Performance Study of SONA Saliva C-19 Rapid Test

Covid19 Clinical Trial

Official title:

Novel Salivary Rapid Testing of SARS_CoV_2

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04877002
• Other study ID #: CT002-SalC19RT
• Status: Terminated
• Phase: N/A
• Start date: April 29, 2021
• Est. completion date: January 5, 2022

Study information

• Verified date: March 2023
• Source: Sona Nanotech Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 5, 2022
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Presenting to the Emergency Department at HRH.

2. Receiving a COVID-19 RT-PCR test as per standard pathway of care.

3. Provide written informed consent.

4. 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:

1. Asymptomatic patients.

2. Patients unable to provide a saliva sample.

3. Patients unable to give consent.

4. Patients who will not be receiving a nasopharyngeal RT-PCR test.

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Infections
• Sars-CoV-2 Infection

Intervention

Diagnostic Test:
• Sona Saliva C-19 Rapid Test
Rapid Antigen diagnostic device performance comparative to RT-PCR

Locations

Country	Name	City	State
Canada	Humber River Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sona Nanotech Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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