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.
Additional locations may be listed on ClinicalTrials.gov for NCT04362865.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNational Cancer Institute
Principal InvestigatorRobert J. Kreitman
