COVID-19NCT04565067
Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans
An observational study of COVID-19, run by National Institute on Aging (NIA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
About this study
Official title: Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans a Clinical Observation Trial
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.
Read more
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.
...
Read the detailed description
Study Description:
This study is to identify epitopes of SARS-CoV-2 that are recognized by CD8 T cells in the blood of healthy young and old participants as well as COVID-19 recovered. We will also measure general health factors using blood, saliva and urine samples. By analyzing the frequency, differentiation, and expansion of these SARS-CoV-2 recognizing CD8 T cells, we hope to shed light into the T cell immunity against SARS-CoV-2 and its change with age and post-infection.
Objective:
To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantity and quality in recovered COVID-19 patients.
Endpoints:
Primary Endpoint: 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. We plan to determine CD8 T cells that are responsive to SARS-CoV-2.
Secondary Endpoint: To determine the number and quality of SARSCoV-2 specific CD8
- Conditions
- COVID-19
- Keywords
- CD8 T Cell, COVID-19, Immune Response, Epitope, Aging, Natural History
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | COVID-19 recovered adult patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 month and 1 year data
Secondary outcomes (1)
Determine CD8 T cells that are responsive to SARS-CoV-2.
To determine the number and quality of SARS-CoV-2 specific CD8 T cells in relationship with the severity of COVID-19 disease.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start22 Sep 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nan-Ping P Weng, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565067
- Sponsor's protocol ID
- 10000140
- Other IDs
- 000140-AG
- Status last verified
- 8 Oct 2026
- First submitted
- 24 Sep 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NIA IRP are in discussion and a plan has not been finalized.
Publications
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.
PubMed 38145006
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans a Clinical Observation Trial
- ClinicalTrials.gov ID
- NCT04565067
- Acronym / sponsor ID
- 10000140
- Conditions
- COVID-19
- Keywords
- CD8 T Cell, COVID-19, Immune Response, Epitope, Aging, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
Detailed description
Study Description:
This study is to identify epitopes of SARS-CoV-2 that are recognized by CD8 T cells in the blood of healthy young and old participants as well as COVID-19 recovered. We will also measure general health factors using blood, saliva and urine samples. By analyzing the frequency, differentiation, and expansion of these SARS-CoV-2 recognizing CD8 T cells, we hope to shed light into the T cell immunity against SARS-CoV-2 and its change with age and post-infection.
Objective:
To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantity and quality in recovered COVID-19 patients.
Endpoints:
Primary Endpoint: 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. We plan to determine CD8 T cells that are responsive to SARS-CoV-2.
Secondary Endpoint: To determine the number and quality of SARSCoV-2 specific CD8
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –COVID-19 recovered adult patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine CD8 T cells that are responsive to SARS-CoV-2.
Time frame: 4 month and 1 year data
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.
1 secondary outcome
Determine CD8 T cells that are responsive to SARS-CoV-2.
Time frame: Ongoing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 38145006Yao 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.
- Individual participant dataSharing planned: Undecided. NIA IRP are in discussion and a plan has not been finalized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nan-Ping P Weng, M.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine CD8 T cells that are responsive to SARS-CoV-2. (time frame: 4 month and 1 year data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04565067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.