Clinical trial NCT04362865: Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection
Official title: Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Pandemic
Coronavirus
SARS-CoV-2
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-04-27
Enrollment: 679
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary clinical

Brief 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.

Detailed 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.

Eligibility criteria: * 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

Primary outcomes:
measure: Characterize immune response
timeFrame: Ongoing
Secondary outcomes:
measure: Immune response and outcome
timeFrame: ongoing
measure: B- and T-cell arm immune response
timeFrame: ongoing
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Baltimore
country: United States
facility: Medstar Franklin Square Medical Center
state: Maryland
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
city: Olney
country: United States
facility: Medstar Montgomery Medical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Robert J Kreitman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: