Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 (THYTECH2) (THYTECH2)
Systemic Inflammatory Response Syndrome
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About this trial
This is an interventional treatment trial for Systemic Inflammatory Response Syndrome focused on measuring Immune Hyperactivation, Regulatory T cell, COVID-19, Advanced therapy, Immunotherapy, Th1-Th2 Balance
Eligibility Criteria
Inclusion Criteria: Patient over 18 to 60 years of age Patient Informed and non-opposed to the research by his medical doctor during hospitalization Patient diagnosed with severe COVID-19 pneumonia with Diagnosis of infection with SARS-CoV-2 virus by C-reactive Protein (CRP) Pulmonary abnormalities consistent with pneumonia by chest imaging (radiograph or scan) Who have one or more of the following requirements: SpO2≤94% on room air, PaO2/FiO2≤ 300 or SaO2/FiO2≤ 350 Patients with signs of cytokine release or macrophage activation syndrome with one of the following conditions: or leukopenia <800/ul or D-dimer >1500 ng/ml or IL6 > 40 pg/ml or ferritin >300 ng/ml or CRP >3 mg/dl or LDH >300 UI/L Exclusion Criteria: Pregnancy or breast feeding Body mass index >35 Patients not expected to survive 48 hours after enrolment based on clinical assessment Patients with an extracorporeal respiratory support Neutropenia (absolute neutrophil count <1000/uL) Thrombocytopenia (absolute neutrophil count <50000/uL) Positive serology for HBV, HCV, or HIV at Screening Sepsis or severe pneumonia bacterial or suspected serious infection Life expectancy of less than 6 months due to other pathologies History of significant underlying pulmonary disease requiring oxygen therapy prior to COVID-19 infection. Patients with a history of autoimmune diseases Patients with a history of hematopoietic neoplasia or oncology disease Patients with a history of hematopoietic or solid organ transplant Patients with a congenital or induced immunodeficiency Patients received thymoglobulin, basiliximab or any anti-T-cell therapies within 6 moths prior to the screening visit Patients received other cell therapy in the last 12 months Patients received intravenous immunoglobulin (IVIg) within 5 moths prior to the screening visit Patients who have participated or is participating in a clinical research study evaluating COVID-19 within 30 days prior to the screening visit
Sites / Locations
- Hospital General Universitario Gregorio MarañonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
No Intervention
Experimental
No Intervention
Phase A: 5.000.000 thyTreg /kg
Phase A: standard of care
Phase B: 10.000.000 thyTreg /kg
Phase B: standard of care
Allogeneic thyTreg 5.000.000
Standard of care
Allogeneic thyTreg 10.000.000
Standard of care