Exosome therapy in ARDS patients

INTERVENTION: Intervention 1: Intervention group: Phase one: 12 patients with COVID‐19 in two groups of 6 with ARDS (each group includes intervention groups of 3). Phase Two: 60 patients with COVID‐19‐ARDS in two groups of 30 controls and intervention. Classified A and B in both control and intervention groups ‐ Exosome receiving group (intervention groups) • Injection material: Umbilical Cord Stem Cell‐derived exosomes• Injection rate: 100 million exosomes per kilogram of body weight • Injection carrier: Saline • Injection site: Intravenous. Intervention 2: Control group: Conventional treatments used in ARDS. CONDITION: Acute Respiratory Distress Syndrome due to COVID‐19. ; Acute respiratory distress syndrome U07.1 PRIMARY OUTCOME: Adverse reaction (AE) and severe adverse reaction (SAE). Timepoint: At the beginning of the intervention and on days 2, 3, 4, 7 and 14 after the intervention. Method of measurement: Physical examination of pulmonary function test. SECONDARY OUTCOME: Blood biochemistry (CRP). Timepoint: Baseline, day 5, 10, 20. Method of measurement: C‐reactive protein (CRP, mg/mL) concentration in the plasma will be measured. Murray lung injury score. Timepoint: Baseline and Days 1, 2, 3, 7, 14, 28, and 60 after intervention. Method of measurement: Clinical checklist. The minimum value is 0 and the maximum is 16. Higher scores mean a worse outcome. PaO2/FiO2. Timepoint: Baseline and Day 3, Day7, Day14, Day28, Day60. Method of measurement: Oxygen index: the ratio of alveolar oxygen partial pressure to fraction of inspired oxygen. The number of days the survivor was out of ICU. Timepoint: 60 Days. Method of measurement: The number of days the survivor was out of ICU. INCLUSION CRITERIA: Acute respiratory distress Syndrome of moderate to severe type (PaO2/ FiO2 <200mmHg) Age range between 18 to 65 years Men and Women No participation in another clinical trial during this study Patients who have given themselves and their families a full explanation of the study process and have obtained informed written consent Chest X‐ray showed bilateral infiltration with pulmonary edema Definitive infection with COVID‐19 confirmed by PCR