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

Covid19 Clinical Trial

Official title:

Assess the Performance of Spartan COVID-19 V2 System in a Clinical Setting in Comparison to a Laboratory (Standard of Care (SOC)) PCR Method (Canada Alternate)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628208
• Other study ID #: VNV-00635
• Status: Completed
• Start date: November 17, 2020
• Est. completion date: December 7, 2020

Study information

• Verified date: August 2021
• Source: Spartan Bioscience Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Spartan Bioscience Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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