An interventional study of Rapid Onsite COVID-19 Detection in COVID-19 and Sars-CoV2, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2022-01-20.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Diagnostic
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.
Virtually all COVID-19 RNA assays require centralized laboratories. Samples collected in locations including public testing sites, workplaces, nursing homes, and residential housing are transported to centralized laboratories for testing, leading to lengthy delays in results reporting. The window of maximal contagiousness is thought to be only a few days, so these delays create the risk of excess transmission. Current testing methods are painful, which encourages testing hesitancy. Rapid, onsite detection of SARS-CoV-2 RNA from non-invasive saliva could overcome these issues and provide a pathway to high-throughput detection of people at the greatest risk of SARS-CoV-2 transmission but the logistics of such a testing program require real-world prototyping.
The investigators have developed 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. This assay is not diagnostic for SARS-CoV-2; instead, it specifically identifies saliva samples that have high amounts of viral RNA that are correlated with live virus shedding. Many samples that would be identified as SARS-CoV-2 by diagnostic qRT-PCR would be negative with this saliva assay. Conversely, detection of RNA in saliva is a potential finding of clinical significance, so participants with that result will be contacted by a medical professional to discuss potential follow-up with their own health care provider, including a possible independent diagnostic testing.
Because the assay requires no specialized equipment, it can be performed at the site of sample collection using a portable laboratory that fits in the backseat of a car. The prototype testing will take place in a variety of settings that may include parking lots, workplaces, nursing homes and residential housing. Participants will be asked to consent to provide a saliva sample that will be tested for SARS-CoV-2 RNA levels consistent with live virus shedding. The consent document will explicitly state that this is not a diagnostic test for SARS-CoV-2 but that a potential finding of clinical significance should be discussed with a medical professional. Participants can opt-out of receiving any results at the time of consent and can provide samples for the sole purpose of contributing to community surveillance and assay development. Paper consent forms will be reviewed and signed and held by team members in a secure location (locked box at the collection site) until taken back to the AIDS Vaccine Research Laboratory for storage. Participants will then spit into a coded vessel (e.g., cup or tube). Samples should be at least 1ml (\~¼ teaspoon) and will be assayed for the presence of SARS-CoV-2 RNA using the aforementioned detection assay; the presence of high concentrations of SARS-CoV-2 RNA is indicated by a colorimetric change from pink to yellow/orange.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 93 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Community 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.
Device: Rapid Onsite COVID-19 Detection
saliva assay test for high concentrations of SARS-CoV-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.
Time frame: 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.
Time frame: up to 2 months
| Milestone | Rapid Onsite COVID-29 Testing |
|---|---|
| Started | 93 |
| Community participants | 83 |
| Investigator participants | 10 |
| Completed | 93 |
| Not completed | 0 |
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.
| samples | Rapid Onsite COVID-29 Testing |
|---|---|
| Number of Samples Tested | 3692 |
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.
| Participants | Community Participants | Investigator Participants |
|---|---|---|
| Safety: Number of Participants Who Tested Positive for COVID-19 | 16 | 0 |
Collected over Participants were not monitored for adverse events during sample collection.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rapid Onsite COVID-29 Testing - Community Participants | — | — | — |
| Rapid Onsite COVID-29 Testing - Investigator Participants | — | — | — |
| Age, Customized(Participants) | Rapid Onsite COVID-29 Testing - Investigators | Rapid Onsite COVID-29 Testing - Participants | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Sex/Gender, Customized(Participants) | Rapid Onsite COVID-29 Testing - Investigators | Rapid Onsite COVID-29 Testing - Participants | Total |
|---|---|---|---|
| any gender | — | — | 0 |
| Race and Ethnicity Not Collected(Participants) | Rapid Onsite COVID-29 Testing - Investigators | Rapid Onsite COVID-29 Testing - Participants | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Rapid Onsite COVID-29 Testing - Investigators | Rapid Onsite COVID-29 Testing - Participants | Total |
|---|---|---|---|
| United States | 10 | 83 | 93 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison