Trial Outcomes & Findings for Rapid, Onsite COVID-19 Detection (NCT NCT04460690)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

93 participants

Primary outcome timeframe

15 minutes

Results posted on

2022-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	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. Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2
Overall Study STARTED	93
Overall Study Community Participants	83
Overall Study Investigator Participants	10
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participant age was not collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rapid Onsite COVID-29 Testing - Investigators n=10 Participants 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	Rapid Onsite COVID-29 Testing - Participants n=83 Participants 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 n=93 Participants Total of all reporting groups
Age, Customized	—	—	0 Participants Participant age was not collected.
Sex/Gender, Customized any gender	—	—	0 Participants Participant gender was not collected.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 Participants n=10 Participants	83 Participants n=83 Participants	93 Participants n=93 Participants

PRIMARY outcome

Timeframe: 15 minutes

Population: 3692 samples were collected from 93 participants.

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.

Outcome measures

Outcome measures
Measure	Rapid Onsite COVID-29 Testing n=3692 samples 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 The team members that participated in the testing
Number of Samples Tested	3692 samples	—

PRIMARY outcome

Timeframe: up to 2 months

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

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.

Outcome measures

Outcome measures
Measure	Rapid Onsite COVID-29 Testing n=83 Participants 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 n=10 Participants The team members that participated in the testing
Safety: Number of Participants Who Tested Positive for COVID-19	16 Participants	0 Participants

Adverse Events

Rapid Onsite COVID-29 Testing - Community Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rapid Onsite COVID-29 Testing - Investigator Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristi Hall

University of Wisconsin - Madison

Phone: 608-890-0844

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place