The RAPID COVID-19 TRIAGE Algorithm | NCT04353154

Studies
The RAPID COVID-19 TRIAGE Algorithm

NCT04353154

Sponsor

Ottawa Heart Institute Research Corporation

Status

Terminated

Last Update Posted

May 13, 2026Actual

Enrollment

66Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Spartan Cube Point-of Care Covid-19 test

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Health Canada revoked the device due to inaccurate results. Study was unable to be completed and data collected to date determined to be invalid.

Expanded Access Info

Start Date

Jun 15, 2020Actual

Primary Completion Date

May 17, 2022Actual

Completion Date

May 17, 2022Actual

First Submitted Date

Apr 15, 2020

First Submission Date that Met QC Criteria

Apr 15, 2020

First Posted Date

Apr 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2026

Last Update Posted Date

May 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Currently, testing for COVID-19 is carried out with swabs and blood tests that are sent to hospital laboratories for analysis. With the current technology, the turnaround time for test results may take any where from 8 hours up to several days for confirmation of whether you have COVID-19. This delay in diagnosis may delay care, prevent other testing modalities, consume isolation beds and deplete the valuable personal protective equipment (PPE) needed while providing treatment for patients with COVID-19.

Using a new, Health Canada approved technology, we can conduct the virus genetic testing at the bedside with a nostril and throat swab, with results in under 45 minutes. This new "point-of-care (POC)" technology, if proven accurate, may help future patients receive faster and more definitive treatment. At the same time, it might help health care teams to preserve resources and optimize care for patients (example: triage use of intensive care or isolation unit beds, determine need for PPE, get quarantined staff back to front line to help with care if they are non-carriers).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spartan Cube Point-of Care Covid-19 test	Diagnostic Test	Throat and nasal swab for COVID-19 point-of-care test.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Ottawa Heart Institute		Ottawa	Ontario	K1N 4W7	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

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Browse Branches

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