CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 679 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04362865
NCT04362865N/ACompleted

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

National Cancer Institute (NCI)·observational·Posted Apr 27, 2020·Updated Mar 7, 2025

In Brief

An observational study for COVID-19. Completed, enrolled 679 participants across 4 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 27, 2020
Enrollment StartApr 27, 2020
Primary CompletionFeb 10, 2025
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 6.2 years ago