Clinical Study Spartan COVID-19 V2 System
Assess the Performance of Spartan COVID-19 V2 System in a Clinical Setting in Comparison to a Laboratory (Standard of Care (SOC)) PCR Method
1 other identifier
observational
81
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2020
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedStudy Start
First participant enrolled
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2020
CompletedAugust 30, 2021
October 1, 2020
1 month
October 1, 2020
August 27, 2021
Conditions
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)
24hours
Study Arms (2)
Positive for COVID-19
Subjects positive for COVID-19 as indicated by the Standard of Care test.
Negative for COVID-19
Subjects negative for COVID-19 as indicated by the Standard of Care test.
Interventions
A nasopharyngeal sample analyzed on the Spartan COVID-19 System.
Eligibility Criteria
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:
- 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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spartan Bioscience Inc.lead
- Beaufortcollaborator
Study Sites (3)
Wake Research Mt. Vernon
Sandy Springs, Georgia, 30328, United States
Clinical Chemistry Research Lab, University of Maryand-Baltimore
Baltimore, Maryland, 21201, United States
Wake Research ClinSearch
Chattanooga, Tennessee, 37421, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2020
First Posted
October 5, 2020
Study Start
October 30, 2020
Primary Completion
December 7, 2020
Study Completion
December 7, 2020
Last Updated
August 30, 2021
Record last verified: 2020-10