Rapid, Onsite COVID-19 Detection

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT04460690
• Collaborator: National Institutes of Health (NIH) (NIH), AIDS Vaccine Research Lab (Other)
• Enrollment: 93
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.6
• Patients Per Site Per Month: 10.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Sars-CoV2	Device: Rapid Onsite COVID-19 Detection	N/A

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 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Rapid, Onsite COVID-19 Detection
• Actual Study Start Date: Jul 13, 2020
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rapid Onsite COVID-29 Testing 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

Outcome Measures

Primary Outcome Measures

1. Number of Samples Tested [15 minutes]

   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.

2. Safety: Number of Participants Who Tested Positive for COVID-19 [up to 2 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin	Madison	Wisconsin	United States	53711

Sponsors and Collaborators

• University of Wisconsin, Madison
• National Institutes of Health (NIH)
• AIDS Vaccine Research Lab

Investigators

• Principal Investigator: David O'Connor, PhD, University of Wisconsin, Madison

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 30, 2020
• Informed Consent Form - Sep 8, 2020

More Information

Additional Information:

• Dave O'Connor's Lab

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT04460690
• Other Study ID Numbers: 2020-0855; A536300; SMPH/PATHOL-LAB MED/ANAT PATH; Protocol Version 8/30/2020; 5P51OD011106-59
• First Posted: Jul 7, 2020
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by University of Wisconsin, Madison: rapid detection; assay; saliva; coronavirus
• Additional relevant MeSH terms: COVID-19

Study Results

Participant Flow

Arm/Group Title	Rapid Onsite COVID-29 Testing
Arm/Group Description	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. Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2
Period Title: Overall Study
STARTED	93
Community Participants	83
Investigator Participants	10
COMPLETED	93
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Rapid Onsite COVID-29 Testing - Investigators	Rapid Onsite COVID-29 Testing - Participants	Total
Arm/Group Description	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. Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2	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. Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2	Total of all reporting groups
Overall Participants	10	83	93
Age, Customized (Count of Participants)
Count of Participants [Participants]	0 0%
Sex/Gender, Customized (Count of Participants)
any gender	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	10 100%	83 100%	93 100%

Outcome Measures

1. Primary Outcome

Title	Number of Samples Tested
Description	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

Outcome Measure Data

Analysis Population Description

3692 samples were collected from 93 participants.

Arm/Group Title	Rapid Onsite COVID-29 Testing
Arm/Group Description	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. Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2
Measure Participants	93
Measure samples	3692
Count of Units [samples]	3692

2. Primary Outcome

Title	Safety: Number of Participants Who Tested Positive for COVID-19
Description	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

Outcome Measure Data

Analysis Population Description

The participants included people from the community and team members performing the tests.

Arm/Group Title	Community Participants	Investigator Participants
Arm/Group Description	Community participants that gave samples	The team members that participated in the testing
Measure Participants	83	10
Count of Participants [Participants]	16 160%	0 0%

Adverse Events

Time Frame	Participants were not monitored for adverse events during sample collection.
Adverse Event Reporting Description	Participants were able to donate a saliva sample using two different methods. The first being a drop box with no interaction with the study team (saliva samples were collected off site) and the second being an in person saliva sample collection at designate dates and times. Participants were not monitored for adverse events during sample collection.
Arm/Group Title	Rapid Onsite COVID-29 Testing - Community Participants		Rapid Onsite COVID-29 Testing - Investigator Participants
Arm/Group Description	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. Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2		Investigator 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. Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2
All Cause Mortality
	Rapid Onsite COVID-29 Testing - Community Participants		Rapid Onsite COVID-29 Testing - Investigator Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Rapid Onsite COVID-29 Testing - Community Participants		Rapid Onsite COVID-29 Testing - Investigator Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Rapid Onsite COVID-29 Testing - Community Participants		Rapid Onsite COVID-29 Testing - Investigator Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.