Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04460690 |
| Other study ID # |
2020-0855 |
| Secondary ID |
A536300SMPH/PATH |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 13, 2020 |
| Est. completion date |
March 31, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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 (~ΒΌ 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.
