Primary Outcomes
Description: 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).
Measure: 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).
Time: 30 days after enrollment
Measure: Efficacy: Death from any cause
Time: Day +21 after randomization
Measure: Efficacy: Need for mechanical ventilation
Time: Day +21 after randomization
Description: IL-6> 40 pg / mL, D-dimer> 1500, ferritin> 1000ng / mL.
Measure: Efficacy: Any of the following analytical data after 72h of randomization.
Time: Day +21 after randomization
Measure: Efficacy: SOFA scale ≥ 3 after 72 hours of randomization.
Time: Day +21 after randomization
Secondary Outcomes
Measure: Efficacy. Mortality on days 14 and 28.
Time: Days 14 and 28.
Measure: Efficacy: Proportion of patients who required mechanical ventilation
Time: Until day 28
Description: IL-6> 40 pg / mL, D-dimer> 1500, ferritin> 1000ng / mL until the cure test.
Measure: Efficacy: Proportion of patients who develop analytical alterations.
Time: Day +21 after randomization.
Measure: Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.
Time: Day +21 after randomization
Measure: Efficacy: PCR negative for SARS-CoV-2
Time: On days 7, 14 and 21
Measure: Efficacy: Proportion of patients who required treatment with Tocilizumab
Time: Until day 21.
Measure: Efficacy: Duration of hospitalization (days)
Time: Until day 21.
Measure: Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample
Time: At baseline and on day 14
Measure: Virology and immunological variables: Total antibody quantification
Time: At baseline and on days 3, 7, 10 (while hospitalization lasts), and on days 14 and 28 (if you can return to the clinic or are still hospitalized).
Measure: Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.
Time: Before infusion