NCT04353154

Brief Summary

This study is being conducted to study the use and application of a point-of-care (POC) Covid-19 test developed by Spartan BioSciences and recently approved for clinical use by Health Canada. Phase I of this study will determine the best route for the swabs (nasal, throat, or both), and to determine if this POC test results are comparable to the standard core-lab test results.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress98%
Jun 2020Jun 2026

First Submitted

Initial submission to the registry

April 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2026

Expected
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

4.8 years

First QC Date

April 15, 2020

Last Update Submit

December 5, 2024

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    For the analysis, this will be based on a comparison of the identified patients in the core lab with the POC testing with the following data to arrive at an early sensitivity: Sensitivity = True Positive/ (True positive/True positive + False Negative)

    1 month

Interventions

Spartan Cube Point-of Care Covid-19 testDIAGNOSTIC_TEST

Throat and nasal swab for COVID-19 point-of-care test.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population is admitted patients who have had a positive core-lab virology test for COVID-19.

You may qualify if:

  • Patients ≥ 18 yo referred to the cardiology, internal medicine, ICU, CICU, CSICU or RACE teams who have tested positive for COVID-19.

You may not qualify if:

  • Patients in whom conventional COVID-19 testing would not have otherwise been instituted or in whom immediate test results would not alter short-term treatment, Patients with pre-existing wishes for DNR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1N 4W7, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 20, 2020

Study Start

June 15, 2020

Primary Completion

March 31, 2025

Study Completion (Estimated)

June 28, 2026

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)