Covid19NCT04568122

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

A study testing Saliva test kit in people with Covid19, run by Stanford University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: Saliva test kit
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,277 participants
Where: 2 sitesUnited States
Study dates: 20 Nov 2020to 10 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

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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

Who cannot join

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

Show all 10Show fewer

Low-risk population
Participants with prior confirmed SARS-CoV-2 infection
Participants who have color blindness
Participants unable to operate the SnapDx device

Trial locations and contacts

2 sites in 1 country.

United States2 sites

SHC Valley Care
Pleasanton, California, 94566
Stanford University
Stanford, California, 94305

Other trials in United States

About this study

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
Being tested: Saliva test kit
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Saliva test kitDevice
Also called SnapDx
Kit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus.

Study groups in NCT04568122
Study group	Role	What they receive
Saliva test	Experimental	Participants perform each test assay, noting the results for comparison by technician, and completing survey questionnaires. Receives: Device: Saliva test kit

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 5 days per participant
Number of Positive Home Saliva Tests as Determined by the Patient
Validity Outcome.
Measured: Up to 5 days per participant

Secondary outcomes (6)

Participant-rated Confidence in Interpreting Results
Validity Outcome (ease of interpretation). Number of participants responding by category when asked to provide a rating on being "Confident in Interpreting Results."
Measured: Up to 5 days per participant
Participant-rated Ease of Use
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."
Measured: Up to 5 days per participant
Number of Participants That Called Technical Support
Feasibility Outcome (ease of use). Number of participants that called technical support, by reason (e.g., processing was not possible due to broken part).
Measured: Up to 5 days per participant
Sample Integrity
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.
Measured: Up to 5 days per participant
Sensitivity of Sample Test Kit
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.
Measured: Up to 5 days per participant
Specificity of Sample Test Kit
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.
Measured: Up to 5 days per participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 202010 Dec 2022

First posted29 Sep 2020
Study start20 Nov 2020
Primary completion10 Dec 2022
Study completion10 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 1,277 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04568122
Sponsor's protocol ID: 58629
Status last verified: Dec 2023
First submitted: 25 Sep 2020
Last updated: 10 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rapid Turnaround, Home-based Saliva Testing for COVID-19
ClinicalTrials.gov ID: NCT04568122
Acronym / sponsor ID: 58629
Conditions: Covid19
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,277 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: BioBox
Study start: 20 Nov 2020 (actual)
Primary completion: 10 Dec 2022 (actual)
Study completion: 10 Dec 2022 (actual)
First posted: 29 Sep 2020 (actual)
Results: Posted 10 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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

Arm	Type	Receives
Saliva test	Experimental	Device: Saliva test kitParticipants perform each test assay, noting the results for comparison by technician, and completing survey questionnaires.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

Hospitalized patients
High-risk/positive population
Low-risk population

Key exclusion criteria (10 listed)

All participants:
High-risk/positive population
Low-risk population

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Saliva test kitAlso: SnapDxKit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus.	Device	Saliva test

Primary outcome

Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability
Time frame: 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.
Number of Positive Home Saliva Tests as Determined by the Patient
Time frame: Up to 5 days per participant
Validity Outcome.

6 secondary outcomes

Participant-rated Confidence in Interpreting Results
Time frame: Up to 5 days per participant
Participant-rated Ease of Use
Time frame: Up to 5 days per participant
Number of Participants That Called Technical Support
Time frame: Up to 5 days per participant
Sample Integrity
Time frame: Up to 5 days per participant
Sensitivity of Sample Test Kit
Time frame: Up to 5 days per participant
Specificity of Sample Test Kit
Time frame: Up to 5 days per participant

Results and safety

Results posted to the registry on 10 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saliva Test - First Distribution	94	46
Saliva Test - Second Distribution	112	68
Saliva Test - Third Distribution	135	131
Positive Saliva Collection	9	9
Negative Saliva Collection	3	3

Primary outcome: Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability

Time frame: Up to 5 days per participant. Count of units. Unit: Completed tests

Measure	Saliva Test - First Distribution n = 46	Saliva Test - Second Distribution n = 68	Saliva Test - Third Distribution n = 131
Total passed tests	52	69	97
Matching interpretation	27	67	93

Population analysed: Data were collected from the Saliva Test - First, Second, and Third Distribution groups only. Participants who completed at least one test are included in the analysis.

Primary outcome: Number of Positive Home Saliva Tests as Determined by the Patient

Time frame: Up to 5 days per participant. Count of units. Unit: Completed tests

Measure	Saliva Test - First Distribution n = 46	Saliva Test - Second Distribution n = 68	Saliva Test - Third Distribution n = 131
Value	NA	NA	NA

Population analysed: Data were collected from the Saliva Test - First, Second, and Third Distribution groups only. Participants who completed at least one test are included in the analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Average approximately 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saliva Test - First Distribution	0 of 94 (0%)	0 of 94 (0%)	0 of 94
Saliva Test - Second Distribution	0 of 112 (0%)	0 of 112 (0%)	0 of 112
Saliva Test - Third Distribution	0 of 135 (0%)	0 of 135 (0%)	0 of 135
Positive Saliva Collection	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Negative Saliva Collection	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Not yet recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manu Prakash, PhD principal investigator

Stanford University

Manisha Desai, PhD principal investigator

Stanford University

Euan A Ashley, MRCP, DPhil principal investigator

Stanford University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Saliva test kit in people with Covid19, run by Stanford University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability (time frame: Up to 5 days per participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04568122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.