Clinical trial NCT04494893: ImmuneRACE - Immune Response Action to COVID-19 Events
Official title: ImmuneRACE - Immune Response Action to COVID-19 Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Adaptive Biotechnologies
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2020-07-31
Enrollment: 808
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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. 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

Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of disease-specific TCR signatures in patients and controls
timeFrame: Baseline
measure: Identify the immunodominant antigens that elicit a T-cell response to COVID-19
timeFrame: Baseline
measure: Risk Stratification based on an individual's immune signature
timeFrame: Baseline
measure: Determine whether an immune signature can be detected in individuals exposed to SARS-CoV-2 earlier than currently available tests
timeFrame: Baseline
Secondary outcomes:
measure: Explore whether additional research assays could potential identify and/or confirm antigenic binding
timeFrame: Baseline
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Adaptive Biotechnologies
state: Washington
Study officials:
References: