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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-C-0103

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

COVID-19

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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Eligibility

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

- No Exclusions


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert J. Kreitman, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N248A
10 CENTER DR
BETHESDA MD 20892
(301) 648-7375
kreitmar@mail.nih.gov

Holly Eager (DiFebo), R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N240
10 Center Drive
Bethesda, Maryland 20892
(240) 858-7229
holly.eager@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT04362865

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