Clinical trial NCT04579549: Repeat Testing for SARS-CoV-2
Official title: Repeat Saliva Testing for SARS-CoV-2 Using RT-LAMP Assay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Sars-CoV-2
Keywords: rapid detection
assay
coronavirus
saliva
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-10-08
Enrollment: 464
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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 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. The investigators are also looking to see if it can be simplified so minimally trained staff can perform it successfully. 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 polymerase chain reaction (PCR) viral load tests, viral sequencing or other optimizing experiments can be done. Results of the viral sequencing 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. Study data will be shared via open research portals and online dashboards.

Participants with a potential finding of clinical significance will be contacted by phone approximately 1 week after the finding and asked the following questions. There will be 2 attempts at obtaining answers.

Question 1: Did you self-isolate after receiving the clinician's notification? Question 2: Did you receive a follow-up diagnostic test?

To assess whether or not the assay can be simplified so that minimally trained personnel can perform it, the investigators will perform proficiency tests with inactivated virus with newly trained staff which will help us optimize and refine the protocol. Successfully training staff achieve "proficiency" by correctly differentiating blinded positive and negative samples. This is how the investigators will assess the simplicity of the assay. For example, if a round of proficiency testing results in only 2/6 trainees achieving proficiency on their first try, that would suggest that the assay still has reducible complexity.

Tolerability of frequent testing could be done by keeping track of the interval between sample donations. Does the participant give a sample on a regular basis? Did they register but not donate a sample until weeks later? The study team will actively look for improved ways to assess this objective as we gather more data at these testing sites.

Relevant feasibility study is documented separately in NCT04460690.

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

Primary outcomes:
measure: Number of Participant Phone Surveys Conducted
timeFrame: up to 1 week after test
measure: Number of Minimally Trained Personnel Who Achieve Assay Proficiency
timeFrame: up to 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David O'Connor, PhD
role: PRINCIPAL_INVESTIGATOR
References: