Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19

COVID-19 Clinical Trial

Official title:

Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04351659
• Other study ID #: COVID-T 1.0
• Status: Recruiting
• Start date: April 14, 2020
• Est. completion date: September 2022

Study information

• Verified date: March 2022
• Source: KK Women's and Children's Hospital
• Contact: Michaela Seng
• Phone: 82487085
• Email: childhoodcancer[@]kkh.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine or specific treatment 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 aim of this protocol is to demonstrate the feasibility of preparing SARS-CoV-2 specific T cells from convalescent donors for urgent clinical use. The specific hypothesis is that SARS-CoV-2 specific T cells can be isolated from the blood of convalescent donors rapidly and efficiently using SARS-CoV-2 specific peptides and an automated medical device for emergent treatment of severe COVID-19 disease.

A minimum of 8 convalescent donors will be recruited from Singapore to attain HLA sharing with at least 90% of the general population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Do not meet the standard criteria for blood cell donation at National University Hospital or Singapore General Hospital.

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Blood donation from convalescent donor
Donation of 1 unit of blood or leukapheresis

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	National University Hospital, Singapore, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)