Rapid, Onsite COVID-19 Detection
5 other identifiers
interventional
93
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedResults Posted
Study results publicly available
January 19, 2022
CompletedJanuary 20, 2022
January 1, 2022
9 months
July 6, 2020
December 23, 2021
January 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Samples Tested
samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory.
15 minutes
Safety: Number of Participants Who Tested Positive for COVID-19
Feasibility is determined when at least 10000 samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory. This testing protocol will be considered safe if COVID-19 rates of those performing the tests do not significantly exceed those of the communities in which the tests are being performed.
up to 2 months
Study Arms (1)
Rapid Onsite COVID-29 Testing
EXPERIMENTALCommunity participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.
Interventions
saliva assay test for high concentrations of SARS-CoV-2
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- National Institutes of Health (NIH)collaborator
- AIDS Vaccine Research Labcollaborator
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53711, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kristi Hall
- Organization
- University of Wisconsin - Madison
Study Officials
- PRINCIPAL INVESTIGATOR
David O'Connor, PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2020
First Posted
July 7, 2020
Study Start
July 13, 2020
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
January 20, 2022
Results First Posted
January 19, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data from this study may be requested from other researchers 7 years after the completion of the primary endpoint by contacting David O'Connor at the University of Wisconsin - Madison.
Participants will consent to having their data (not their name) and viral sequences shared with the public via manuscripts, presentations and online databases; the study team will share that with other researchers when needed. Samples can be shared with UW researchers internally and non UW researchers through the Material Transfer Agreement process.