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.
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
Cohort 1. Exposed to coronavirus disease
Inclusion criteria
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
Exclusion Criteria
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
Exclusion Criteria
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
Exclusion Criteria
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)
Adaptive Biotechnologies
Seattle, Washington, United States