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

March 29, 2022 updated by: KK Women's and Children's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National University Hospital
        • Contact:
          • Lip Kun Tan
      • Singapore, Singapore
        • Recruiting
        • Singapore General Hospital
        • Contact:
          • Yeh Ching Linn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Potential donors are those who have recovered from COVID-19 and are willing to donate blood for other COVID-19 patients.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Blood donation from convalescent donor
Donation of 1 unit of blood or leukapheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate in production of SARS-CoV-2 specific T cells from convalescent donor
Time Frame: 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.
Two weeks (The expected duration of donor participation is 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Collaborators

National University Hospital, Singapore
Singapore General Hospital

Investigators

  • Principal Investigator: Wing Hang Leung, KK Hospital, SingHealth, Duke-NUS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2020

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-T 1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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