Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
1 other identifier
observational
8
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2020
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 14, 2020
CompletedFirst Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedMarch 31, 2022
March 1, 2022
2.4 years
April 16, 2020
March 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success rate in production of SARS-CoV-2 specific T cells from convalescent donor
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.
Two weeks (The expected duration of donor participation is 2 weeks)
Study Arms (1)
Blood donors
Donors who had tested positive for SARS-CoV-2 in the past and have recovered from COVID-19 and are now suitable for blood donation.
Interventions
Eligibility Criteria
Potential donors are those who have recovered from COVID-19 and are willing to donate blood for other COVID-19 patients.
You may qualify if:
- 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
You may not qualify if:
- Do not meet the standard criteria for blood cell donation at National University Hospital or Singapore General Hospital.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KK Women's and Children's Hospitallead
- Singapore General Hospitalcollaborator
- National University Hospital, Singaporecollaborator
Study Sites (2)
National University Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Biospecimen
Blood from COVID-19 convalescent donors.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wing Hang Leung
KK Hospital, SingHealth, Duke-NUS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 17, 2020
Study Start
April 14, 2020
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
March 31, 2022
Record last verified: 2022-03