Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04362865 |
| Other study ID # |
200103 |
| Secondary ID |
20-C-0103 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 27, 2020 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
June 3, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background:
People who get infected with COVID-19 have an unpredictable risk to worsen and die. This
makes it hard to decide who can quarantine at home and who should be treated at a hospital.
Researchers think the risk may be related to how a person s B and T cells respond to the
virus. B and T cells are the major components of a person s immune response. B and T cells
responding to the virus with a favorable pattern may lead to recovery, and this favorable
pattern may be helpful to establish. If people in a vaccine trial get this same favorable
pattern when responding to a vaccine, this may be a useful early signal that the vaccine will
be successful.
Objective:
To examine how immune cells respond to COVID-19 infection.
Eligibility:
Adults ages 18 and older who have a confirmed or suspected COVID-19 infection or had COVID-19
in the past.
Also, healthy donors with no suspected COVID-19 infection
Design:
Participants will be screened with medical record review.
Participants will be tested with a research assay to determine who was infected with COVID-19
and who was not. This test will be used to understand research results, not to advise
patients.
Participants with active infection must be isolated, usually in a hospital.
Other participants may give blood samples at NIH or at their local doctor s office or lab.
Participants may give blood samples up to three times a week for a total of ten times, and
may also give blood samples after starting a vaccine trial.
Participants will be contacted by phone or email every 2 months for up to 2 years.
Description:
Background:
Patients infected with COVID-19 have an unpredictable risk to worsen and die, making it
difficult to decide who can quarantine at home and who should be monitored for respiratory
failure as an inpatient. This risk may be related in part to the patient s immune response
which can be characterized with respect to the B- and T-cell repertoire. Determining patterns
of immune response which correlate with clinically effective immunity may help in determining
risk.
Patients receiving a vaccine for COVID-19 are tested for antibody production, but ultimately
protection from infection and survival are the most important endpoints, which will take
time. If patients can be checked for a pre-defined favorable pattern of immune response, it
may significantly speed selection of effective candidate vaccines.
In patients with hematologic malignancies, including patients with hairy cell leukemia (HCL)
who we have extensive experience treating, we do not know if we should be steering away more
from treatments which harm B-cell immunity, like rituximab or obinutuzumab, or steering away
more from treatments which harm T-cell immunity, like purine analogs. Characterizing the
immune response in COVID-19 patients will quickly answer this question.
Objective:
To characterize immune response in patients with current or prior COVID-19 infection
Eligibility:
Age 18 years or older
Patients with known or suspected COVID-19 infection, or normal donors (i.e., those
individuals without COVID-19)
Design:
Blood samples will be collected for research to characterize immune response.
In individuals with suspected or known current or prior COVID-19, samples will be obtained up
to every three days but no more than 10 times overall during the acute phase of infection.
After recovery, samples will be collected up to ten times overall. In individuals without
COVID-19 at the time of enrollment (i.e., normal donors), samples will be collected at least
once; in the case of future COVID-19 infection, samples may be collected at the same times
during/post-infection as an individual with COVID-19 at enrollment.
Additional blood and urine samples may be collected in all subjects before and after the
receipt of COVID-19-related vaccination.
All subjects will be followed for approximately 2 years.
This protocol does not involve treatment. The accrual ceiling is set at 745 subjects.
