Efficacy: Need for mechanical ventilation;Efficacy: Death from any cause;Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level;Efficacy: Any of the following analytical data after 72h of randomization.;Safety: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).

Efficacy: Need for mechanical ventilation;Efficacy: Death from any cause;Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level;Efficacy: Any of the following analytical data after 72h of randomization.;Safety: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).