COVID-19
Conditions
Keywords
SARS-CoV-2, Coronavirus disease
Brief summary
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
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.
Interventions
Donation of 1 unit of blood or leukapheresis
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate in production of SARS-CoV-2 specific T cells from convalescent donor | Two weeks (The expected duration of donor participation is 2 weeks) | 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. |
Countries
Singapore