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

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ClinicalTrials.gov Identifier: NCT04362865
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease
COVID-19

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 530 subjects.

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Study Type : Observational
Estimated Enrollment : 530 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2024

Group/Cohort
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)



Primary Outcome Measures :
  1. Characterize immune response [ Time Frame: Ongoing ]
    characterize immune response in patients with active or prior COVID-19 infection


Secondary Outcome Measures :
  1. Immune response and outcome [ Time Frame: ongoing ]
    determine if there is a correlation between the pattern of immune response to COVID-19 and outcome in patients with acute or resolved infection

  2. B- and T-cell arm immune response [ Time Frame: ongoing ]
    determine if the B- or T-cell arm of the immune response is more active in responding to COVID-19 infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary clinical
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

- Immunosuppressive treatments, such as cytotoxic chemotherapy and current rituximab which would decrease normal B-cells. Subjects on steroid therapy would be eligible.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362865


Contacts
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Contact: Holly Eager, R.N. (240) 858-7229 holly.eager@nih.gov

Locations
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United States, District of Columbia
Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: James Boscoe    301-821-1530    bosjames.h.boscoe@medstar.net   
United States, Maryland
Medstar Franklin Square Medical Center Recruiting
Baltimore, Maryland, United States, 21237
Contact: James Boscoe    301-821-1530    bosjames.h.boscoe@medstar.net   
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Medstar Montgomery Medical Center Recruiting
Olney, Maryland, United States, 20832
Contact: James Boscoe    301-821-1530    bosjames.h.boscoe@medstar.net   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Robert J Kreitman, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04362865    
Other Study ID Numbers: 200103
20-C-0103
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 18, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Pandemic
Coronavirus
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases