Back to resultsCOVID-19 Tests With Saliva Specimens
Primary Purpose
Covid19
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saliva collection
Sponsored by
About this trial
This is an interventional screening trial for Covid19
Eligibility Criteria
Inclusion Criteria:
Persons referred for COVID-19 testing including those with COVID-19 symptoms and/or a suspected SARS-COV-2 infection or undergoing surveillance testing and
- Is able to give informed consent
- Is able to understand oral or written instructions, and
- Is able to mentally and physically perform self-collection of saliva using the provided collection device.
Exclusion Criteria:
- - Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Employees of Paradigm lab and the assisted living facilities involved in the study
- Members of other vulnerable populations
Sites / Locations
- Paradigm Laboratories
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Saliva and NP paired specimen collection
Arm Description
Outcomes
Primary Outcome Measures
The clinical evaluation of saliva as specimen for COVID-19 molecular test
We will evaluate the positive and negative agreement of saliva with nasopharyngeal swab as specimens for COVID-19 molecular test.
Secondary Outcome Measures
Full Information
NCT ID
NCT04567953
First Posted
September 25, 2020
Last Updated
September 25, 2020
Sponsor
Paradigm Laboratories LLC
1. Study Identification
Unique Protocol Identification Number
NCT04567953
Brief Title
COVID-19 Tests With Saliva Specimens
Official Title
COVID-19 Tests With Saliva Specimens
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Anticipated)
Study Completion Date
June 27, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paradigm Laboratories LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Upper respiratory swabs, such as the nasopharyngeal (NP) swab, have so far been major specimen sources used for the SARS-COV-2 molecular test. However, due to the discomfort and invasiveness of NP collection, and the expense of personal protective equipment, alternative sampling sources such as saliva are desired. The purpose of this proposed study is: 1) to examine whether saliva can be used as an specimen for the SARS-COV-2 molecular test; 2) to test if gingival crevicular fluids is a reliable specimen for the SARS-COV-2 antibodies.
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
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Saliva and NP paired specimen collection
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Saliva collection
Intervention Description
Use Spectrum Solutions SDNA1000 or Orasure collection kit or dry tube to collect 1-3 ml of saliva
Primary Outcome Measure Information:
Title
The clinical evaluation of saliva as specimen for COVID-19 molecular test
Description
We will evaluate the positive and negative agreement of saliva with nasopharyngeal swab as specimens for COVID-19 molecular test.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Persons referred for COVID-19 testing including those with COVID-19 symptoms and/or a suspected SARS-COV-2 infection or undergoing surveillance testing and
Is able to give informed consent
Is able to understand oral or written instructions, and
Is able to mentally and physically perform self-collection of saliva using the provided collection device.
Exclusion Criteria:
- Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Employees of Paradigm lab and the assisted living facilities involved in the study
Members of other vulnerable populations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenli Zhou, PhD
Organizational Affiliation
Paradigm Laboratories
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paradigm Laboratories
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
12. IPD Sharing Statement
Learn more about this trial
COVID-19 Tests With Saliva Specimens
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