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Evaluation of the COVIDSeq Test in Saliva Specimens From COVID-19 Asymptomatic Illumina Personnel | Clinical Trials | Clareo Health

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

Evaluation of the COVIDSeq Test in Saliva Specimens From Illumina Personnel

NCT04561089•Illumina, Inc.

View on ClinicalTrials.gov

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. "

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

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."

Locations (3)

Illumina Laboratory Services

Foster City, California, United States

Illumina Hayward

Hayward, California, United States

Illumina Laboratory Services

San Diego, California, United States

Key Dates

Start Date

February 13, 2020

Primary Completion Date

February 28, 2021

Completion Date

February 28, 2021

Last Updated

January 21, 2022

Enrollment

763

ACTUAL participants

Conditions

SARS-CoV-2

Interventions

COVIDSeq Test

DIAGNOSTIC_TEST

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Long COVIDSars-CoV-2 Infection+2 more

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RECRUITINGPHASE1

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

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SARS-CoV-2 Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age

COVID-19 - Study of the Kinetics of the Immune Response During the Intensive Care Unit Stay in Adult Patients Infected With SARS-CoV-2: Multicentric Non Interventional Study