Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans
Study Details
Study Description
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.
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Condition or Disease | Intervention/Treatment | Phase |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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1 COVID-19 recovered adult patients |
Outcome Measures
Primary Outcome Measures
- Determine CD8 T cells that are responsive to SARS-CoV-2. [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.
Secondary Outcome Measures
- Determine CD8 T cells that are responsive to SARS-CoV-2. [Ongoing]
To determine the number and quality of SARS-CoV-2 specific CD8 T cells in relationship with the severity of COVID-19 disease.
Eligibility Criteria
Criteria
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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Ability of subject to understand the study and stated willingness to comply with all study procedures and availability for the duration of the study.
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Male or female, aged 18 years or older.
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Able to speak and read English.
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Willingness and ability to come to the NIA Clinical Research Unit at MedStar Harbor Hospital in Baltimore for study procedures.
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Proof of positive SARS-CoV-2 testing exhibiting no current clinical symptoms.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
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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.
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Unable to provide informed consent
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Current use of steroids, immunosuppressive medications, radiation therapy, or chemotherapy medications.
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Pregnancy.
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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:
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Symptoms of a viral infection on visit 1 (defer until resolved).
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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.
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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.
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Infection or Fever: Deferred until 2 weeks after antibiotics are completed and /or volunteer is feeling well.
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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.
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Treatment with another investigational drug or other intervention within 14 days of visit 1 per the discretion of the Principal Investigator.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | National Institute of Aging, Clinical Research Unit | Baltimore | Maryland | United States | 21224 |
Sponsors and Collaborators
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Nan-Ping Weng, M.D., National Institute on Aging (NIA)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10000140
- 000140-AG