Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients With SARS-CoV-2 (COVID-19) Infection

Randomized, Open, Multicenter Phase II Clinical Trial, Proof of Concept, to Evaluate Efficacy and Safety of Icatibant in Hospitalized Patients With SARS-COV-2 (COVID-19) Without Assisted Ventilation Compared With Standard Care

To study the efficacy and safety of icatibant in adult patients admitted to hospitalization units for pneumonia caused by COVID-19, without mechanical ventilation, 10±1 days after starting treatment or discharge from hospital if this occurs before 10 days.

Inclusion Criteria:

1. adult patients (18 years or older), both sexes
2. Sars-CoV-2 infection confirmed by PCR less than 4 days before randomization
3. hospitalized with a diagnosis of SARS-CoV-2 pneumonia
4. radiographic evidence of pulmonary infiltrates
5. grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition
6. pO2/FiO2 <380
7. men and women of childbearing age who have heterosexual relations must be agreement to use the safe method(s) of contraception
8. obtaining the informed consent of the patient or the legal representative.

Exclusion Criteria:

1. imminent death (life expectancy less than 72h)
2. known hypersensitivity or known adverse reactions to the study drug, or its metabolites or excipients of the formulation
3. invasive mechanical ventilation
4. participation in any other clinical trial
5. ALT or AST > 5 x ULN
6. creatinine clearance <50 mL/min using the Cockcroft-Gault formula for participants '18 years old [Cockcroft 1976]
7. patients with recent acute coronary syndrome (<1 month)
8. patients with a history of stroke
9. positive pregnancy test
10. pregnant or lactating woman