Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT04494893
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2020-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ImmuneRACE - Immune Response Action to COVID-19 Events
Sponsor:
Adaptive Biotechnologies
Organization:
Study Overview
Official Title:
ImmuneRACE - Immune Response Action to COVID-19 Events
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: