Back to resultsRapid Turnaround, Home-based Saliva Testing for COVID-19
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saliva test kit
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19
Eligibility Criteria
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
Sites / Locations
- SHC Valley Care
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Saliva test
Arm Description
Participants perform each test assay, noting the results for comparison by technician, and completing survey questionnaires.
Outcomes
Primary Outcome Measures
An indicator for discrepancy in interpretation of findings by participant versus by technician via photo (interrater reliability)
Primary Feasibility Outcome
An indicator for whether the home saliva test is positive as determined by the patient (to assess sensitivity and specificity by the patient)
Primary Validity Outcome
Secondary Outcome Measures
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)
Secondary Feasibility Outcome
An indicator that the participant appropriately followed instructions for using the kit (≥ 80% confident) (ease of use)
Secondary Feasibility Outcome
An indicator for whether participant called technical support and by reason (e.g., processing was not possible due to broken part) (ease of use)
Secondary Feasibility Outcome
An indicator by participant that the sample was sufficient and reached the indicated line for sample integrity (sample integrity)
Secondary Feasibility Outcome
An indicator for whether the home saliva test is positive as determined by the technician (to assess sensitivity and specificity by the technician)
Secondary Validity Outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04568122
Brief Title
Rapid Turnaround, Home-based Saliva Testing for COVID-19
Official Title
Rapid Turnaround, Home-based Saliva Testing for COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
December 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
1278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saliva test
Arm Type
Experimental
Arm Description
Participants perform each test assay, noting the results for comparison by technician, and completing survey questionnaires.
Intervention Type
Device
Intervention Name(s)
Saliva test kit
Other Intervention Name(s)
SnapDx
Intervention Description
Kit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus.
Primary Outcome Measure Information:
Title
An indicator for discrepancy in interpretation of findings by participant versus by technician via photo (interrater reliability)
Description
Primary Feasibility Outcome
Time Frame
Up to 5 days per participant
Title
An indicator for whether the home saliva test is positive as determined by the patient (to assess sensitivity and specificity by the patient)
Description
Primary Validity Outcome
Time Frame
Up to 5 days per participant
Secondary Outcome Measure Information:
Title
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)
Description
Secondary Feasibility Outcome
Time Frame
Up to 5 days per participant
Title
An indicator that the participant appropriately followed instructions for using the kit (≥ 80% confident) (ease of use)
Description
Secondary Feasibility Outcome
Time Frame
Up to 5 days per participant
Title
An indicator for whether participant called technical support and by reason (e.g., processing was not possible due to broken part) (ease of use)
Description
Secondary Feasibility Outcome
Time Frame
Up to 5 days per participant
Title
An indicator by participant that the sample was sufficient and reached the indicated line for sample integrity (sample integrity)
Description
Secondary Feasibility Outcome
Time Frame
Up to 5 days per participant
Title
An indicator for whether the home saliva test is positive as determined by the technician (to assess sensitivity and specificity by the technician)
Description
Secondary Validity Outcome
Time Frame
Up to 5 days per participant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manu Prakash, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manisha Desai, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Euan A Ashley, MRCP, DPhil
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SHC Valley Care
City
Pleasanton
State/Province
California
ZIP/Postal Code
94566
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.snapdx.org/
Description
https://www.snapdx.org/ (for more information and how to enroll)
Learn more about this trial
Rapid Turnaround, Home-based Saliva Testing for COVID-19
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