Blood Collection Study From COVID-19 Convalescents Previously Hospitalized to Identify Immunogenic Viral Epitopes
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ClinicalTrials.gov Identifier: NCT04397900 |
Recruitment Status :
Recruiting
First Posted : May 21, 2020
Last Update Posted : June 16, 2020
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Condition or disease |
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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 |
Study Type : | Observational |
Estimated Enrollment : | 80 participants |
Observational Model: | Other |
Time Perspective: | Retrospective |
Official Title: | A Blood Collection Study From Volunteers Who Have Recovered From COVID-19 Infection to Identify Immunogenic Viral Epitopes in SARS-CoV-2 |
Actual Study Start Date : | April 9, 2020 |
Estimated Primary Completion Date : | July 1, 2020 |
Estimated Study Completion Date : | July 2020 |
- Identify the viral epitopes of memory CD8+ T cells from individuals that have recovered from SARS-CoV-2 infection. [ Time Frame: JUL2020 ]
- Determine which SARS-CoV-2 proteins are frequently recognized by T cells in patients with varying HLA types. [ Time Frame: JUL2020 ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397900
Contact: Kenneth J Olivier, PhD | 617-949-1575 | kolivier@tscan.com |
United States, Louisiana | |
Ochsner Clinic Foundation | Recruiting |
New Orleans, Louisiana, United States, 70124 | |
Contact: Abby Richardson 866-624-7637 abby.richardson@ochsner.org | |
United States, New Jersey | |
Atlantic Health System | Recruiting |
Morristown, New Jersey, United States, 07960 | |
Contact: Joana Achanfuo-Yeboah, CRA 973-886-7801 Joana.Achanfuo-Yeboah@atlantichealth.org |
Responsible Party: | TScan Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT04397900 |
Other Study ID Numbers: |
1586788 |
First Posted: | May 21, 2020 Key Record Dates |
Last Update Posted: | June 16, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infection |