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

COVID-19 Clinical Trial

Official title:

Part Two of 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: NCT04457726
• Other study ID #: COVID-T 2.0
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: KK Women's and Children's Hospital
• Contact: Michaela Seng
• Phone: 82487085
• Email: bmtct[@]kkh.com.sg
• Is FDA regulated: No
• Study type: Interventional

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 and these cells are safe and effective 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 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 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 and these cells are safe and effective for the treatment of severe SARS-CoV-2 infections. Part Two of this project is to assess the safety and efficacy of these T cells in patients with COVID-19.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 2022
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 90 Years

Eligibility

Inclusion Criteria:

• Age 1 to 90 years

• Tested positive for SARS-CoV-2 <72 hours prior to enrolment

• Predicted to have high chance of mortality:

Group 1: Severe disease, defined by one or more of the following:

• Dyspnea

• Respiratory frequency = 30/min

• Blood oxygen saturation = 93%

• Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300

• Lung infiltrates > 50% within 24 to 48 hours

• Respiratory failure

• Septic shock

• Multiple organ dysfunction or failure

Group 2: Mild to moderate disease, at high risk of progression to severe disease. For example,

• Age > 65 years

• Chronic health conditions such as chronic lung disease, cardiovascular disease, diabetes mellitus, obesity, end-stage renal disease or liver disease

Exclusion Criteria:

• Rapidly progressive disease with anticipated life-expectancy <72 hours

• Receiving steroid (>0.5mg/kg methylprednisolone equivalent)

• Pregnancy

• Breastfeeding

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• SARS-CoV-2 Specific T Cells
Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously.

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Sengkang General Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (6)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	Changi General Hospital, Duke-NUS Graduate Medical School, National University Hospital, Singapore, Sengkang General Hospital, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-Limiting Toxicities	Dose-limiting toxicities are defined as >Grade 3 Common Toxicity Criteria associated with the therapeutic cells. Toxicity rate will be summarized descriptively.	till Day 28 after infusion of SARS-CoV-2 specific T cells
Secondary	National Early Warning Score (NEWS)	Measured by change in daily NEWS score after infusion of SARS-CoV-2 specific T cells	one month
Secondary	Time to improvement by one category on a WHO ordinal scale	Measured by time-to-improvement by one category on a WHO ordinal scale after infusion of SARS-CoV-2 specific T cells	one month
Secondary	Time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells	Measured by time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells	two months
Secondary	Duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood circulation	Measured by the duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood	two months
Secondary	Time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion	Measured by the time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion	two months
Secondary	Overall survival (OS) at 3 months after infusion of SARS-CoV-2 specific T cells	Measured by the proportion of recipients surviving at 3 months after infusion of SARS-CoV-2 specific T cells	three months