Clinical trial NCT04628208: Clinical Study Spartan COVID-19 V2 System (Canada Alternate)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Spartan Bioscience Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-13
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Agreement between SOC test and Spartan COVID-19 test
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa hospital
state: Ontario
Study officials:
References: