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

NCT04568122 | Completed Results FDA Device

• 1 other identifier: 58629
• Study Type: interventional
• Target: 1,277
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• 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

• Number of Positive Home Saliva Tests as Determined by the Patient

  Validity Outcome.

  Up to 5 days per participant

Secondary Outcomes (6)

• Participant-rated Confidence in Interpreting Results

  Up to 5 days per participant

• Participant-rated Ease of Use

  Up to 5 days per participant

• Number of Participants That Called Technical Support

  Up to 5 days per participant

• Sample Integrity

  Up to 5 days per participant

• Sensitivity of Sample Test Kit

  Up to 5 days per participant

Study Arms (1)

Saliva test

EXPERIMENTAL

Participants perform each test assay, noting the results for comparison by technician, and completing survey questionnaires.

Device: Saliva test kit

Interventions

Saliva test kit DEVICE

Kit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus.

Also known as: SnapDx

Saliva test

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• BioBox: collaborator

Study Sites (2)

SHC Valley Care

Pleasanton, California, 94566, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Related Links

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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Manu Prakash, PhD
• Organization: Stanford University BioEngineering

manup@stanford.edu

(650) 725-3731

Study Officials

• Manu Prakash, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Manisha Desai, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Euan A Ashley, MRCP, DPhil

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrollment is to a single group. Specific eligibility criteria apply depending on whether the participant is a hospitalized patient, in high-risk or infected population, or low-risk population

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: September 29, 2020
• Study Start: November 20, 2020
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2022
• Last Updated: January 10, 2024
• Results First Posted: January 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)