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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
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
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Saliva test 		Participants perform each test assay, noting the results for comparison by technician, and completing survey questionnaires.
  • Device: Saliva test kit
    Kit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus.
    Other names:
    • SnapDx

Recruiting Locations

More Details

NCT ID
NCT04568122
Status
Completed
Sponsor
Stanford University

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.