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

• Conditions: COVID-19
• Interventions: Other: Blood donation from convalescent donor

• Registration Number: NCT04351659
• Lead Sponsor: KK Women's and Children's Hospital

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.

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 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.

Study Timeline

• Study Start: 2020-04-14
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood donors	Blood donation from convalescent donor	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.

Primary Outcome Measures

Name	Time	Method
Success rate in production of SARS-CoV-2 specific T cells from convalescent donor	Two weeks (The expected duration of donor participation is 2 weeks)	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.

Trial Locations

Locations (2)

National University Hospital; 🇸🇬 Singapore, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Singapore