry

Collaborators

Humber River Hospital
The Ottawa Hospital

Registry information

Official study title

Evaluation of Clinical Sample Collection Project: Spartan COVID-19

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jul 16, 2020
Registry last updated: Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed