COVID-19 Tests With Saliva Specimens | NCT04567953

Studies
COVID-19 Tests With Saliva Specimens

NCT04567953

Sponsor

Paradigm Laboratories LLC

Status

Unknown status

Last Update Posted

Sep 29, 2020Actual

Enrollment

2,000Estimated

Phase

Not Applicable

Conditions

Covid19

Interventions

Saliva collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2020Actual

Primary Completion Date

Jan 30, 2021Estimated

Completion Date

Jun 27, 2021Estimated

First Submitted Date

Sep 25, 2020

First Submission Date that Met QC Criteria

Sep 25, 2020

First Posted Date

Sep 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2020

Last Update Posted Date

Sep 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Saliva and NP paired specimen collection	Experimental		Other: Saliva collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saliva collection	Other	Use Spectrum Solutions SDNA1000 or Orasure collection kit or dry tube to collect 1-3 ml of saliva	Saliva and NP paired specimen collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wenli Zhou, PhD	Paradigm Laboratories	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Paradigm Laboratories		Tucson	Arizona	85712	United States

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided