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

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04568122
Collaborator
(none)
3,015
Enrollment
2
Locations
1
Arm
23.4
Anticipated Duration (Months)
1507.5
Patients Per Site
64.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Saliva test kit
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3015 participants
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 populationEnrollment 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
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Rapid Turnaround, Home-based Saliva Testing for COVID-19
Actual Study Start Date :
Nov 20, 2020
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. An indicator for discrepancy in interpretation of findings by participant versus by technician via photo (interrater reliability) [Up to 5 days per participant]

      Primary Feasibility Outcome

    2. An indicator for whether the home saliva test is positive as determined by the patient (to assess sensitivity and specificity by the patient) [Up to 5 days per participant]

      Primary Validity Outcome

    Secondary Outcome Measures

    1. An indicator for ambiguous findings as measured by percent confidence (if < 80% confident) in interpretation of results by participant and by technician (ease of interpretation) [Up to 5 days per participant]

      Secondary Feasibility Outcome

    2. An indicator that the participant appropriately followed instructions for using the kit (≥ 80% confident) (ease of use) [Up to 5 days per participant]

      Secondary Feasibility Outcome

    3. An indicator for whether participant called technical support and by reason (e.g., processing was not possible due to broken part) (ease of use) [Up to 5 days per participant]

      Secondary Feasibility Outcome

    4. An indicator by participant that the sample was sufficient and reached the indicated line for sample integrity (sample integrity) [Up to 5 days per participant]

      Secondary Feasibility Outcome

    5. An indicator for whether the home saliva test is positive as determined by the technician (to assess sensitivity and specificity by the technician) [Up to 5 days per participant]

      Secondary Validity Outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SHC Valley Care Pleasanton California United States 94566
    2 Stanford University Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Manu Prakash, PhD, Stanford University
    • Principal Investigator: Manisha Desai, PhD, Stanford University
    • Principal Investigator: Euan A Ashley, MRCP, DPhil, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT04568122
    Other Study ID Numbers:
    • 58629
    First Posted:
    Sep 29, 2020
    Last Update Posted:
    Apr 18, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Apr 18, 2022