Clinical Study Spartan COVID-19 V2 System (Canada Alternate)

NCT04628208 | Completed

• 1 other identifier: VNV-00635
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This multicentre prospective study will enroll a sufficient number of patients to afford approximately 30 positives and \> 30 negatives (as determined by the SOC - Comparator method) in the United States and/or Canada. One to three sites in the Canada will participate over an approximate 6-week enrolment period. The actual enrolment period will be dependent upon prevalence of Covid-19, and site set up. Once positives sample size is achieved, expected SARC-CoV-2 negative subjects will be permitted. Once subjects are consented and recruited for the study, up to three (3) study-specific nasopharyngeal samples for each patient will be collected by trained operators at the clinical site: a single SOC swab, and two (2) Spartan swabs where the second swab is optional and used when the first Spartan swab test does not produce a positive or negative result ("inconclusive"). The first swab sample will be tested at the clinical site according to standard of care protocols currently in place for the sites' nasopharyngeal swab-based SARS-CoV-2 RT-PCR testing. The second nasopharyngeal sample will be tested at the site using the Spartan COVID-19 v2 System. A third, optional nasopharyngeal sample, if collected, will be tested using the Spartan COVID-19 v2 System only when the test conducted with the second nasopharyngeal swab does not produce a positive or negative result.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Percent Agreement between SOC test and Spartan COVID-19 test

  Overall percent agreement between the test results generated by the Spartan COVID-19 v2 System and the nasopharyngeal swab-based SARS-Cov-2 test currently in use at the clinical site (SOC test)

  24 hours

Study Arms (2)

Negative for COVID-19

Subject determined to be negative for COVID-19 by the standard of care nasopharyngeal swab-based SARS-CoV-2 RT-PCR test.

Diagnostic Test: Spartan COVID-19 v2 System

Positive for COVID-19

Subject determined to be positive for COVID-19 by the standard of care nasopharyngeal swab-based SARS-CoV-2 RT-PCR test.

Diagnostic Test: Spartan COVID-19 v2 System

Interventions

Spartan COVID-19 v2 System DIAGNOSTIC_TEST

A nasopharyngeal swab sample analyzed on the Spartan COVID-19 v2 System for the detection of SARS-CoV-2.

Negative for COVID-19; Positive for COVID-19

Eligibility Criteria

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

Study Population

Subjects presenting to clinical study sites with symptoms of SARS-CoV-2 or suspected of SARS-Cov-2 infection by a healthcare provider

You may qualify if:

• Suspected SARS-CoV-2 infection by a healthcare provider, and whose first symptoms presented ≤ 7 days of onset; or
• Suspected SARS-CoV-2 infection from the same household of a person who tested positive for SARS-CoV-2 using an authorized test; or
• Known positive SARS-CoV-2 infection using an authorized test, and whose first symptoms presented ≤ 7 days of onset; or
• Expected negative SARS-CoV-2 infection - individuals with no symptoms or a recent negative result by an authorized test.

You may not qualify if:

• Vulnerable populations (e.g., women with pregnancy, institutionalized individual) as deemed inappropriate for study by the site investigator
• Individuals with self-reported nosebleed within 24 hours of presentation

Sponsors & Collaborators

• Spartan Bioscience Inc.: lead

Study Sites (1)

The Ottawa hospital

Ottawa, Ontario, K1Y4E9, 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 Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 13, 2020
• Study Start: November 17, 2020
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

CA (1)