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

NCT04362865 | Completed

• 2 other identifiers: 20010320-C-0103
• Study Type: observational
• Target: 679
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19

Keywords

Pandemic; Coronavirus; SARS-CoV-2; Natural History

Outcome Measures

Primary Outcomes (1)

• Characterize immune response

  characterize immune response in patients with active or prior COVID-19 infection

  Ongoing

Secondary Outcomes (2)

• Immune response and outcome

  ongoing

• B- and T-cell arm immune response

  ongoing

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary clinical

You may qualify if:

• 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

You may not qualify if:

• \- Desire of the patient or normal donor not to submit samples, or medical contraindication to sending samples.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Medstar Franklin Square Medical Center

Baltimore, Maryland, 21237, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Medstar Montgomery Medical Center

Olney, Maryland, 20832, United States

Location

Related Publications (3)

• 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.

  PMID: 40552139 DERIVED

• Arons 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.

  PMID: 37877800 DERIVED

• Kreitman 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.

  PMID: 37729613 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert J Kreitman, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 27, 2020
• Study Start: April 27, 2020
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (4)