Coronavirus Disease (COVID-19)NCT04583982
ImmuneSense™ COVID-19 Study
An observational study of Coronavirus Disease (COVID-19) and SARS-CoV-2 Infection, run by Adaptive Biotechnologies at 1 site in United States.
Trial summary
Coronavirus disease is of an urgent global priority. The purpose of ImmuneSense™ COVID-19 study is to evaluate the clinical performance and to provide data for clinical validation for the T-Detect™ SARS-CoV-2 (previously referred to as immunoSEQ Dx SARS-CoV-2) Assay in support of Adaptive's Emergency Use Authorization… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Coronavirus Disease (COVID-19), SARS-CoV-2 Infection
- What is being tested?
- T-Detect™ SARS-CoV-2 Assay
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2020to 4 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants include male and female participants, of any race and ethnicity, ages 18-89.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Adaptive Biotechnologies Clinical Investigational Site
Secaucus, New Jersey, 07094
About this study
Coronavirus disease is of an urgent global priority. The purpose of ImmuneSense™ COVID-19 study is to evaluate the clinical performance and to provide data for clinical validation for the T-Detect™ SARS-CoV-2 (previously referred to as immunoSEQ Dx SARS-CoV-2) Assay in support of Adaptive's Emergency Use Authorization (EUA) request for T-Detect™ SARS-CoV-2 and secondary aims. This assay is intended to detect immune response to the virus that causes coronavirus disease (COVID-19), SARS-CoV-2. This is critically important because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease that current tests cannot.
Read the 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.
- Being tested
- T-Detect™ SARS-CoV-2 Assay
- Keywords
- COVID-19, SARS-CoV-2, Coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Detect™ SARS-CoV-2 AssayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Study Arm SARS-CoV-2 negative and positive samples | Not described Receives: Other: T-Detect™ SARS-CoV-2 Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate clinical agreement of T-Detect™ SARS-CoV-2 Assay
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.
Measured: Initial Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start9 Oct 2020
- Primary completion4 Dec 2020
- Study completion4 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease (COVID-19)Studies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Namita Singh, MD, Study director, Medical Director, Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583982
- Sponsor's protocol ID
- PRO-00781
- Status last verified
- Apr 2022
- First submitted
- 7 Oct 2020
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmuneSense™ COVID-19 Study
- ClinicalTrials.gov ID
- NCT04583982
- Acronym / sponsor ID
- PRO-00781
- Keywords
- COVID-19, SARS-CoV-2, Coronavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Adaptive BiotechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 12 Oct 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.
Coronavirus disease is of an urgent global priority. The purpose of ImmuneSense™ COVID-19 study is to evaluate the clinical performance and to provide data for clinical validation for the T-Detect™ SARS-CoV-2 (previously referred to as immunoSEQ Dx SARS-CoV-2) Assay in support of Adaptive's Emergency Use Authorization (EUA) request for T-Detect™ SARS-CoV-2 and secondary aims. This assay is intended to detect immune response to the virus that causes coronavirus disease (COVID-19), SARS-CoV-2. This is critically important because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease that current tests cannot.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Study Arm SARS-CoV-2 negative and positive samples | – | Other: T-Detect™ SARS-CoV-2 Assay |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants include male and female participants, of any race and ethnicity, ages 18-89.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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™ SARS-CoV-2 AssayT-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. | Other | Prospective Study Arm SARS-CoV-2 negative and positive samples |
Primary outcome
Demonstrate clinical agreement of T-Detect™ SARS-CoV-2 Assay
Time frame: Initial Visit
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.
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 15 Apr 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.
Namita Singh, MD study director
Medical Director, Clinical Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease (COVID-19) and SARS-CoV-2 Infection, run by Adaptive Biotechnologies at 1 site 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 4 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 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Demonstrate clinical agreement of T-Detect™ SARS-CoV-2 Assay (time frame: Initial Visit). 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 15 Apr 2022.