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

KK Women's and Children's Hospital

Status: Enrolling

Conditions: COVID-19

Treatments: Other: Blood donation from convalescent donor

Study type: Observational

Funder types: Other

Identifiers

NCT04351659

COVID-T 1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

8 participants in 1 patient group

Blood donors

Description:

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.

Treatment:

Other: Blood donation from convalescent donor