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

NCT04457726 | Unknown Phase 1

• 1 other identifier: COVID-T 2.0
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• National Early Warning Score (NEWS)

  one month

• Time to improvement by one category on a WHO ordinal scale

  one month

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

  two months

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

  two months

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

  two months

Study Arms (2)

Recipients with severe COVID-19

EXPERIMENTAL

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

Biological: SARS-CoV-2 Specific T Cells

Recipients with mild to moderate COVID-19

EXPERIMENTAL

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

Biological: SARS-CoV-2 Specific T Cells

Interventions

SARS-CoV-2 Specific T Cells BIOLOGICAL

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

Recipients with mild to moderate COVID-19; Recipients with severe COVID-19

Eligibility Criteria

• Age: 1 Year - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Rapidly progressive disease with anticipated life-expectancy \<72 hours
• Receiving steroid (\>0.5mg/kg methylprednisolone equivalent)
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Duke-NUS Graduate Medical School: collaborator
• National University Hospital, Singapore: collaborator
• Singapore General Hospital: collaborator
• Sengkang General Hospital: collaborator
• Changi General Hospital: collaborator

Study Sites (5)

Changi General Hospital

Singapore, Singapore

RECRUITING

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

National University Hospital

Singapore, Singapore

RECRUITING

Sengkang General Hospital

Singapore, Singapore

RECRUITING

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wing Hang Leung

  KK Hospital, SingHealth Duke NUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michaela Seng

CONTACT

82487085; bmtct@kkh.com.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2022
• Last Updated: July 7, 2020

Record last verified: 2020-06

Locations

SG (5)