Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04457726
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Duke-NUS Graduate Medical School
National University Hospital, Singapore
Singapore General Hospital
Sengkang General Hospital
Changi General Hospital
Information provided by (Responsible Party):
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 and these cells are safe and effective for the treatment of severe SARS-CoV-2 infections.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: SARS-CoV-2 Specific T Cells Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Part Two of Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Recipients with severe COVID-19
Recipients who are confirmed positive by SARS-CoV-2 testing and have severe COVID-19.
Biological: SARS-CoV-2 Specific T Cells
Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously.

Experimental: Recipients with mild to moderate COVID-19
Recipients who are confirmed positive by SARS-CoV-2 testing and have mild to moderate COVID-19.
Biological: SARS-CoV-2 Specific T Cells
Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously.




Primary Outcome Measures :
  1. Dose-Limiting Toxicities [ Time Frame: till Day 28 after infusion of SARS-CoV-2 specific T cells ]
    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 :
  1. National Early Warning Score (NEWS) [ Time Frame: one month ]
    Measured by change in daily NEWS score after infusion of SARS-CoV-2 specific T cells

  2. Time to improvement by one category on a WHO ordinal scale [ Time Frame: one month ]
    Measured by time-to-improvement by one category on a WHO ordinal scale after infusion of SARS-CoV-2 specific T cells

  3. Time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells [ Time Frame: two months ]
    Measured by time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells

  4. Duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood circulation [ Time Frame: two months ]
    Measured by the duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood

  5. Time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion [ Time Frame: two months ]
    Measured by the time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion

  6. Overall survival (OS) at 3 months after infusion of SARS-CoV-2 specific T cells [ Time Frame: three months ]
    Measured by the proportion of recipients surviving at 3 months after infusion of SARS-CoV-2 specific T cells



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04457726


Contacts
Layout table for location contacts
Contact: Michaela Seng 82487085 bmtct@kkh.com.sg

Locations
Layout table for location information
Singapore
Changi General Hospital Recruiting
Singapore, Singapore
Contact: Roshni Sadashiv Gokhale         
KK Women's and Children's Hospital Recruiting
Singapore, Singapore
Contact: Michaela Seng         
National University Hospital Recruiting
Singapore, Singapore
Contact: Lip Kun Tan         
Sengkang General Hospital Recruiting
Singapore, Singapore
Contact: Jiashen Loh         
Singapore General Hospital Recruiting
Singapore, Singapore
Contact: Yeh Ching Linn         
Sponsors and Collaborators
KK Women's and Children's Hospital
Duke-NUS Graduate Medical School
National University Hospital, Singapore
Singapore General Hospital
Sengkang General Hospital
Changi General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Wing Hang Leung KK Hospital, SingHealth Duke NUS
Layout table for additonal information
Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT04457726    
Other Study ID Numbers: COVID-T 2.0
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No