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

Spartan Bioscience

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: Spartan COVID-19 v2 System

Study type: Observational

Funder types: Industry

Identifiers

NCT04628208

VNV-00635

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

81 participants in 2 patient groups

Negative for COVID-19

Description:

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

Treatment:

Diagnostic Test: Spartan COVID-19 v2 System

Positive for COVID-19

Description:

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

Treatment:

Diagnostic Test: Spartan COVID-19 v2 System