Acute Respiratory Distress Syndrome of COVID-19. COVID-19
Conditions
Interventions
Intervention 1: Intervention group: The intervention group 1, Patients will receive three doses of MSCs. Two doses of 100×10e6 (±10%) cells will intravenously infuse as a normally dropped single dose
Sponsors
Iranian academic center for education culture and research
National Institute for Medical Research Development
Eligibility
Sex/Gender
All
Age
18 Years to 65 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, OR Pneumonia that is judged by chest radiograph or CT 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
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 Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections) 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 underling disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events assesment. Timepoint: At the same time of each intervention, 24 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.;Blood oxygen saturation. 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. | — |
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 ContactMorteza Zarrabi
Royan Institute
Outcome results
None listed