Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19

Study Overview
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Brief Summary
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The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously for the treatment of severe SARS-CoV-2 infections.

Detailed Description
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A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine or specific treatment has been proven to be effective. While waiting for vaccine to be developed, passive immunity can be acquired immediately by adoptive transfer of SARS-CoV-2 specific T cells from convalescent donors into newly infected patients. The aim of this protocol is to demonstrate the feasibility of preparing SARS-CoV-2 specific T cells from convalescent donors for urgent clinical use. The specific hypothesis is that SARS-CoV-2 specific T cells can be isolated from the blood of convalescent donors rapidly and efficiently using SARS-CoV-2 specific peptides and an automated medical device for emergent treatment of severe COVID-19 disease. A minimum of 8 convalescent donors will be recruited from Singapore to attain HLA sharing with at least 90% of the general population.

Official Title
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Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Other: Blood donation from convalescent donor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 to 65 Had a history of COVID-19 with documented positive test for SARS-CoV-2 in the past Has recovered from COVID-19 and is now suitable for blood donation, fulfilling all standard blood donor criteria Negative test for SARS-CoV-2 currently Exclusion Criteria: Do not meet the standard criteria for blood cell donation at National University Hospital or Singapore General Hospital.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood donors<br>Donors who had tested positive for SARS-CoV-2 in the past and have recovered from COVID-19 and are now suitable for blood donation. | Other: Blood donation from convalescent donor<br>* Donation of 1 unit of blood or leukapheresis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate in production of SARS-CoV-2 specific T cells from convalescent donor | Success of SARS-CoV-2 specific T cell manufacturing is defined as production of >200,000 T cells per donor. The success rate will be summarized descriptively. | Two weeks (The expected duration of donor participation is 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, Coronavirus disease