NCT04568122

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

Completed NA Results posted Last updated 10 January 2024

What this trial tests

NA trial testing Saliva test kit in Covid19 in 1,277 participants. Completed in 10 December 2022.

Timeline

20 November 2020

Primary endpoint
10 December 2022

10 December 2022

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	1,277
Start date	20 November 2020
Primary completion	10 December 2022
Estimated completion	10 December 2022
Sites	2 locations across United States

Drugs / interventions tested

• Saliva test kit

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Stanford University

Who can join

2 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability Primary · Up to 5 days per participant

Feasibility Outcome. Discrepancy in interpretation of colormetric readout by participant versus by technician via photo. Passed test = void of manufacturing or user error.

Total passed tests

Group	Value	95% CI
Saliva Test - First Distribution	52
Saliva Test - Second Distribution	69
Saliva Test - Third Distribution	97

Matching interpretation

Group	Value	95% CI
Saliva Test - First Distribution	27
Saliva Test - Second Distribution	67
Saliva Test - Third Distribution	93

Number of Positive Home Saliva Tests as Determined by the Patient Primary · Up to 5 days per participant

Validity Outcome.

Group	Value	95% CI
Saliva Test - First Distribution	NA
Saliva Test - Second Distribution	NA
Saliva Test - Third Distribution	NA

Participant-rated Confidence in Interpreting Results Secondary · Up to 5 days per participant

Validity Outcome (ease of interpretation). Number of participants responding by category when asked to provide a rating on being "Confident in Interpreting Results."

Strongly agree

Group	Value	95% CI
Saliva Test - Third Distribution	53

Agree

Group	Value	95% CI
Saliva Test - Third Distribution	61

Somewhat agree

Group	Value	95% CI
Saliva Test - Third Distribution	9

Neither agree nor disagree

Group	Value	95% CI
Saliva Test - Third Distribution	2

Somewhat disagree

Group	Value	95% CI
Saliva Test - Third Distribution	3

Disagree

Group	Value	95% CI
Saliva Test - Third Distribution	3

Strongly disagree

Group	Value	95% CI
Saliva Test - Third Distribution	0

Participant-rated Ease of Use Secondary · Up to 5 days per participant

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."

Strongly agree

Group	Value	95% CI
Saliva Test - First Distribution	0
Saliva Test - Second Distribution	5
Saliva Test - Third Distribution	13

Agree

Group	Value	95% CI
Saliva Test - First Distribution	6
Saliva Test - Second Distribution	22
Saliva Test - Third Distribution	52

Somewhat agree

Group	Value	95% CI
Saliva Test - First Distribution	7
Saliva Test - Second Distribution	10
Saliva Test - Third Distribution	39

Neither agree nor disagree

Group	Value	95% CI
Saliva Test - First Distribution	2
Saliva Test - Second Distribution	4
Saliva Test - Third Distribution	4

Somewhat disagree

Group	Value	95% CI
Saliva Test - First Distribution	8
Saliva Test - Second Distribution	12
Saliva Test - Third Distribution	18

Disagree

Group	Value	95% CI
Saliva Test - First Distribution	3
Saliva Test - Second Distribution	6
Saliva Test - Third Distribution	5

Strongly disagree

Group	Value	95% CI
Saliva Test - First Distribution	3
Saliva Test - Second Distribution	5
Saliva Test - Third Distribution	0

Number of Participants That Called Technical Support Secondary · Up to 5 days per participant

Feasibility Outcome (ease of use). Number of participants that called technical support, by reason (e.g., processing was not possible due to broken part).

Group	Value	95% CI
Saliva Test - First Distribution	0
Saliva Test - Second Distribution	0

Sample Integrity Secondary · Up to 5 days per participant

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.

Sufficient sample

Group	Value	95% CI
Saliva Test - First Distribution	78
Saliva Test - Third Distribution	131

Significant presence of bubbles

Group	Value	95% CI
Saliva Test - First Distribution	25
Saliva Test - Third Distribution	50

Sensitivity of Sample Test Kit Secondary · Up to 5 days per participant

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.

Group	Value	95% CI
Positive Saliva Collection	4

Specificity of Sample Test Kit Secondary · Up to 5 days per participant

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.

Group	Value	95% CI
Negative Sample Analysis	15
Negative Saliva Collection	10
All Samples	25

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.