Efficacy and safety of Jusvinza treatment in patients with acute respiratory distress syndrome. Phase II/III

INTERVENTION: Administration, Intravenous Jusvinza Peptides Phase 2: two Jusvinza treatment groups and one Placebo group will be included. Group 1 (experimental). Jusvinza 1 mg every 8 hours intravenously. Group 2 (experimental). Jusvinza 2 mg every 8 hours intravenously. Group 3 (Control). Patients who will receive 1 mg of placebo every 8 hours intravenously. Phase 3: one treatment group and one placebo group will be included. Group 1 (experimental). Jusvinza dose that shows best effect results in Phase 2, every 8 hours intravenously. Group 2 (Control). Patients who will receive the same dose as Group 1 but placebo, every 8 hours intravenously. In both phases, the groups will maintain the treatment until 48 hours after the withdrawal of mechanical ventilation or for a maximum period of 15 days. Subjects will be followed up 28 days after starting treatment. Placebos Respiration, Artificial CONDITION: Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases PRIMARY OUTCOME: Phase 2: ; 1) PaO2/FiO2 ratio (measurement of the value in mmHg of the PaO2/FiO2 ratio). Measurement time: to the 7th day from randomization.; 2) Time of invasive mechanical ventilation (Number of days with invasive mechanical ventilation). Measurement time: from randomization.; Phase 3: Mortality (Subject alive or deceased). Measurement time: at 28 days from randomization.; SECONDARY OUTCOME: 1) Respiratory function variables (Peak inspiratory pressure (value returned by the mechanical ventilator in cm H2O), Plateau pressure (value returned by the mechanical ventilator in cm H2O), Positive end‐expiratory pressure (PEEP) (value returned by mechanical ventilator in cm H2O), Respiratory conduction pressure (Calculated as the difference between plateau pressure and PEEP. Value in cm H2O), Tidal volume (value given by the mechanical ventilation equipment in mL), Minute volume ( value given by the mechanical ventilation team in L. It is calculated as: tidal volume * respiratory frequency), Dynamic compliance (compliance) of the respiratory system (value given by the mechanical ventilation team in mL/ cm H2O. It is calculated as the volume current/ (peak inspiratory pressure – PEEP), Static compliance (compliance) of the respiratory system (value given by the mechanical ventilation team in mL/ cm H2O, It is calculated as the tidal volume/ (pressure plateau – PEEP), Total respiratory rate (value given by the mechanical ventilation equipment in breaths/minute), Mechanical power (Value measured in Joules. It is calculated: a) For volume‐controlled mode: 0.098 * VC * (PIP – Pcond/2) * FR, b) For pressure‐controlled mode: 0.098 * VC * (Pcond + PEEP) * FR), Inde Xof ventilation (Calculated as follows: Ventilation rate = Respiratory rate × (Peak inspiratory pressure ‐ PEEP) × PaCO2/ 1000)), Inspiratory fraction of oxygen (value given by the mechanical ventilation team in %). Measuring time: Daily. At baseline and until the patient is withdrawn from mechanical ventilation (up to 28 days of follow‐up).; 2) Gasometric variables (pH (value given by gasometry), oxygen saturation in arterial blood (value given by gasometry in %), partial pressure of oxygen in arterial blood (value given by gasometry in mm Hg), partial pressure of carbon dioxide in arterial blood (value given by blood gases in mm Hg), bicarbonate (value given by blood gases in mm Hg)). Measurement time: At the beginning and until the patient is withdrawn from invasive mechanical ventilation (up to 28 days of follow‐up).; 3) Radiographic evaluation of ARDS (RALE Scale (Presence of pulmonary opacities (yes or no), Type of pulmonary opacity (consolidation or ground glass pattern), RALE score according to affected areas (0 to 8 points), Other findings Measurement time: At baseline, 72 hours, 5th day, 7th day and 10th day from randomization and when clinically indicated.; 4) Clinical response variables (SOFA Scale (Central Nervous System Score according to the Glasgow scale, Respiration System Score according to PaO2/FIO2 (mm Hg) value), Coagulation criteria score according to Platelet count value, Function criteria score hepatica according to total Bilirubin value (µmol/L), Cardiovascular System criteria score according to a) Mean arterial pressure value, b) Use of vasoactive drugs (dopamine, dobutamine, norepinephrine, adrenaline) (yes or no), c) Type and dose of vasoactive drugs used. Renal function criteria score according to a) Creatinine concentration in µmol/L, b) Diuresis in 24 hours in ml. SOFA scale total score value. Evaluation of organic dysfunction according to the total score). Measurement time: At baseline, 72 hours, 5th day, 7th day and 10th day from randomization. Need for vasopressor amines (Use of vasopressor amines (yes or no), Type and dose). Need for inotropic amines (yes or no, type and dose). Need for renal replacement therapy (yes or no, type and dose). ICU‐acquired sepsis ((yes or no). Measurement time: from randomization. Type of sepsis). Need for endotracheal intubation in subjects with non‐invasive ventilation (yes or no). ICU stay (days). Measurement time: from randomization to discharge from the ICU. Hospital stay (days in hospital). Measurement time: from randomization to discharge. Hospital mortality (Status of the subject at hospital discharge (alive or deceased), Cause of death, Place of death (inside or outside the ICU)).; 5) Laboratory, molecular and cellular variables (Proinflammatory cytokines (Value of the concentration of IL‐1, IL‐6 and TNFa (pg/mL)). Measurement time: At the beginning, 5th day and 10th day from the randomization and when clinically indicated Inflammatory biomarkers (WBC count (x109/L), Neutrophils%, Lymphocytes%, Monocytes%, Eosinophils%, Basophils%, Platelet count (x109/L), Regulatory T cells (x109/L ), C‐reactive protein (mg/L), Procalcitonin (ng/ml), Ferritin (ng/ml), Activated partial thromboplastin time, Prothrombin time, Fibrinogen (mg/L), Lactate (mmol/L), Globulins total values (g/L), LDH (U/L), quantitative D‐dimer (ug/ml) Measurement time: At baseline, 5th day and 10th day from randomization and when clinically indicated Lipid profile (Value of the concentration in blood of total Cholesterol (mmol/L), Triglycerides (mmol/L), HDL‐cholesterol (mmol/L), LDL‐cholesterol (mmol/L)). Measurement time: At the beginning, 5th day and 10th day from randomization and when clinically indicated.; 6) Safety variables (Adverse events (Yes or No), Type, Intensity (mild, moderate, severe), Severity (Serious or non‐serious), Duration (start and end dates of each AE), Attitude followed before the appearance of the adverse event (it will be recorded if there were no changes or definitive interruption of treatment), Result (recovered, improved, persists or leaves sequelae), Causal relationship (very likely, probable, possible, unlikely, not related, not evaluable), Treatment indicated for the adverse event (the treatment that each patient will receive for the AE that occurs will be specified.) Measurement time: from the start of treatment until the final evaluation.; 7) Control variables (Age (years), Se X(female or male), Personal pathological history (APP) (It will be collected through the dichotomous variable: Yes or No for chronic diseases such as diabetes mellitus (DM), obesity, hypertension blood pressure, dyslipidemia, ischemic heart disease, heart failure, bronchial asthma, kidney disease, Cancer, HIV/AIDS, Infection in the last 30 days (viral or bacterial) with the option of other APPs for other history), Clinical site (Name of the site clinic (hospital or Institute) to which INCLUSION CRITERIA: 1) Patients diagnosed with acute respiratory distress syndrome (according to the Berlin criteria) 2) Patients over 19 years of age or older. 3) Patients with invasive or non‐invasive mechanical ventilation.