CClinicalTrials.gg
Status unknownNCT04567953Updated Sep 29, 2020

COVID-19 Tests With Saliva Specimens

An interventional study of Saliva collection in Covid19, sponsored by Paradigm Laboratories LLC. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by Paradigm Laboratories LLC · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Covid19

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03

In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Paradigm Laboratories LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Experimental
    Saliva and NP paired specimen collection

    Other: Saliva collection

Interventions

  • OtherSaliva collection

    Use Spectrum Solutions SDNA1000 or Orasure collection kit or dry tube to collect 1-3 ml of saliva

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 hour

07

Study locations

1 site
  • Paradigm Laboratories
    Tucson, Arizona 85712, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04567953
Lead sponsor
Paradigm Laboratories LLC
Responsible party
Sponsor
First posted
Sep 29, 2020
Start date
Jul 28, 2020
Primary completion
Jan 30, 2021 (estimated)
Completion
Jun 27, 2021 (estimated)
Last update
Sep 29, 2020

Study contacts

Wenli Zhou, PhD
principal investigator · Paradigm Laboratories

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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