Status:
UNKNOWN
Part Two of Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
Lead Sponsor:
KK Women's and Children's Hospital
Collaborating Sponsors:
Duke-NUS Graduate Medical School
National University Hospital, Singapore
Conditions:
COVID-19
Eligibility:
All Genders
1-90 years
Phase:
PHASE1
PHASE2
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 specifi...
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 has been proven to be effective. While waiting for vacci...
Eligibility Criteria
Inclusion
- 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
- Rapidly progressive disease with anticipated life-expectancy \<72 hours
- Receiving steroid (\>0.5mg/kg methylprednisolone equivalent)
- Pregnancy
- Breastfeeding
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04457726
Start Date
July 1 2020
End Date
December 1 2022
Last Update
July 7 2020
Active Locations (5)
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1
Changi General Hospital
Singapore, Singapore
2
KK Women's and Children's Hospital
Singapore, Singapore
3
National University Hospital
Singapore, Singapore
4
Sengkang General Hospital
Singapore, Singapore