Blood Collection Study From COVID-19 Convalescents Previously Hospitalized to Identify Immunogenic Viral Epitopes

Study Overview
=================
Brief Summary
-----------------
The COVID-19 pandemic is a global emergency threatening to take millions of lives in the United States and around the world. There is no current vaccine strategy against COVID-19 infection caused by a novel coronavirus named SARS-CoV-2. Studies with a related coronavirus called SARS-CoV-1 that caused the SARS outbreak in 2003 indicated that memory CD8+ T cells recognizing viral epitopes persisted for more than 6 years post infection while neutralizing antibodies and memory B cells were short-lived and were undetectable after a short period of time (Tang et al., 2011; Peng et al., 2006; Channappanavar et al., 2014). Thus, including viral epitopes that are recognized by memory CD8+ T cells is imperative for vaccines that can provide long-term immunity against SARS-CoV-2. In this study, blood samples from COVID-19 patients who have recovered from the infection will be used to identify the viral epitopes recognized by their memory CD8+ T cells. This will be accomplished using a genome-wide, high-throughput screening technology developed at Harvard Medical School (Kula et al., 2019) and licensed by the study sponsor, TScan Therapeutics. A 24,000-member library that tiles across all  100 viral isolates of SARS-CoV-2 that have been sequenced so far has already been synthesized at TScan. Blood samples from convalescent patients are urgently needed to identify T cell receptors and immunogenic viral epitopes on SARS-CoV-2. It is the hope that these data will inform development of a vaccine with the potential for long-lasting protection against SARS-CoV-2.

Official Title
-----------------
A Blood Collection Study From Volunteers Who Have Recovered From COVID-19 Infection to Identify Immunogenic Viral Epitopes in SARS-CoV-2

Conditions
-----------------
Identify the Viral Epitopes of Memory CD8 T Cells From Individuals That Have Recovered From SARS-CoV-2 Infection, Determine Which SARS-CoV-2 Proteins Are Frequently Recognized by T Cells in Patients With Varying HLA Types

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laboratory-confirmed diagnosis of COVID-19 performed by The Centers for Disease Control and Prevention (CDC) at a hospital using an FDA Emergency Use Authorized molecular assay for COVID-19 Age =>18 years at time of diagnosis of COVID-19 Time since discontinuation of isolation of =>14 day following CDC criteria Ability to understand and willingness to sign an informed consent document No anti-pyretic use for =>17 days Ability to undergo blood draw for 4 tubes of blood containing approximately 7.5 mL of blood each Ability to travel to an assigned lab for blood draw Ability to waive any claim to blood samples or data obtained for this study's purpose Exclusion Criteria: Any serious medical or psychiatric disorder that would interfere with the subject's safety Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent Known blood disorder that would increase the risk of infection or bleeding from a simple phlebotomy
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the viral epitopes of memory CD8+ T cells from individuals that have recovered from SARS-CoV-2 infection. |  | JUL2020 | 
| Determine which SARS-CoV-2 proteins are frequently recognized by T cells in patients with varying HLA types. |  | JUL2020 |