Covid19NCT05054088
ImmuneSense COVID-19 Variant Study
An observational study of Covid19, run by Adaptive Biotechnologies at 15 sites in United States.
Trial summary
This study will assess the clinical performance of the T-Detect™ COVID test to identify an immune response to SARS-CoV-2 infection in the setting of multiple circulating variants of the SARS-CoV-2 virus. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- T-Detect COVID test
- Type of treatment
- Medical device
- How many people
- 203 participants
- Where
- 15 sitesUnited States
- Study dates
- 12 Oct 2021to 28 Jul 2022
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prospective ascertainment of a target of 50 whole blood samples (1 sample per individual), and a maximum number of 250 whole blood samples, from individuals between the ages of 18-89 who reside within the United States who have tested positive for SARS-CoV-2 infection via RT-PCR test. Pregnant women, prisoners, mentally disabled persons, and wards-of-the-state will be excluded to prevent any risk to these vulnerable populations.
Who may be able to join
- Participants must satisfy the following criteria to be enrolled in the study:
- Individuals who have tested positive for SARS-CoV-2 via EUA RT-PCR testing. ii. Male and female participants of any race and ethnicity between 18 to 89 years of age (inclusive) at the time of enrollment in the study. iii. Must be able to communicate with the investigator, understand, and comply with the requirements of the study. iv. Must be able to provide estimated date of symptom onset. v. Must be available for specimen collection greater than 14 days (i.e., 15 days inclusive onward) and less than 107 days (i.e., 106 days inclusive or less) after first exhibiting symptoms of confirmed SARS-CoV-2 infection.
Who cannot join
- The presence of any of the following will exclude a participant from enrollment:
- Individuals who did not test positive for SARS-CoV-2 on EUA RT-PCR.
- Protected populations including 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.
- Exposure to a SARS-CoV-2 investigational drug (new chemical entity) within 60 days prior to enrollment at the discretion of the Sponsor.
- Receipt of immunosuppressive medications, such as, but not limited to, recent moderate- or high-dose systemic steroids or immunomodulators within 1 month prior to enrollment at the discretion of the Sponsor.
- Treatment with immunosuppressants/ immunomodulators that do not impact T cells or B cells may be allowed at the discretion of the Sponsor.
- Steroid formulations including low-dose oral steroids (≤ 10 mg prednisone equivalents per day), inhaled steroids, or topical steroids are not considered exclusionary. Doses >10 and <20 mg prednisone equivalents per day, must receive Sponsor approval.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Decentralized Trial Model- Denver
Denver, Colorado, 80014
Decentralized Trial Model- Fullerton
Fullerton, California, 90621
Decentralized Trial Model- California
Los Angeles, California, 90034
Decentralized Trial Model- Florida
Miami, Florida, 33101
Decentralized Trial Model- Modesto
Modesto, California, 95313
Decentralized Clinical Trial Model- New York City
New York, New York, 10001
Decentralized Trial Model- Phoenix
Phoenix, Arizona, 85001
Decentralized Trial Model- Portland
Portland, Oregon, 97035
Decentralized Trial Model- Sacramento
Sacramento, California, 94203
Decentralized Trial Model- Utah
Salt Lake City, Utah, 84044
Decentralized Trial Model- California
San Diego, California, 22400
Decentralized Trial Model- San Francisco
San Francisco, California, 94016
Decentralized Trial Model- Seattle
Seattle, Washington, 98109
Decentralized Trial Model- Vancouver, WA
Vancouver, Washington, 98607
Decentralized Trial Model - Washington D.C.
Washington D.C., District of Columbia, 20001
About this study
Official title: ImmuneSense™ COVID-19 Variant Study
This study will assess the clinical performance of the T-Detect™ COVID test to identify an immune response to SARS-CoV-2 infection in the setting of multiple circulating variants of the SARS-CoV-2 virus. Performance may vary depending on the variants circulating at the time of testing, including newly emerging strains of SARS-CoV-2 and their prevalence, which changes over time.
- Conditions
- Covid19
- Being tested
- T-Detect COVID test
- Keywords
- Variant
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Detect COVID testDevice
- The T-DetectTM COVID test is an EUA granted investigational device that is indicated to assess a T-cell immune response to SARS-CoV-2 via the testing of blood samples from patients with signs and symptoms of suspected COVID-19.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Subjects who have tested positive for SARS-CoV-2 by EUA RT-PCR testing with symptoms compatible with SARS-CoV-2 infection. Receives: Device: T-Detect COVID test | |
| Cohort 2 | Subjects who have tested positive for SARS-CoV-2 by EUA RT-PCR testing with symptoms compatible with SARS-CoV-2 infection. Receives: Device: T-Detect COVID test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective: Positive Percent Agreement
To determine the positive percent agreement (PPA) of the T-Detect™ COVID test with SARS-CoV-2 RT-PCR testing in populations having multiple circulating SARS-CoV-2 variant strains. The primary endpoint is the positive percent agreement (PPA) of the T-Detect™ COVID test with SARS-CoV-2 RT-PCR testing.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start12 Oct 2021
- Primary completion20 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darcy Gill, PhD, Principal investigator, Adaptive Biotechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054088
- Sponsor's protocol ID
- PRO-00974
- Status last verified
- Dec 2022
- First submitted
- 20 Sep 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmuneSense™ COVID-19 Variant Study
- ClinicalTrials.gov ID
- NCT05054088
- Acronym / sponsor ID
- PRO-00974
- Conditions
- Covid19
- Keywords
- Variant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Adaptive BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 23 Sep 2021 (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 study will assess the clinical performance of the T-Detect™ COVID test to identify an immune response to SARS-CoV-2 infection in the setting of multiple circulating variants of the SARS-CoV-2 virus. Performance may vary depending on the variants circulating at the time of testing, including newly emerging strains of SARS-CoV-2 and their prevalence, which changes over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: T-Detect COVID testSubjects who have tested positive for SARS-CoV-2 by EUA RT-PCR testing with symptoms compatible with SARS-CoV-2 infection. |
| Cohort 2 | – | Device: T-Detect COVID testSubjects who have tested positive for SARS-CoV-2 by EUA RT-PCR testing with symptoms compatible with SARS-CoV-2 infection. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective ascertainment of a target of 50 whole blood samples (1 sample per individual), and a maximum number of 250 whole blood samples, from individuals between the ages of 18-89 who reside within the United States who have tested positive for SARS-CoV-2 infection via RT-PCR test. Pregnant women, prisoners, mentally disabled persons, and wards-of-the-state will be excluded to prevent any risk to these vulnerable populations.
Key inclusion criteria (2 listed)
- Individuals who have tested positive for SARS-CoV-2 via EUA RT-PCR testing. ii. Male and female participants of any race and ethnicity between 18 to 89 years of age (inclusive) at the time of enrollment in the study. iii. Must be able to communicate with the investigator, understand, and comply with the requirements of the study. iv. Must be able to provide estimated date of symptom onset. v. Must be available for specimen collection greater than 14 days (i.e., 15 days inclusive onward) and less than 107 days (i.e., 106 days inclusive or less) after first exhibiting symptoms of confirmed SARS-CoV-2 infection.
Key exclusion criteria (8 listed)
- Individuals who did not test positive for SARS-CoV-2 on EUA RT-PCR.
- Protected populations including 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.
- Exposure to a SARS-CoV-2 investigational drug (new chemical entity) within 60 days prior to enrollment at the discretion of the Sponsor.
- Receipt of immunosuppressive medications, such as, but not limited to, recent moderate- or high-dose systemic steroids or immunomodulators within 1 month prior to enrollment at the discretion of the Sponsor.
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 |
|---|---|---|
| T-Detect COVID test• The T-DetectTM COVID test is an EUA granted investigational device that is indicated to assess a T-cell immune response to SARS-CoV-2 via the testing of blood samples from patients with signs and symptoms of suspected COVID-19. | Device | Cohort 1, Cohort 2 |
Primary outcome
Primary Objective: Positive Percent Agreement
Time frame: Baseline
To determine the positive percent agreement (PPA) of the T-Detect™ COVID test with SARS-CoV-2 RT-PCR testing in populations having multiple circulating SARS-CoV-2 variant strains. The primary endpoint is the positive percent agreement (PPA) of the T-Detect™ COVID test with SARS-CoV-2 RT-PCR testing.
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 7 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Darcy Gill, PhD principal investigator
Adaptive Biotechnologies
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Adaptive Biotechnologies at 15 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?
The sponsor lists 2 inclusion and 8 exclusion criteria. 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Primary Objective: Positive Percent Agreement (time frame: Baseline). 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 7 Dec 2022.