Coronavirus Disease 2019 (COVID-19) Pneumonia Clinical Trial
Official title:
A 8-Week Trial of Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia
Due to the cytokine storm that develops as a result of Coronavirus Disease 2019 (COVID-19) infection, some patients hospitalization to intensive care cause of pneumonia, Acute Respiratory Distress Syndrome (ARDS) and multiple organ failure. Mortality is higher in treatment-resistant cases. Purpose of this study: 1. Providing immune modulation by Stem Cell Transplantation and reducing the damage caused by cytokine storm to tissues and organs, 2. Correcting immunosuppression and fight against COVID-19 virus by editing B and T cells, 3. It is to accelerate healing in organ damage by increasing growth factors through mesenchymal stem cells. Primary outcome: Improvement of clinical symptoms, reduction of cytokine storm Secondary outcome: Recovery of patients; from mechanical ventilation
Study design and participants This study was a single-center open-label, randomized trial conducted at an Education and Training Hospital, Istanbul from May to July, 2020, and it was performed according to the Declaration of Helsinki and approved by the Ethics Committee and health ministry (No:2020.05.20). Written informed consent was obtained from all patients or their representatives when data were collected prospectively. Age, gender, mortality status, APACHE II score, number of days in ICU, procalcitonin and C-reactive protein values, leukocyte values, comorbid diseases, The cluster of differentiations 4 and 8 (CD4 and CD8), interleukin -2, interleukin -6, Tumor necrosis factor-alpha-beta levels will be recorded. Clinical results, changes in inflammatory and immune function levels, and side effects will be recorded. The patient's lung function and symptoms will be recorded after Mesenchymal Stem Cell transplantation. After treatment, lymphocyte, C-reactive protein, Tumor Necrosis alpha-beta levels , interleukin-6 levels will be recorded. Patients were divided into 3 groups: 1. group: Intubated without comorbidity (n:7) 2. group: Intubated with comorbidity (n:7) 3. group: No intubated (n:7) Dosage of Mesenchymal stem cells: 1. 1 million cell/kg iv--------------------------------------------------day 0 2. 1 million cell/kg iv -------------------------------------------------day 2 3. 1 million cell/kg iv -------------------------------------------------day 4 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04351152 -
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19
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Phase 3 |