Clinical trial NCT04568122: Rapid Turnaround, Home-based Saliva Testing for COVID-19
Official title: Rapid Turnaround, Home-based Saliva Testing for COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: BioBox
First posted: 2020-09-29
Enrollment: 1277
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.


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

Primary outcomes:
measure: Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability
timeFrame: Up to 5 days per participant
measure: Number of Positive Home Saliva Tests as Determined by the Patient
timeFrame: Up to 5 days per participant
Secondary outcomes:
measure: Participant-rated Confidence in Interpreting Results
timeFrame: Up to 5 days per participant
measure: Participant-rated Ease of Use
timeFrame: Up to 5 days per participant
measure: Number of Participants That Called Technical Support
timeFrame: Up to 5 days per participant
measure: Sample Integrity
timeFrame: Up to 5 days per participant
measure: Sensitivity of Sample Test Kit
timeFrame: Up to 5 days per participant
measure: Specificity of Sample Test Kit
timeFrame: Up to 5 days per participant
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: SHC Valley Care
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Manu Prakash, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Manisha Desai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Euan A Ashley, MRCP, DPhil
role: PRINCIPAL_INVESTIGATOR
References: