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Performance Study of SONA Saliva C-19 Rapid Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04877002
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Sona Nanotech Inc

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

Condition or disease Intervention/treatment Phase
Covid19 Sars-CoV-2 Infection Corona Virus Infection Diagnostic Test: Sona Saliva C-19 Rapid Test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Novel Salivary Rapid Testing of SARS_CoV_2
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: SARS_CoV_2 Antigen Rapid Test

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
Rapid Antigen diagnostic device performance comparative to RT-PCR




Primary Outcome Measures :
  1. Percent Positive Agreement and Negative Percent Agreement [ Time Frame: 35 days from last patient enrolment ]
    Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877002


Contacts
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Contact: Research Manager 416-242-1000 ext 81263 mpetrovic@hrh.ca

Locations
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Canada, Ontario
Humber River Hospital Recruiting
Toronto, Ontario, Canada, M3M 0B2
Contact: Research Manager    416-242-1000 ext 81263    Mpetrovic@hrh.ca   
Principal Investigator: David Jacobs, Dr         
Sponsors and Collaborators
Sona Nanotech Inc
Investigators
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Principal Investigator: David Jacobs, Dr Humber River Hospital
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Responsible Party: Sona Nanotech Inc
ClinicalTrials.gov Identifier: NCT04877002    
Other Study ID Numbers: CT002-SalC19RT
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sona Nanotech Inc:
Antigen
COVID19
Rapid Test
Saliva
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases