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drug606 | Collection of Biological Samples Wiki | 1.00 |
drug2400 | Symptom and Exposure Surveys Wiki | 1.00 |
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There is one clinical trial.
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 and these cells are safe and effective for the treatment of severe SARS-CoV-2 infections.
Description: Dose-limiting toxicities are defined as >Grade 3 Common Toxicity Criteria associated with the therapeutic cells. Toxicity rate will be summarized descriptively.
Measure: Dose-Limiting Toxicities Time: till Day 28 after infusion of SARS-CoV-2 specific T cellsDescription: Measured by change in daily NEWS score after infusion of SARS-CoV-2 specific T cells
Measure: National Early Warning Score (NEWS) Time: one monthDescription: Measured by time-to-improvement by one category on a WHO ordinal scale after infusion of SARS-CoV-2 specific T cells
Measure: Time to improvement by one category on a WHO ordinal scale Time: one monthDescription: Measured by time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells
Measure: Time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells Time: two monthsDescription: Measured by the duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood
Measure: Duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood circulation Time: two monthsDescription: Measured by the time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion
Measure: Time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion Time: two monthsDescription: Measured by the proportion of recipients surviving at 3 months after infusion of SARS-CoV-2 specific T cells
Measure: Overall survival (OS) at 3 months after infusion of SARS-CoV-2 specific T cells Time: three months