COVID-19 Tests With Saliva Specimens

NCT ID: NCT04567953

Last Updated: 2020-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-28

Study Completion Date

2021-06-27

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Saliva and NP paired specimen collection

Group Type EXPERIMENTAL

Saliva collection

Intervention Type OTHER

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

Interventions

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Saliva collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Paradigm Laboratories LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wenli Zhou, PhD

Role: PRINCIPAL_INVESTIGATOR

Paradigm Laboratories

Locations

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Paradigm Laboratories

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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PLRD202001

Identifier Type: -

Identifier Source: org_study_id

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