Rapid Turnaround, Home-based Saliva Testing for COVID-19

Covid19 Clinical Trial

Official title:

Rapid Turnaround, Home-based Saliva Testing for COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568122
• Other study ID #: 58629
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: December 10, 2022

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to demonstrate the feasibility and validity of a saliva based home surveillance monitoring test for SARS-CoV-2 infection.

Participants will be asked to carry out as many tests as are included in the bag they are provided, on a daily basis until they are used up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1277
• Est. completion date: December 10, 2022
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized patients

• Hospitalized at Stanford Health Care for COVID-related complications and tested positive for SARS-CoV-2 with a PCR-based test

• Able to understand and consent to study and with a clinical trajectory likely to be consistent with multi-day participation

• High-risk/positive population

• Seeking testing for suspected COVID or a participant in a study of COVID-positive outpatients

• Own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos.

• Willing to participate in the study for 6 months

• Low-risk population

• Own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos.

• Willing to participate in the study for 6 months

Exclusion Criteria:

• All participants:

• Participants with salivary gland dysfunction (including patients with Sjogren's disease or those with xerostomia associated with lupus or rheumatoid arthritis)

• Participants will not be eligible if they identify any reason they are unable to participate in the study

• High-risk/positive population

• Participants who have color blindness

• Participants unable to operate the SnapDx device

• Low-risk population

• Participants with prior confirmed SARS-CoV-2 infection

• Participants who have color blindness

• Participants unable to operate the SnapDx device

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Device:
• Saliva test kit
Kit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus.

Locations

Country	Name	City	State
United States	SHC Valley Care	Pleasanton	California
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	BIOBOX

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability	Feasibility Outcome. Discrepancy in interpretation of colormetric readout by participant versus by technician via photo. Passed test = void of manufacturing or user error.	Up to 5 days per participant
Primary	Number of Positive Home Saliva Tests as Determined by the Patient	Validity Outcome.	Up to 5 days per participant
Secondary	Participant-rated Confidence in Interpreting Results	Validity Outcome (ease of interpretation). Number of participants responding by category when asked to provide a rating on being "Confident in Interpreting Results."	Up to 5 days per participant
Secondary	Participant-rated Ease of Use	Validity Outcome (ease of use). Number of participants responding by category when asked to provide a rating on SnapDx being "Easy to Learn to Use."	Up to 5 days per participant
Secondary	Number of Participants That Called Technical Support	Feasibility Outcome (ease of use). Number of participants that called technical support, by reason (e.g., processing was not possible due to broken part).	Up to 5 days per participant
Secondary	Sample Integrity	Feasibility Outcome. The participants were asked to determine whether the saliva sample filled up to the indicated line, and if there were bubbles present as a measure of sample integrity.	Up to 5 days per participant
Secondary	Sensitivity of Sample Test Kit	Validity Outcome. Analysis of saliva samples provided by participants and run through sample test kit by study lab. Sensitivity = number of true positives out of the positive tests run. Samples may have been split and run through more than one test.	Up to 5 days per participant
Secondary	Specificity of Sample Test Kit	Validity Outcome. Analysis of saliva samples provided by participants and run through sample test kit by study lab. Specificity = number of true negatives out of negative tests run. Samples may have been split and run through more than one test.	Up to 5 days per participant

External Links

•   https://www.snapdx.org/ (for more information and how to enroll)