ImmuneRACE - Immune Response Action to COVID-19 Events

  • STATUS
    Recruiting
  • participants needed
    1000
  • sponsor
    Adaptive Biotechnologies
Updated on 19 February 2024
oropharyngeal
coronavirus infection

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.

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

Details
Condition COVID19
Age 18years - 89years
Clinical Study IdentifierNCT04494893
SponsorAdaptive Biotechnologies
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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