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

Primary Purpose

COVID-19

Status

Unknown status

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

SARS-CoV-2 Specific T Cells

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

1 Year - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Changi General HospitalRecruiting
KK Women's and Children's HospitalRecruiting
National University HospitalRecruiting
Sengkang General HospitalRecruiting
Singapore General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Recipients with severe COVID-19

Recipients with mild to moderate COVID-19

Arm Description

Recipients who are confirmed positive by SARS-CoV-2 testing and have severe COVID-19.

Recipients who are confirmed positive by SARS-CoV-2 testing and have mild to moderate COVID-19.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

National Early Warning Score (NEWS)

Measured by change in daily NEWS score after infusion of SARS-CoV-2 specific T cells

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

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

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

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

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

Full Information

NCT ID

NCT04457726

First Posted

July 2, 2020

Last Updated

July 2, 2020

Sponsor

KK Women's and Children's Hospital

Collaborators

Duke-NUS Graduate Medical School, National University Hospital, Singapore, Singapore General Hospital, Sengkang General Hospital, Changi General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04457726

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2020 (Anticipated)

Primary Completion Date

March 2021 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

KK Women's and Children's Hospital

Collaborators

Duke-NUS Graduate Medical School, National University Hospital, Singapore, Singapore General Hospital, Sengkang General Hospital, Changi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 and these cells are safe and effective 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Recipients with severe COVID-19

Arm Type

Experimental

Arm Description

Recipients who are confirmed positive by SARS-CoV-2 testing and have severe COVID-19.

Arm Title

Recipients with mild to moderate COVID-19

Arm Type

Experimental

Arm Description

Recipients who are confirmed positive by SARS-CoV-2 testing and have mild to moderate COVID-19.

Intervention Type

Biological

Intervention Name(s)

SARS-CoV-2 Specific T Cells

Intervention Description

Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously.

Primary Outcome Measure Information:

Title

Dose-Limiting Toxicities

Description

Dose-limiting toxicities are defined as >Grade 3 Common Toxicity Criteria associated with the therapeutic cells. Toxicity rate will be summarized descriptively.

Time Frame

till Day 28 after infusion of SARS-CoV-2 specific T cells

Secondary Outcome Measure Information:

Title

National Early Warning Score (NEWS)

Description

Measured by change in daily NEWS score after infusion of SARS-CoV-2 specific T cells

Time Frame

one month

Title

Time to improvement by one category on a WHO ordinal scale

Description

Measured by time-to-improvement by one category on a WHO ordinal scale after infusion of SARS-CoV-2 specific T cells

Time Frame

one month

Title

Time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells

Description

Measured by time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells

Time Frame

two months

Title

Duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood circulation

Description

Measured by the duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood

Time Frame

two months

Title

Time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion

Description

Measured by the time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion

Time Frame

two months

Title

Overall survival (OS) at 3 months after infusion of SARS-CoV-2 specific T cells

Description

Measured by the proportion of recipients surviving at 3 months after infusion of SARS-CoV-2 specific T cells

Time Frame

three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michaela Seng

Phone

82487085

bmtct@kkh.com.sg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wing Hang Leung

Organizational Affiliation

KK Hospital, SingHealth Duke NUS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changi General Hospital

City

Singapore

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roshni Sadashiv Gokhale

Facility Name

KK Women's and Children's Hospital

City

Singapore

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michaela Seng

Facility Name

National University Hospital

City

Singapore

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lip Kun Tan

Facility Name

Sengkang General Hospital

City

Singapore

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiashen Loh

Facility Name

Singapore General Hospital

City

Singapore

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yeh Ching Linn

12. IPD Sharing Statement

Learn more about this trial

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

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