ImmuneRACE - Immune Response Action to COVID-19 Events
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|ClinicalTrials.gov Identifier: NCT04494893|
Recruitment Status : Recruiting
First Posted : July 31, 2020
Last Update Posted : July 31, 2020
|Condition or disease|
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
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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||ImmuneRACE - Immune Response Action to COVID-19 Events|
|Actual Study Start Date :||April 24, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||January 31, 2021|
Exposed to coronavirus disease
Active coronavirus disease
Recovered from coronavirus disease
- 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.
- Explore whether additional research assays could potential identify and/or confirm antigenic binding [ Time Frame: Baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04494893
|Contact: Emily A Svejnoha, BSemail@example.com|
|Contact: Jen N Dines, MDfirstname.lastname@example.org|
|United States, Washington|
|Seattle, Washington, United States, 98102|
|Contact: Emily Svejnoha, BS 907-947-6996 email@example.com|