Evaluation of the COVIDSeq Test in Saliva Specimens From... | NCT04561089

Studies
Evaluation of the COVIDSeq Test in Saliva Specimens From COVID-19 Asymptomatic Illumina Personnel

NCT04561089

Sponsor

Illumina, Inc.

Status

Completed

Last Update Posted

Jan 21, 2022Actual

Enrollment

763Actual

Phase

Not provided

Conditions

SARS-CoV-2

Interventions

COVIDSeq Test

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2020Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Feb 28, 2021Actual

First Submitted Date

Sep 21, 2020

First Submission Date that Met QC Criteria

Sep 22, 2020

First Posted Date

Sep 23, 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

Jan 20, 2022

Last Update Posted Date

Jan 21, 2022Actual

Name	Class
Helix OpCo, LLC	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

"This is a prospective, multi-center specimen collection study. Subjects 18 years of age or older who do not have symptoms of COVID-19 will be enrolled. Two nasal swab samples and one saliva sample will be collected from each subject. The saliva sample will be tested with the COVIDSeq Test and one nasal swab will be tested with an EUA approved COVID test. The other nasal swab sample will be stored and a subset (approximately 250 specimens) will be tested with the COVIDSeq Test. Results of all testing will be provided to the sponsor for statistical analysis.

Positive results from COVIDSeq Test using saliva and/or the comparator EUA test will be provided to subjects so participants can be referred for further evaluation (outside the study). No medical treatment, guidance on treatment decisions, nor medical care will be provided. "

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

763Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 asymptomatic population		COVID-19 asymptomatic Illumina personnel	Diagnostic Test: COVIDSeq Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVIDSeq Test	Diagnostic Test	The COVIDSeq is designed to test RNA extracted from NP swab specimens from patients symptomatic for COVID-19	COVID-19 asymptomatic population

Measure	Description	Time Frame
Positive percent agreement (PPA) and negative percent agreement (NPA) between the COVIDSeq Test and a comparator EUA test for the detection of SARS-CoV-2 RNA		1 month

Eligibility Module

Eligibility Criteria

Subject Inclusion Criteria:

An individual must meet the criteria below to be eligible.

Individual is Illumina US personnel (eg, employee, contractor, consultant) and was invited to participate in the study.
Individual is 18 years or older at the time of consent.
Individual is feeling well and, at the time of consent or specimen collection, does not have any of the following symptoms of COVID-19: cough, shortness of breath or difficulty breathing, fatigue, fever or chills, muscle or body aches, headache, sore throat, new loss of taste or smell, congestion or runny nose, nausea or vomiting, or diarrhea. [1]
Individual is willing to participate in study procedures and able to provide written informed consent in the English language.

Subject Exclusion Criteria:

An individual cannot meet the below criteria.

Individual is confirmed to have COVID-19 and continues to require home isolation in accordance with current CDC guidelines at the time of consent or specimen collection.
Individual is asymptomatic but suspected to have COVID-19 due to recent close contact (as currently defined by the CDC) with a person with COVID-19 and continues to require quarantine in accordance with current CDC guidelines at the time of consent or specimen collection. [4]
Individual had symptoms of COVID-19 less than 10 days before time of consent or less than 10 days before time of any subsequent specimen collection visit."

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

Illumina personnel

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Illumina Laboratory Services		Foster City	California	94404	United States
Illumina Hayward