N/A
N=93
Rapid, Onsite COVID-19 Detection
COVID-19 · Sars-CoV2
Bottom Line
View on ClinicalTrials.gov: NCT04460690 ↗Enrolled (actual)
93
Serious AEs
—
Results posted
Jan 2022
Primary outcome: Primary: Number of Samples Tested — 3692 samples
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rapid Onsite COVID-19 Detection (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 Samples Tested |
3692 | — |
| PRIMARY Safety: Number of Participants Who Tested Positive for COVID-19 |
16; 0 | — |
Summary
The purpose of this research study is to evaluate and improve a rapid COVID-19 test. The test is designed to identify people who are most contagious and likely to spread the virus to others. This test will be performed at various locations in the Madison 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. Results of potential findings of clinical significance will be communicated to the participants by a physician with appropriate expertise on the study team. Individuals with a potential finding of clinical significance will be encouraged to self-isolate and obtain a diagnostic test at their earliest convenience. No results will be given if the test is negative. If the participant consents, advanced molecular testing such as PCR or viral sequencing can be done and results can be shared via online databases, presentations and publications along with the date, site and county of collection to help facilitate tracking the spread of the virus.
Eligibility Criteria
Inclusion Criteria
- Willing to provide informed consent
- Willing to provide informed consent and spit into a vessel
- Individuals at least 5 years of age and have a parent or legal guardian present to consent if under 18 years
- Adult participants must have decision-making capacity to provide consent on their own behalf.
- Participants must be able to speak English
Exclusion Criteria
- Under 18 years of age with no parent or legal guardian present or under the age of 5 yrs
- 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
Data sourced from ClinicalTrials.gov (NCT04460690). 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.