Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population

NCT ID: NCT04561102

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 644 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-11
• Study Completion Date: 2021-02-28

Brief Summary

"This is a prospective, single-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.

Results from the comparator EUA test will be provided to the collection site investigator or designated collection site study staff. No medical treatment, guidance on treatment decisions, nor medical care will be provided. "

Conditions

SARS-CoV-2

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19 asymptomatic population

COVID-19 asymptomatic Rollins College community

Diagnostic test for detection of SARS-CoV-2

Intervention Type: DIAGNOSTIC_TEST

The COVIDSeq is designed to test RNA extracted from NP swab specimens from patients symptomatic for COVID-19

Interventions

Diagnostic test for detection of SARS-CoV-2

The COVIDSeq is designed to test RNA extracted from NP swab specimens from patients symptomatic for COVID-19

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

COVIDSeq Test

Eligibility Criteria

Inclusion Criteria

An individual must meet the criteria below to be eligible.

• Individual is attending or invited to visit a participating collection site.
• Individual is 18 years or older at the time of consent.
• Individual is feeling well at the time of consent or specimen collection and does not have any of the following symptoms of COVID-19 per the current CDC guidance such as 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.
• 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 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. [5]
• Individual had symptoms of COVID-19 less than 10 days before time of consent or specimen collection."

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helix OpCo, LLC

UNKNOWN

Sponsor Role: collaborator

Illumina, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rollins College Alfonds Sports Center

Winter Park, Florida, United States

Countries

United States

Other Identifiers

COVD-B07-002

Identifier Type: -

Identifier Source: org_study_id