Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Safety
1. Serious Adverse Events-SAE (Percentage of patients who developed SAE according to the CTCAE v5.0 classification). Measurement time: During hospitalized time
2. Clinical and laboratory adverse events (The frequency distribution of AD appearance, type of event and body system will be determined. Duration, intensity, result, attitude and causal relationship of the AE will be identified. Measurement time: 0, 24, 48h, 72h, 120h, 168h, 14 days, 21 days y 28 days.
Effect:
3. Rate of deceased patients in 14 days following the use of the drug. Measurement time: at 14 days
4. Rate of patients with disease progression (clinical or radiological worsening in the classification of clinical status). Measurement time: 0, 48h, 72h, 120h, 168h, 14 days, 21 days y 28 days.
Key secondary outcomes:
1. Pulmonary function (Rate of patients who improve the PO2/FiO2 ratio, Oro-tracheal intubation rate, measured as the rate of patients requiring intubation, Duration of mechanical ventilation or time to deteste, Chest X-ray). Measurement time: 0, 24h, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days
2. Inflammation Markers (NLR, IL6, Interferon gamma, C-reactive protein). Measurement time: Day 0, at 72 hours, 120 and, 168 hours after the use of the drug.
3. Clinical Laboratory (Hemoglobin (Hb), Total Leukocytes, Neutrophils, Lymphocytes, Platelets, Erythrosedimentation, Triglycerides, Ferritin, Creatinine, LDH (Lactate dehydrogenase), Amino-aspartate transferase, Pyruvic glutamic transferase, Complete Pyruvic Coagulogram, according the lab units). Measurement time: 0, 24h, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days