SARS-CoV-2NCT04561089
Evaluation of the COVIDSeq Test in Saliva Specimens From COVID-19 Asymptomatic Illumina Personnel
An observational study of SARS-CoV-2, run by Illumina, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- COVIDSeq Test
- How many people
- 763 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Feb 2020to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Illumina personnel
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."
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Illumina Laboratory Services
Foster City, California, 94404
Illumina Hayward
Hayward, California, 94545
Illumina Laboratory Services
San Diego, California, 92122
About this study
Official title: Evaluation of the COVIDSeq Test in Saliva Specimens From Illumina Personnel
"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. "
- Conditions
- SARS-CoV-2
- Being tested
- COVIDSeq Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVIDSeq TestDiagnostic test
The COVIDSeq is designed to test RNA extracted from NP swab specimens from patients symptomatic for COVID-19
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 asymptomatic population | COVID-19 asymptomatic Illumina personnel Receives: Diagnostic Test: COVIDSeq Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start13 Feb 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 763 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illumina, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Helix OpCo, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561089
- Sponsor's protocol ID
- COVD-B07-001
- Status last verified
- Jan 2022
- First submitted
- 21 Sep 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the COVIDSeq Test in Saliva Specimens From Illumina Personnel
- ClinicalTrials.gov ID
- NCT04561089
- Acronym / sponsor ID
- COVD-B07-001
- Conditions
- SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 763 participants (actual)
- Lead sponsor
- Illumina, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Helix OpCo, LLC
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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. "
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 asymptomatic population | – | Diagnostic Test: COVIDSeq TestCOVID-19 asymptomatic Illumina personnel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Illumina personnel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVIDSeq TestThe COVIDSeq is designed to test RNA extracted from NP swab specimens from patients symptomatic for COVID-19 | Diagnostic test | COVID-19 asymptomatic population |
Primary outcome
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
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by Illumina, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.