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.
Biological: SARS-CoV-2 Specific T Cells
Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously.
Inclusion Criteria:
- Age 1 to 90 years
- Tested positive for SARS-CoV-2 <72 hours prior to enrolment
- Predicted to have high chance of mortality:
Group 1: Severe disease, defined by one or more of the following:
- Dyspnea
- Respiratory frequency ≥ 30/min
- Blood oxygen saturation ≤ 93%
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
- Lung infiltrates > 50% within 24 to 48 hours
- Respiratory failure
- Septic shock
- Multiple organ dysfunction or failure
Group 2: Mild to moderate disease, at high risk of progression to severe disease. For
example,
- Age > 65 years
- Chronic health conditions such as chronic lung disease, cardiovascular disease,
diabetes mellitus, obesity, end-stage renal disease or liver disease
Exclusion Criteria:
- Rapidly progressive disease with anticipated life-expectancy <72 hours
- Receiving steroid (>0.5mg/kg methylprednisolone equivalent)
- Pregnancy
- Breastfeeding
Changi General Hospital
Singapore, Singapore
KK Women's and Children's Hospital
Singapore, Singapore
National University Hospital
Singapore, Singapore
Sengkang General Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Michaela Seng
82487085
bmtct@kkh.com.sg
Wing Hang Leung, Principal Investigator
KK Hospital, SingHealth Duke NUS