Covid19NCT04494893
ImmuneRACE - Immune Response Action to COVID-19 Events
An observational study of Covid19, run by Adaptive Biotechnologies at 1 site in United States.
Trial summary
ImmuneRACE is a study, which is designed to better understand the immune response to COVID-19. 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 more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- How many people
- 808 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2020to 23 Apr 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1000 individuals, between the ages of 18 - 89, who reside within the United States. Blood samples and nose or throat swabs will be collected at affiliated sites or with mobile phlebotomy. These samples will be shipped frozen or transported refrigerated or at room temperature to Adaptive Biotechnologies for processing, including, but not limited to DNA extraction and analysis. Minors, pregnant women, prisoners, mentally disabled persons, and wards-of-the-state will be excluded to prevent any risk to vulnerable populations. The selection of participants will be equitable per 45 CFR 111(a).
Who may be able to join
- Participants must satisfy the following criteria to be enrolled in the study:
- Individuals exposed to someone with a confirmed diagnosis of coronavirus disease within 2 weeks of exposure (or at the discretion of the investigator) 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:
- Individuals who have not been exposed to a person with a confirmed diagnosis of coronavirus disease within 2 weeks of exposure (or at the discretion of the investigator) 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 (at the discretion of the investigator)
- Cohort 2. Active coronavirus disease Inclusion criteria
- Participants must satisfy the following criteria to be enrolled in the study:
- Individuals with a diagnosis of coronavirus disease:
- Either by clinical diagnosis made by a medical professional, or By positive laboratory test, including but not limited to naso- or oropharyngeal swab (or at the discretion of the investigator) 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
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- The presence of any of the following will exclude a participant from enrollment:
- Individuals without a diagnosis of coronavirus disease 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 (at the discretion of the investigator)
- Cohort 3. Recovered from coronavirus disease Inclusion criteria
- Participants must satisfy the following criteria to be enrolled in the study:
- Individuals previously diagnosed with coronavirus disease and cleared from active infection by:
- Testing negative on two consecutive naso- or oropharyngeal swab tests following initial diagnosis, or Cleared by a healthcare professional or public health authority, or Resolution of symptoms related to COVID-19 (or at the discretion of the investigator) 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
- The presence of any of the following will exclude a participant from enrollment:
- Individuals without a previous diagnosis of coronavirus disease at the discretion of the investigator 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 (at the discretion of the investigator)
Trial locations and contacts
1 site in 1 country.
About this study
ImmuneRACE is a study, which is designed to better understand the immune response to COVID-19. 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. De-identified data collected from this study may accelerate the development of better diagnostics for COVID-19 and improve outcomes for many.
Read the detailed description
PURPOSE Aim 1. Compare disease-specific TCR signatures in patients vs. controls Aim 2. Identify antigens that elicit a T-cell response Aim 3. Risk Stratification based on immune signature Aim 4. Early detection
Secondary Aim:
Aim 5. Identify and/or confirm antigenic binding (BCR PairSEQ/neutralizing antibodies)
STUDY POPULATION Approximately 1000 individuals, between the ages of 18 - 89 Cohort 1. EXPOSED to someone with a confirmed diagnosis of COVID-19 Cohort 2. ACTIVE COVID-19
Individuals with a confirmed diagnosis of COVID-19:
Clinical diagnosis made by a medical professional, or Positive laboratory test Cohort 3. RECOVERED from COVID-19
Individuals with a previously confirmed diagnosed and cleared from active infection by either:
Testing negative on two consecutive swab tests, or Cleared by a healthcare professional, or Resolution of symptoms
METHODS Decentralized study (visits occur at participant's houses) Utilizing remote phlebotomy to collect (1) whole blood, (2) serum, (3) nose or throat swab Collection of relevant metadata by electronic questionnaire
Option for longitudinal collection of up to 4 additional blood draws and questionnaires
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Exposed to coronavirus disease | |
| Cohort 2 | Active coronavirus disease | |
| Cohort 3 | Recovered from coronavirus disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of disease-specific TCR signatures in patients and controls
We will run immunoSEQ on approximately 1000 patient samples with disease status unblinded. After sequencing these samples, we will quantitatively describe the compartment of the T-cell repertoire specific for the disease of interest. We will then use these data to construct a classifier that accurately distinguishes patients from controls.
Measured: Baseline
Identify the immunodominant antigens that elicit a T-cell response to COVID-19
We developed technology to query the antigen specificity of the T-cell repertoire to hundreds of peptide epitopes in a single blood sample5. This technology not only allows us to parse out immunodominant epitopes of a given infection from irrelevant epitopes, but also allows us to determine the TCR sequences of the T cells responding to these immunodominant epitopes. We will use this technology to determine which peptide epitopes derived from the SARS-CoV-2 genome commonly elicit an immunodominant T-cell response in different samples. The TCR sequence data generated from these studies will be used to boost the diagnostic classifier obtained in Aim 1. In addition, the identification of immunodominant epitopes can be disseminated to fuel studies in vaccine design and antigen specific T-cell responses relating to clinical outcome in other labs.
Measured: Baseline
Risk Stratification based on an individual's immune signature
There is a critical need for a reliable risk stratification test to enable treatment prioritization given the potentially massive number of symptomatic patients. Despite an emerging understanding of the diagnosis of COVID-19, how it spreads, and the death rate, there is no currently available way to predict who needs hospitalization beyond age associated risk and limited epidemiologically linked comorbidities.
Measured: Baseline
Determine whether an immune signature can be detected in individuals exposed to SARS-CoV-2 earlier than currently available tests
Another critical need to contain the spread of SARS-CoV-2 is to determine the false negative rate of the RNA test in asymptomatic people and offer an alternative diagnostic that is more sensitive in this cohort. For example, it is possible that early stage disease is not picked up by RNA tests because the virus may be isolated to regions such as the lower respiratory cavity that are not assessed by standard testing methods. We aim to determine whether the immune response can be used to detect the virus from a simple blood test thereby providing a more sensitive test in asymptomatic people even if the virus itself is not directly detectable in the upper respiratory region.
Measured: Baseline
Secondary outcomes (1)
Explore whether additional research assays could potential identify and/or confirm antigenic binding
As a secondary aim, Adaptive will perform explorational research with additional sequencing-based research assays to profile the adaptive immune system, such as, but not limited to TCR pairSEQ26 and B-cell receptor (BCR) pairSEQ3. These assays use a combinatorial method for pairing TCR alpha and beta chain sequences and BCR heavy and light chain sequences. The output is a large set of full length paired BCR or TCR sequences, which allows reconstruction of a functional antibody or TCR. We regularly utilize the results of our pairSEQ assays to identify and/or confirm antigenic binding. For the case of BCR pairSEQ, the resulting antibody sequences could potentially have therapeutic value for imparting passive immunity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start24 Apr 2020
- Primary completion23 Mar 2021
- Study completion23 Apr 2021
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
- 808 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494893
- Sponsor's protocol ID
- ADAP-006
- Status last verified
- Feb 2022
- First submitted
- 29 Jul 2020
- Last updated
- 16 Feb 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 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmuneRACE - Immune Response Action to COVID-19 Events
- ClinicalTrials.gov ID
- NCT04494893
- Acronym / sponsor ID
- ADAP-006
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 808 participants (actual)
- Lead sponsor
- Adaptive BiotechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 31 Jul 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.
ImmuneRACE is a study, which is designed to better understand the immune response to COVID-19. 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. De-identified data collected from this study may accelerate the development of better diagnostics for COVID-19 and improve outcomes for many.
Detailed description
PURPOSE Aim 1. Compare disease-specific TCR signatures in patients vs. controls Aim 2. Identify antigens that elicit a T-cell response Aim 3. Risk Stratification based on immune signature Aim 4. Early detection
Secondary Aim:
Aim 5. Identify and/or confirm antigenic binding (BCR PairSEQ/neutralizing antibodies)
STUDY POPULATION Approximately 1000 individuals, between the ages of 18 - 89 Cohort 1. EXPOSED to someone with a confirmed diagnosis of COVID-19 Cohort 2. ACTIVE COVID-19
Individuals with a confirmed diagnosis of COVID-19:
Clinical diagnosis made by a medical professional, or Positive laboratory test Cohort 3. RECOVERED from COVID-19
Individuals with a previously confirmed diagnosed and cleared from active infection by either:
Testing negative on two consecutive swab tests, or Cleared by a healthcare professional, or Resolution of symptoms
METHODS Decentralized study (visits occur at participant's houses) Utilizing remote phlebotomy to collect (1) whole blood, (2) serum, (3) nose or throat swab Collection of relevant metadata by electronic questionnaire
Option for longitudinal collection of up to 4 additional blood draws and questionnaires
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Exposed to coronavirus disease |
| Cohort 2 | – | –Active coronavirus disease |
| Cohort 3 | – | –Recovered from coronavirus disease |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 individuals, between the ages of 18 - 89, who reside within the United States. Blood samples and nose or throat swabs will be collected at affiliated sites or with mobile phlebotomy. These samples will be shipped frozen or transported refrigerated or at room temperature to Adaptive Biotechnologies for processing, including, but not limited to DNA extraction and analysis. Minors, pregnant women, prisoners, mentally disabled persons, and wards-of-the-state will be excluded to prevent any risk to vulnerable populations. The selection of participants will be equitable per 45 CFR 111(a).
Key inclusion criteria (2 listed)
- Individuals exposed to someone with a confirmed diagnosis of coronavirus disease within 2 weeks of exposure (or at the discretion of the investigator) 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 (14 listed)
- Individuals who have not been exposed to a person with a confirmed diagnosis of coronavirus disease within 2 weeks of exposure (or at the discretion of the investigator) 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 (at the discretion of the investigator)
- Cohort 2. Active coronavirus disease Inclusion criteria
- Either by clinical diagnosis made by a medical professional, or By positive laboratory test, including but not limited to naso- or oropharyngeal swab (or at the discretion of the investigator) 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
- Individuals without a diagnosis of coronavirus disease 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 (at the discretion of the investigator)
- Cohort 3. Recovered from coronavirus disease Inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of disease-specific TCR signatures in patients and controls
Time frame: Baseline
We will run immunoSEQ on approximately 1000 patient samples with disease status unblinded. After sequencing these samples, we will quantitatively describe the compartment of the T-cell repertoire specific for the disease of interest. We will then use these data to construct a classifier that accurately distinguishes patients from controls.
Identify the immunodominant antigens that elicit a T-cell response to COVID-19
Time frame: Baseline
We developed technology to query the antigen specificity of the T-cell repertoire to hundreds of peptide epitopes in a single blood sample5. This technology not only allows us to parse out immunodominant epitopes of a given infection from irrelevant epitopes, but also allows us to determine the TCR sequences of the T cells responding to these immunodominant epitopes. We will use this technology to determine which peptide epitopes derived from the SARS-CoV-2 genome commonly elicit an immunodominant T-cell response in different samples. The TCR sequence data generated from these studies will be used to boost the diagnostic classifier obtained in Aim 1. In addition, the identification of immunodominant epitopes can be disseminated to fuel studies in vaccine design and antigen specific T-cell responses relating to clinical outcome in other labs.
Risk Stratification based on an individual's immune signature
Time frame: Baseline
There is a critical need for a reliable risk stratification test to enable treatment prioritization given the potentially massive number of symptomatic patients. Despite an emerging understanding of the diagnosis of COVID-19, how it spreads, and the death rate, there is no currently available way to predict who needs hospitalization beyond age associated risk and limited epidemiologically linked comorbidities.
Determine whether an immune signature can be detected in individuals exposed to SARS-CoV-2 earlier than currently available tests
Time frame: Baseline
Another critical need to contain the spread of SARS-CoV-2 is to determine the false negative rate of the RNA test in asymptomatic people and offer an alternative diagnostic that is more sensitive in this cohort. For example, it is possible that early stage disease is not picked up by RNA tests because the virus may be isolated to regions such as the lower respiratory cavity that are not assessed by standard testing methods. We aim to determine whether the immune response can be used to detect the virus from a simple blood test thereby providing a more sensitive test in asymptomatic people even if the virus itself is not directly detectable in the upper respiratory region.
1 secondary outcome
Explore whether additional research assays could potential identify and/or confirm antigenic binding
Time frame: Baseline
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 16 Feb 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.
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 Covid19, 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 2 inclusion and 14 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 16 Feb 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?
Comparison of disease-specific TCR signatures in patients and controls (time frame: Baseline). The study lists 4 primary outcomes in all. 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 16 Feb 2022.