Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection

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.

• 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

• No Exclusions