Clinical trial NCT04575168: Clinical Study Spartan COVID-19 V2 System
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Spartan Bioscience Inc.
Sponsor class: INDUSTRY
Collaborators: name: Beaufort
First posted: 2020-10-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
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 60 positives and \> 40 negatives (as determined by the SOC - Comparator method) in the United States and/or Canada. One to three sites in the United States and/or Canada will participate over an approximate 12-week enrolment period. The actual enrolment period will be dependent upon prevalence of Covid-19. Once positives sample size is achieved, expected SARC-CoV-2 negative subjects will be permitted.

This study is observational and will not impact the medical management of the patient. The results of the Spartan Test will be blinded to the clinical staff during the study and will not impact the medical management of the subject.

Once informed consent is obtained and eligibility is confirmed, subject demographics, and patient reported COVID-19 symptoms will be recorded. For the purposes of this study, enrolment will be defined as the collection of the two study-specific nasopharyngeal (NP) samples for Spartan's Test. Each patient's active involvement in the study will last for approximately 30 minutes.

To support the EUA, a minimum of 30 individual natural positive clinical specimens will be collected from patients suspected of SARS-CoV-2 infection by a healthcare provider in COVID-19 disease endemic regions in the United States. Additionally, a minimum of 30 individual negative samples will also be used to support the EUA from patients in the United States.

Once subjects are consented and recruited for the study, three nasopharyngeal samples for each patient will be collected by trained operators at the clinical site. The first 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. The third nasopharyngeal sample 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.

The sample for the SOC test will be collected prior to the samples for the Spartan COVID-19 v2 System as per clinical regulations.


Eligibility criteria: Inclusion Criteria:

* Individuals suspected of SARS-CoV-2 infection by a healthcare provider
* Individuals whose first symptom onset occurred less than or equal to 7 days of presentation
* Individual (or authorized representative) able or willing to provide written informed consent for study participation

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: 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sandy Springs
country: United States
facility: Wake Research Mt. Vernon
state: Georgia
city: Baltimore
country: United States
facility: Clinical Chemistry Research Lab, University of Maryand-Baltimore
state: Maryland
city: Chattanooga
country: United States
facility: Wake Research ClinSearch
state: Tennessee
Study officials:
References: