COVID-19NCT04362865
Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection
An observational study of COVID-19, run by National Cancer Institute (NCI) at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 679 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Apr 2020to 10 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary clinical
Who may be able to join
- 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
Who cannot join
- Desire of the patient or normal donor not to submit samples, or medical contraindication to sending samples.
- No Exclusions
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medstar Franklin Square Medical Center
Baltimore, Maryland, 21237
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Medstar Montgomery Medical Center
Olney, Maryland, 20832
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read more
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.
Read the 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.
- Conditions
- COVID-19
- Keywords
- Pandemic, Coronavirus, SARS-CoV-2, Natural History
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 infection | Patients with confirmed or suspected COVID-19 infections | |
| No COVID-19 infection | Patients without confirmed or suspected COVID-19 infections (i.e., normal donors) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize immune response
characterize immune response in patients with active or prior COVID-19 infection
Measured: Ongoing
Secondary outcomes (2)
Immune response and outcome
determine if there is a correlation between the pattern of immune response to COVID-19 and outcome in patients with acute or resolved infection
Measured: ongoing
B- and T-cell arm immune response
determine if the B- or T-cell arm of the immune response is more active in responding to COVID-19 infection
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start27 Apr 2020
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 679 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Kreitman, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362865
- Sponsor's protocol ID
- 200103
- Other IDs
- 20-C-0103
- Status last verified
- Mar 2025
- First submitted
- 24 Apr 2020
- Last updated
- 7 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Publications
Kreitman RJ, James L, Feurtado J, Eager H, Sierra Ortiz O, Gould M, Shpilman I, Zhou H, Burbelo PD, Cohen JI, Wang HW, Yuan CM, Arons E. COVID-19 vaccination in patients with classic and variant hairy cell leukemia. Blood Neoplasia. 2024 Aug 28;1(4):100035. doi: 10.1016/j.bneo.2024.100035. eCollection 2024 Dec.
PubMed 40552139Arons E, Henry K, Haas C, Gould M, Tsintolas J, Mauter J, Zhou H, Burbelo PD, Cohen JI, Kreitman RJ. Characterization of B-cell receptor clonality and immunoglobulin gene usage at multiple time points during active SARS-CoV-2 infection. J Med Virol. 2023 Oct;95(10):e29179. doi: 10.1002/jmv.29179.
PubMed 37877800Kreitman RJ, Yu T, James L, Feurtado J, Eager H, Ortiz OS, Gould M, Mauter J, Zhou H, Burbelo PD, Cohen JI, Wang HW, Yuan CM, Arons E. COVID-19 in patients with classic and variant hairy cell leukemia. Blood Adv. 2023 Dec 12;7(23):7161-7168. doi: 10.1182/bloodadvances.2023011147.
PubMed 37729613
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04362865
- Acronym / sponsor ID
- 200103
- Conditions
- COVID-19
- Keywords
- Pandemic, Coronavirus, SARS-CoV-2, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 679 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 infection | – | –Patients with confirmed or suspected COVID-19 infections |
| No COVID-19 infection | – | –Patients without confirmed or suspected COVID-19 infections (i.e., normal donors) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary clinical
Key inclusion criteria (5 listed)
- Individuals who meet one of the following groups:
- 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
Key exclusion criteria (2 listed)
- Desire of the patient or normal donor not to submit samples, or medical contraindication to sending samples.
- No Exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize immune response
Time frame: Ongoing
characterize immune response in patients with active or prior COVID-19 infection
2 secondary outcomes
Immune response and outcome
Time frame: ongoing
B- and T-cell arm immune response
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Derived from this study: PubMed 40552139Kreitman RJ, James L, Feurtado J, Eager H, Sierra Ortiz O, Gould M, Shpilman I, Zhou H, Burbelo PD, Cohen JI, Wang HW, Yuan CM, Arons E. COVID-19 vaccination in patients with classic and variant hairy cell leukemia. Blood Neoplasia. 2024 Aug 28;1(4):100035. doi: 10.1016/j.bneo.2024.100035. eCollection 2024 Dec.
- Derived from this study: PubMed 37877800Arons E, Henry K, Haas C, Gould M, Tsintolas J, Mauter J, Zhou H, Burbelo PD, Cohen JI, Kreitman RJ. Characterization of B-cell receptor clonality and immunoglobulin gene usage at multiple time points during active SARS-CoV-2 infection. J Med Virol. 2023 Oct;95(10):e29179. doi: 10.1002/jmv.29179.
- Derived from this study: PubMed 37729613Kreitman RJ, Yu T, James L, Feurtado J, Eager H, Ortiz OS, Gould M, Mauter J, Zhou H, Burbelo PD, Cohen JI, Wang HW, Yuan CM, Arons E. COVID-19 in patients with classic and variant hairy cell leukemia. Blood Adv. 2023 Dec 12;7(23):7161-7168. doi: 10.1182/bloodadvances.2023011147.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Kreitman, M.D. principal investigator
National Cancer Institute (NCI)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by National Cancer Institute (NCI) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize immune response (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362865, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.