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

April 12, 2021 updated by: TScan Therapeutics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70124
        • Ochsner Clinic Foundation
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 convalescents previously hospitalized willing to donate blood. Both men and women and members of all races and ethnic groups are eligible for this protocol. It is expected that the mix of participants entering this study will reflect the demographics of the population affected by COVID-19.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Identify the viral epitopes of memory CD8+ T cells from individuals that have recovered from SARS-CoV-2 infection.
Time Frame: JUL2020
JUL2020
Determine which SARS-CoV-2 proteins are frequently recognized by T cells in patients with varying HLA types.
Time Frame: JUL2020
JUL2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TScan Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1586788

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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