Clinical trial NCT04877002: Performance Study of SONA Saliva C-19 Rapid Test
Official title: Novel Salivary Rapid Testing of SARS_CoV_2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Covid19
Sars-CoV-2 Infection
Corona Virus Infection
Keywords: Antigen
COVID19
Rapid Test
Saliva
Lead sponsor: Sona Nanotech Inc
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

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:

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.

Primary outcomes:
measure: Percent Positive Agreement and Negative Percent Agreement
timeFrame: 35 days from last patient enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
Study officials:
affiliation: Humber River Hospital
name: David Jacobs, Dr
role: PRINCIPAL_INVESTIGATOR
References: