Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Duke-NUS Graduate Medical School | OTHER |
| National University Hospital, Singapore | OTHER |
| Singapore General Hospital | OTHER |
| Sengkang General Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine 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 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. Part Two of this project is to assess the safety and efficacy of these T cells in patients with COVID-19.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recipients with severe COVID-19 | Experimental | Recipients who are confirmed positive by SARS-CoV-2 testing and have severe COVID-19. |
|
| Recipients with mild to moderate COVID-19 | Experimental | Recipients who are confirmed positive by SARS-CoV-2 testing and have mild to moderate COVID-19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 Specific T Cells | Biological | Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicities | Dose-limiting toxicities are defined as >Grade 3 Common Toxicity Criteria associated with the therapeutic cells. Toxicity rate will be summarized descriptively. | till Day 28 after infusion of SARS-CoV-2 specific T cells |
| Measure | Description | Time Frame |
|---|---|---|
| National Early Warning Score (NEWS) | Measured by change in daily NEWS score after infusion of SARS-CoV-2 specific T cells | one month |
| Time to improvement by one category on a WHO ordinal scale |
Not provided
Inclusion Criteria:
Group 1: Severe disease, defined by one or more of the following:
Group 2: Mild to moderate disease, at high risk of progression to severe disease. For example,
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michaela Seng | Contact | 82487085 | bmtct@kkh.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Wing Hang Leung | KK Hospital, SingHealth Duke NUS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Recruiting | Singapore | Singapore |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| OTHER |
| Changi General Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Measured by time-to-improvement by one category on a WHO ordinal scale after infusion of SARS-CoV-2 specific T cells
| one month |
| Time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells | Measured by time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells | two months |
| Duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood circulation | Measured by the duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood | two months |
| Time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion | Measured by the time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion | two months |
| Overall survival (OS) at 3 months after infusion of SARS-CoV-2 specific T cells | Measured by the proportion of recipients surviving at 3 months after infusion of SARS-CoV-2 specific T cells | three months |
| KK Women's and Children's Hospital | Recruiting | Singapore | Singapore |
|
| National University Hospital | Recruiting | Singapore | Singapore |
|
| Sengkang General Hospital | Recruiting | Singapore | Singapore |
|
| Singapore General Hospital | Recruiting | Singapore | Singapore |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |