Acute Respiratory Distress Syndrome. Acute respiratory distress syndrome
Conditions
Interventions
Intervention group: Patients with resistant pneumonia caused by COVID-19 infection with acute symptoms of ARDS who have not responded to routine treatments. This group will receive about 10^6 cells/Kg
Sponsors
Modiriat Atiye Bahman Company
Motamed Cancer Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: COVID-19 infection confirmed with positive PCR test results with clinical signs including respiratory distress, cough, fever, decreased blood oxygen saturation, and imaging results in favor of ARDS Over 18 years of age Bilateral opacity of lungs on CT scan PaO2/FiO2 ratio < 200 Requires mechanical ventilation to increase oxygen saturation Written informed consent (according to the patient's condition, in case of unconscious consent, the consent will be obtained from the patient's guardian).
Exclusion criteria
Exclusion criteria: Less than 18 years of age More than 96 hours passed from the diagnosis of ARDS (Based on the Berlin definition of ARDS) Pregnancy or breastfeeding Presence of active malignancy which has been treated in the past two years Presence of severe and irreversible disease with a life expectancy of less than 6 months Moderate to severe liver failure (Childs-Pugh Score> 12) History of chronic lung disease with PaCO2>50 mm Hg or history of oxygen consumption at home Extensive trauma in the past 5 days History of lung transplantation Inability to provide informed consent or meet test conditions Class 3 or 4 pulmonary hypertension (WHO classification) History of pulmonary embolism or deep vein thrombosis (DVT) in the past three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of PLMSCs intravenous injection. Timepoint: During hospitalization up to 28 days after treatment. Method of measurement: Physical examinations and blood tests.;Change the amount of oxygen supply. Timepoint: Up to 28 days after treatment. Method of measurement: Measurement of PaO2 / FiO2.;Mortality. Timepoint: Up to 28 days after intervention. Method of measurement: The patients follow up.;Change in the severity of pneumonia. Timepoint: During hospitalization up to 28 days after treatment. Method of measurement: Physical examination - percentage of oxygen in the ventilator. | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigation of visceral insufficiency. Timepoint: Up to 28 days after transplantation. Method of measurement: Perform liver and kidney function tests on days 0, 7, 14 and 28.;C-reactive protein changes. Timepoint: Daily to +28. Method of measurement: Measurement of blood C-reactive protein.;Change in the number of lymphocytes. Timepoint: Day zero to week 12. Method of measurement: blood test.;Lung CT scan changes. Timepoint: Within 28 days after treatment. Method of measurement: Perform a CT scan of the lungs.;Duration of ICU admission. Timepoint: at the time of ICU discharge. Method of measurement: Number of admission days. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Ramin Sarrami Forooshani
Iranian academic center for education culture and research
Outcome results
None listed