Performance Study of SONA Saliva C-19 Rapid Test | NCT04877002

Studies
Performance Study of SONA Saliva C-19 Rapid Test

NCT04877002

Sponsor

Sona Nanotech Inc

Status

Terminated

Last Update Posted

Mar 24, 2023Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Covid19
Sars-CoV-2 Infection
Corona Virus Infection

Interventions

Sona Saliva C-19 Rapid 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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Limited participants

Expanded Access Info

Start Date

Apr 29, 2021Actual

Primary Completion Date

Jun 10, 2021Actual

Completion Date

Jan 5, 2022Actual

First Submitted Date

May 3, 2021

First Submission Date that Met QC Criteria

May 3, 2021

First Posted Date

May 7, 2021Actual

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

Mar 22, 2023

Last Update Posted Date

Mar 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The Sona Saliva C-19 Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to a RT-PCR reference method

Detailed Description

The clinical performance of the Sona Saliva C-19 Rapid Test will be evaluated in a prospective clinical study conducted at a single (1) investigational site in Toronto, Cananda.

Consenting patients of ages 18+, any gender, or race/ethnicity who presents at the test site with COVID-19 like symptoms during the 2021 COVID-19 season will be asked to take part in the study, will be sequentially enrolled and tested.

Trained operators with laboratory experience who have received training on the use of the Sona Saliva C-19 Rapid Test will conduct the testing and represent the intended users.

A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process, study questionnaire and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number, be asked to provide a sample for testing.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SARS_CoV_2 Antigen Rapid Test	Experimental	The same group of patients participated in two arms of the study: One arm was for obtaining performance data of the Sona Saliva C-19 Rapid test and the comparator arm was to obtain data from the primary care route using approved RT-PCR testing.	Diagnostic Test: Sona Saliva C-19 Rapid Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sona Saliva C-19 Rapid Test	Diagnostic Test	Rapid Antigen diagnostic device performance comparative to RT-PCR	SARS_CoV_2 Antigen Rapid Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Positive Agreement and Negative Percent Agreement	Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens.	35 days from last patient enrolment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Up to 500 subjects will be screened, consented, and enrolled to obtain a minimum of 50 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Presenting to the Emergency Department at HRH.
Receiving a COVID-19 RT-PCR test as per standard pathway of care.
Provide written informed consent.
Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 days:
1. Fever as self-described or measured ≥ 38 °C (100.4°F)
2. Chills
3. Cough
4. Shortness of breath
5. Congestion or runny nose
6. Difficulty Breathing
7. Muscle or Body Aches
8. Vomiting
9. Diarrhea
10. New loss of sense of taste or smell
11. Headache
12. General malaise
13. Sore Throat

Exclusion Criteria:

Asymptomatic patients.
Patients unable to provide a saliva sample.
Patients unable to give consent.
Patients who will not be receiving a nasopharyngeal RT-PCR test.

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

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
David Jacobs, Dr	Humber River Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Humber River Hospital		Toronto	Ontario	M3M 0B2	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
D018352	Coronavirus Infections

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

The purpose of this study is to validate the performance of the Sona Saliva C-19 rapid Test for rapid detection of SARS_CoV_2 infection when using saliva specimens. A prospective randomized and blinded study to evaluate a rapid point of care antigen test for the detection of viral proteins and compared against an approved RT-PCR test.

Saliva samples will be collected along with the current standard of care collection.