Coronavirus Disease 2019 (COVID-19) Pneumonia
Conditions
Keywords
Mesenchymal stem cells, COVID-19, Pneumonia
Brief summary
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
Detailed description
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
Interventions
OTHERMesenchymal stem cells
Intravenous infusion of Mesenchymal stem cells
Sponsors
Kanuni Sultan Suleyman Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Coronavirus Disease 2019 (COVID-19) patients with pneumonia 1.group: Intubated without comorbidity, 2.group: Intubated with comorbidity, 3.group: No intubated
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* aged 18-90 male or female * laboratory approve of RT-PCR (real-time reverse transcription polymerase chain reaction) with COVID-19 infection * pneumonia assessed by chest radiography or computed tomography * In accordance with any of the following: 1)Respiratory rate ≥ 30 times / min 2) oxygen saturation ≤ 93% 3) arterial pressure of oxygen/the fraction of inspired oxygen≤ 300mmHg, 4) pulmonary imaging of focus within 24-48 hours \> 50% progression * patients who remain unresponsive to medications administered according to Ministry of health guidelines * Patients who receiving invasive or non-invasive mechanical ventilation therapy in intensive care
Exclusion criteria
* Pregnancy * Any kind of cancer, severe liver disease * Failure to provide informed consent or comply with test requirements * Known allergy or hypersensitivity to MSCs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of clinical symptoms as respiratory distress or need for oxygen support | 3 months | Recovery of patient from mechanical and oxygen support |
| Change of cytokine storm parameters | 3 months | respiratory rates \< 30 times /min |
| Change of pulmonary functions | 3 months | Oxygen saturation \> 93% and pulmonary imaging of focus within 24-48 hours \> 50% progression |
| Change of clinical symptoms | 3 months | arterial pressure of oxygen/the fraction of inspired oxygen\>300mmHg |
Countries
Turkey (Türkiye)
Outcome results
None listed