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

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

• INCLUSION CRITERIA:

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.

Exclusion criteria

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.