Trial Outcomes & Findings for Repeat Testing for SARS-CoV-2 (NCT NCT04579549)

NCT ID: NCT04579549

Last Updated: 2022-01-20

Results Overview

All participants with a potential finding of clinical significance (a result indicated the possible presences of SARS-CoV-2 in the saliva sample) will be contacted by phone approximately 1 week after the finding and asked if they received a follow-up diagnostic test and if they self-isolated after receiving the clinician's notification. There will be 2 attempts at obtaining answers. The investigators hope to receive at least 10 survey responses. This is a measure of surveillance feasibility.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 464 participants
• Primary outcome timeframe: up to 1 week after test
• Results posted on: 2022-01-20

Participant Flow

Participant milestones

Measure	Repeat Testing for SARS-CoV-2 Anyone over the age of 5yrs old with consent to provide a saliva sample for SARS-CoV-2 assay will be eligible to participate. Assay takes 20 minutes. Saliva Assay: saliva assay test for high concentrations of SARS-CoV-2
Overall Study STARTED	464
Overall Study Number of Individuals Trained In COVID-19 Assay	11
Overall Study COMPLETED	464
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participant age was not collected.

Baseline characteristics by cohort

Measure	Repeat Testing for SARS-CoV-2 n=464 Participants Anyone over the age of 5yrs old with consent to provide a saliva sample for SARS-CoV-2 assay will be eligible to participate. Assay takes 20 minutes. Saliva Assay: saliva assay test for high concentrations of SARS-CoV-2
Region of Enrollment United States	464 participants n=464 Participants

PRIMARY outcome

Timeframe: up to 1 week after test

Population: 3 participants had a potential finding of clinical significance and were contacted.

All participants with a potential finding of clinical significance (a result indicated the possible presences of SARS-CoV-2 in the saliva sample) will be contacted by phone approximately 1 week after the finding and asked if they received a follow-up diagnostic test and if they self-isolated after receiving the clinician's notification. There will be 2 attempts at obtaining answers. The investigators hope to receive at least 10 survey responses. This is a measure of surveillance feasibility.

Outcome measures

Measure	Repeat Testing for SARS-CoV-2 n=3 Participants Anyone over the age of 5yrs old with consent to provide a saliva sample for SARS-CoV-2 assay will be eligible to participate. Assay takes 20 minutes. Saliva Assay: saliva assay test for high concentrations of SARS-CoV-2
Number of Participant Phone Surveys Conducted	3 phone surveys

PRIMARY outcome

Timeframe: up to 1 day

Successfully trained staff achieve "proficiency" by correctly differentiating blinded positive and negative samples. This is measure of the simplicity of the assay. Training personnel will take place over several months, proficiency should be determined within the same day as personnel are trained.

Outcome measures

Measure	Repeat Testing for SARS-CoV-2 n=11 Participants Anyone over the age of 5yrs old with consent to provide a saliva sample for SARS-CoV-2 assay will be eligible to participate. Assay takes 20 minutes. Saliva Assay: saliva assay test for high concentrations of SARS-CoV-2
Number of Minimally Trained Personnel Who Achieve Assay Proficiency	11 Participants

Adverse Events

Repeat Testing for SARS-CoV-2

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: klhall1@wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place