Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection
- - INCLUSION CRITERIA: - Individuals who meet one of the following groups: - Patients with a confirmed or suspected diagnosis of COVID-19 infection, current or resolved; or, - Normal donors. Note: For the purpose of this study, normal donors are those without a known current, past, or suspected COVID-19 infection; individuals may have other medical comorbidities or conditions. - At least 18 years of age - Ability of patient or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document EXCLUSION CRITERIA: Individuals with COVID-19 - Desire of the patient or normal donor not to submit samples, or medical contraindication to sending samples. EXCLUSION CRITERIA: Normal Donors - Immunosuppressive treatments, such as cytotoxic chemotherapy and current rituximab which would decrease normal B-cells. Subjects on steroid therapy would be eligible.
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
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.
To characterize immune response in patients with current or prior COVID-19 infection
Age 18 years or older
Patients with known or suspected COVID-19 infection, or normal donors (i.e., those
individuals without COVID-19)
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 430 subjects.
Trial Phase Phase NA
Trial Type Not provided by clinicaltrials.gov
National Cancer Institute
Robert J. Kreitman
- Primary ID 200103
- Secondary IDs NCI-2020-03170, 20-C-0103
- Clinicaltrials.gov ID NCT04362865