Acute Respiratory Distress Syndrome of COVID-19. COVID-19
Conditions
Interventions
Intervention 1: Intervention group:Intervention group: The intervention group 1, Patients will receive Six doses of Exosomes. One doses of 10×10e10 (±10%) Exosomes will intravenously infuse as a norm
Sponsors
Omid Cell and Tissue center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Confirmation of 2019-nCoV infection by RT-PCR Diagnosis of ARDS according to the Berlin definition of ARDS Requiring supplemental oxygen, PaO2/oxygen absorption concentration (FiO2) = 300MMHG Pulmonary imaging shows that the focused progress > 50% in 24-48 hours Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU <48 hours SOFA score between 2-3 point Pneumonia that is judged by chest radiograph or CT
Exclusion criteria
Exclusion criteria: Severe allergies or allergies after 1st injection to stem cell preparations and their components Patients with a malignant tumor, other serious systemic diseases, and psychosis Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus Patients with previous history of pulmonary embolism Liver or kidney SOFA score of more than 3 points; combined with other organ failure (need organ support), Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30) Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia Continuous use of immunosuppressive agents or organ transplants in the past 6 months In vitro life support (ECMO, ECCO2R, RRT) Pregnant or lactating women Uncontrolled underlying disease Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events assesment. Timepoint: At the same time of each intervention, 12 hours after each intervention, on days 6, 7, 14 and 28 after the first intervention. Method of measurement: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarkers concentrations in plasma. Timepoint: At baseline, 7, 14, 28 days after the first intervention. Method of measurement: Biochemical examination.;Respiratory efficacy. Timepoint: From baseline to day 7. Method of measurement: Evaluated by the increase in PaO2/FiO2 ratio.;Intensive care unit-free days. Timepoint: Up to day 8. Method of measurement: Number of day.;Change in clinical symptoms. Timepoint: At Baseline, simultaneously with each intervention and on days 5, 6, 7, 14 after the first intervention. Method of measurement: Evaluation of Pneumonia Improvement. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Vasei
Tehran University of Medical Sciences
Outcome results
None listed