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Adoptive T-Cell Therapy for Severe COVID-19
NCT04457726Phase 2
Key facts
- Status
- Unknown
- Start
- Jul 2020
- Primary completion
- Mar 2021
- Countries
- 1
- Sponsor
- KK Women's and Children's Hospital
- Modality
- Adoptive Cell Transfer
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, open-label trial of SARS-CoV-2 Specific T Cells in coronavirus disease 2019 (COVID-19) (2 arms), sponsored by KK Women's and Children's Hospital. Primary endpoint: Dose-Limiting Toxicities at Day 28. Status: unknown.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Severe COVID-19
Patients with severe disease indicators (hypoxia, organ failure)
Mild/Moderate COVID-19
Patients with mild to moderate disease at high risk of progression
03
Who it enrols
Patients aged 1-90 with confirmed SARS-CoV-2 infection (<72 hours prior). Inclusion requires either severe disease (hypoxia, respiratory failure, organ dysfunction) or mild-to-moderate disease with high risk factors (age >65, comorbidities). Exclusion includes rapidly progressive disease with life expectancy <72 hours and high-dose steroid use.
04
Endpoints
Primary
Dose-Limiting Toxicities
Secondary
National Early Warning Score
Time to improvement by one category on a WHO ordinal scale
Time-to-SARS-CoV-2 negativity
Duration of persistence of SARS-CoV-2 specific T cells
Time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome
Overall Survival
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