Status:
TERMINATED
Performance Study of SONA Saliva C-19 Rapid Test
Lead Sponsor:
Sona Nanotech Inc
Conditions:
Covid19
Sars-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 o...
Eligibility Criteria
Inclusion
- 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:
- Fever as self-described or measured ≥ 38 °C (100.4°F)
- Chills
- Cough
- Shortness of breath
- Congestion or runny nose
- Difficulty Breathing
- Muscle or Body Aches
- Vomiting
- Diarrhea
- New loss of sense of taste or smell
- Headache
- General malaise
- Sore Throat
Exclusion
- 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.
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04877002
Start Date
April 29 2021
End Date
January 5 2022
Last Update
March 24 2023
Active Locations (1)
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1
Humber River Hospital
Toronto, Ontario, Canada, M3M 0B2