- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04583982
ImmuneSense™ COVID-19 Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Comprehensive diagnostic testing has an important role to play in the control and containment of the current pandemic. Adaptive Biotechnologies Corporation (Adaptive) has developed an immunosequencing technology, called immunoSEQ®, which utilizes polymerase chain reaction (PCR) and next-generation sequencing (NGS) to identify and quantify rearranged T-cell receptor (TCR) gene sequences from peripheral blood, collectively referred to as the T-cell repertoire. The T-cell repertoire can be further analyzed using indication-specific algorithms that are based on disease-associated TCR sequences.
Adaptive has developed a clinical test called T-Detect™ SARS-CoV-2, which is intended to identify a T-cell response to the SARS-CoV-2 virus, indicating recent or prior infection. In this investigational study, Adaptive plans to clinically validate samples acquired from patients with COVID-19 and present results for an eventual EUA-submission for the T-Detect™ SARS-CoV-2 Assay. T-Detect™ SARS-CoV-2 is a single-site assay performed at Adaptive Biotechnologies Corporation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Jersey
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Secaucus, New Jersey, United States, 07094
- Adaptive Biotechnologies Clinical Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria
Participants must satisfy the following criteria to be enrolled in the study:
- Currently symptomatic individuals who are being tested for SARS-CoV-2 infection by nasopharyngeal swab
- Male and female participants of any race and ethnicity between 18 to 89 years of age (inclusive) at the time of enrolling in the study
- Must be able to communicate with the investigator, understand, and comply with the requirements of the study
Exclusion criteria
The presence of any of the following will exclude a participant from enrollment:
- Asymptomatic individuals who are being tested for SARS-CoV-2 infection
- Prior confirmed diagnosis of COVID-19
- Any person who cohabitated with another individual with known COVID-19
- Protected populations including minors, pregnant women, prisoners, mentally disabled persons, and wards-of-the state
- Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
- Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw
- Participation in a COVID-19/SARS-CoV-2 study or received a COVID-19 vaccine, antibody, or other COVID-19 therapeutic Investigational drug or compound that will impact results of the study at the discretion of the investigator, such as but not limited to a COVID-19 antibody, therapeutic, or other medication that will impact the person's immune system
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Prospective Study Arm SARS-CoV-2 negative and positive samples
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T-Detect™ SARS-CoV-2 Assay is an investigational device that is indicated to assess T-cell immune response to SARS-CoV-2 via the testing of blood samples from patients with signs and symptoms of suspected COVID-19.
These results will not be shared with the participant.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demonstrate clinical agreement of T-Detect™ SARS-CoV-2 Assay
Time Frame: Initial Visit
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To demonstrate the clinical agreement of the T-Detect™ SARS-CoV-2 Assay in participants with a positive and negative result from an EUA approved RT-PCR assay.
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Initial Visit
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO-00781
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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