N/A
N=464
Repeat Testing for SARS-CoV-2
COVID-19 · Sars-CoV-2
Bottom Line
View on ClinicalTrials.gov: NCT04579549 ↗Enrolled (actual)
464
Serious AEs
—
Results posted
Jan 2022
Primary outcome: Primary: Number of Participant Phone Surveys Conducted — 3 phone surveys
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Saliva Assay (Device)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant Phone Surveys Conducted |
3 | — |
| PRIMARY Number of Minimally Trained Personnel Who Achieve Assay Proficiency |
11 | — |
Summary
The purpose of this research study is to determine if high-frequency, rapid turn-around SARS-CoV-2 surveillance testing with this assay is feasible and able to be optimized to enable isolation and follow-up diagnostic testing. This test will be performed at various locations in the Madison, Wisconsin area using a mobile laboratory or standard lab space for processing. Saliva samples can be collected and processed at these locations or participants can self-collect at home and drop their samples off at designated locations for same day processing. Up to 10000 participants will be recruited for this study.
Eligibility Criteria
Inclusion Criteria
- Willing to provide informed consent.
- Willing to provide informed consent and spit into a vessel (i.e cup or tube).
- Individuals at least 18 years old or between 5-17 years old and have a parent or legal guardian present to consent.
- Adult subjects must have decision-making capacity to provide consent on their own behalf.
- Participants must be able to speak English
Exclusion Criteria
- Participants must not have visual or hearing impairments, or low literacy, that would prevent them from reading the consent form and interacting with a member of the research team to ask questions and receive responses during the consent process.
- Under 18 years of age with no parent or legal guardian present or under the age of 5 yrs
- Cannot speak English
Data sourced from ClinicalTrials.gov (NCT04579549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.