Trials / Completed
CompletedNCT04494893
ImmuneRACE - Immune Response Action to COVID-19 Events
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 808 (actual)
- Sponsor
- Adaptive Biotechnologies · Industry
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Accepted
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
Conditions
Timeline
- Start date
- 2020-04-24
- Primary completion
- 2021-03-23
- Completion
- 2021-04-23
- First posted
- 2020-07-31
- Last updated
- 2022-02-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04494893. Inclusion in this directory is not an endorsement.