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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:
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:
Dosage of Mesenchymal stem cells:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Intubated without comorbidity |
|
| Group 2 | Active Comparator | Intubated with comorbidity |
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| Group 3 | Active Comparator | No intubated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cells | Other | Intravenous infusion of Mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of clinical symptoms as respiratory distress or need for oxygen support | Recovery of patient from mechanical and oxygen support | 3 months |
| Change of cytokine storm parameters | respiratory rates < 30 times /min | 3 months |
| Change of pulmonary functions | Oxygen saturation > 93% and pulmonary imaging of focus within 24-48 hours > 50% progression | 3 months |
| Change of clinical symptoms | arterial pressure of oxygen/the fraction of inspired oxygen>300mmHg | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ebru Kaya, MD | Kanuni Sultan Suleyman Education and Training Hospital | Study Chair |
| Gursel Turgut, Prof Dr | Genkord | Study Chair |
| Ali Kocatas, MD | Kanuni Sultan Suleyman Education and Training Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences | Istanbul | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2020 | Jan 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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Coronavirus Disease 2019 (COVID-19) patients with pneumonia
1.group: Intubated without comorbidity, 2.group: Intubated with comorbidity, 3.group: No intubated
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| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |