Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans

NCT04565067 | Active Not Recruiting

• 2 other identifiers: 10000140000140-AG
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The higher death rate from COVID-19 in the older population is associated with low CD8 T cell counts in the blood. Researchers want to learn the status of CD8 T cells specific to SARS-CoV-2 and their changes with aging and in COVID-19. This may help to identify why COVID-19 is particularly lethal in the elderly and help to create an effective vaccine against SARS-CoV-2 in the elderly. Objective: To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantity and quality in people who have recovered from COVID-19. Eligibility: Maryland residents age 18 and older who have tested positive for and recovered from COVID-19. Design: Participants will be screened by phone. They must be able to provide a copy of their positive COVID-19 test result. Participants will visit the NIA/Clinical Research Unit. The visit will take about 1 hour. Laboratory tests showing a positive COVID-19 result will be verified. Participants vital signs will be checked. This will include blood pressure, temperature, pulse, and respiration. Height and weight will be measured. Participants will have a medical history and medicine review. They will complete a COVID-19 questionnaire. Participants will have blood drawn. They will give a urine sample. Participants will give a saliva sample. They will rinse their mouth with water. After about 3 minutes, they will let saliva pool in the base of their mouth and then spit into a sterile container. Participants may be asked if they would be willing to return for optional visits at about 4 months and 1 year later. They will repeat the same laboratory sampling performed at the first visit. ...

Conditions

COVID-19

Keywords

CD8 T Cell; COVID-19; Immune Response; Epitope; Aging; Natural History

Outcome Measures

Primary Outcomes (1)

• Determine CD8 T cells that are responsive to SARS-CoV-2.

  We are investigating the presence or absence of various SARS-CoV-2 specific CD8 T cells in healthy adults and in COVID-19 recovered patients to understand the composition of CD8 T cell immunity in COVID-19 pathogenesis.

  4 month and 1 year data

Secondary Outcomes (1)

• Determine CD8 T cells that are responsive to SARS-CoV-2.

  Ongoing

Study Arms (1)

1

COVID-19 recovered adult patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 recovered adult patients: sample size =100, both genders, 18 years of age and older, all races, and residents of the state of Maryland.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Ability of subject to understand the study and stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 18 years or older.
• Able to speak and read English.
• Willingness and ability to come to the NIA Clinical Research Unit at MedStar Harbor Hospital in Baltimore for study procedures.
• Proof of positive SARS-CoV-2 testing exhibiting no current clinical symptoms.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Unable to verify identification of volunteer by state issued ID card, driver's license, or military ID. Participants earning greater than $600.00/year are issued a 1099 form, therefore, positive identification is required.
• Unable to provide informed consent
• Current use of steroids, immunosuppressive medications, radiation therapy, or chemotherapy medications.
• Pregnancy.
• Received immunization therapy for COVID-19 or have received a COVID-19 vaccination prior to Visit 1.
• In addition, eligible participants may not be immediately able to participate in the study but might be eligible at a later date. These include:
• Symptoms of a viral infection on visit 1 (defer until resolved).
• Medication: Volunteers taking the following medications would be deferred for 2 weeks after course has been completed and volunteer is feeling well: Antibiotics, antifungals, antimalarials, antvirals.
• Temporary steroids (tapers): Deferred for 72 hours after symptoms are resolved and prescription is completed if taken orally, intravenously, or intramuscular. No deferral if taken intranasal, inhaled, or for joint injection.
• Infection or Fever: Deferred until 2 weeks after antibiotics are completed and /or volunteer is feeling well.
• We wish to only select recovered confirmed COVID-19 patients. Therefore, those who may have a household member (co-habitant) who is newly diagnosed with COVID-19 or who has symptoms will be deferred for 14 days.
• Treatment with another investigational drug or other intervention within 14 days of visit 1 per the discretion of the Principal Investigator.

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Yao Q, Doyle ME, Liu QR, Appleton A, O'Connell JF, Weng NP, Egan JM. Long-Term Dysfunction of Taste Papillae in SARS-CoV-2. NEJM Evid. 2023 Sep;2(9):10.1056/evidoa2300046. doi: 10.1056/evidoa2300046. Epub 2023 Jul 20.

  PMID: 38145006 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Nan-Ping P Weng, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 25, 2020
• Study Start: September 22, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-11-17

Locations

US (1)