NCT04362865

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

Completed Last updated 7 March 2025

What this trial tests

trial in COVID-19 in 679 participants. Completed in 10 February 2025.

Timeline

27 April 2020

Primary endpoint
10 February 2025

10 February 2025

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	679
Start date	27 April 2020
Primary completion	10 February 2025
Estimated completion	10 February 2025
Sites	4 locations across United States

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Deciphering the TCR Repertoire to Solve the COVID-19 Mystery.
   Gutierrez L, Beckford J, Alachkar H. · · 2020 · cited 51× · PMID 32576386 · DOI 10.1016/j.tips.2020.06.001
2. Thymic Function and T-Cell Receptor Repertoire Diversity: Implications for Patient Response to Checkpoint Blockade Immunotherapy.
   Cardinale A, De Luca CD, Locatelli F, Velardi E. · · 2021 · cited 27× · PMID 34899700 · DOI 10.3389/fimmu.2021.752042
3. COVID-19 in patients with classic and variant hairy cell leukemia.
   Kreitman RJ, Yu T, James L, Feurtado J, et al · · 2023 · cited 3× · PMID 37729613 · DOI 10.1182/bloodadvances.2023011147
4. Biological and Exploitable Crossroads for the Immune Response in Cancer and COVID-19.
   Vitali L, Merlini A, Galvagno F, Proment A, et al · · 2022 · cited 2× · PMID 36289890 · DOI 10.3390/biomedicines10102628
5. COVID-19 vaccination in patients with classic and variant hairy cell leukemia.
   Kreitman RJ, James L, Feurtado J, Eager H, et al · · 2024 · PMID 40552139 · DOI 10.1016/j.bneo.2024.100035
6. Characterization of B-cell receptor clonality and immunoglobulin gene usage at multiple time points during active SARS-CoV-2 infection.
   Arons E, Henry K, Haas C, Gould M, et al · · 2023 · PMID 37877800 · DOI 10.1002/jmv.29179