Coronavirus pneumonia
Conditions
Interventions
Group A (experimental)- 60 participants
patients will receive Firazyr® (Icatibant acetate 30 mg), a subcutaneous injection in the abdominal area administered at intervals of 8 hours for 4 days, plus s
Drug
D27.505.519.265.500
Sponsors
Faculdade de Ciências Médicas da Universidade Estadual de Campinas
Hospital de Clínicas da Universidade Estadual de Campinas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged 18 years at the time of signing Consent Form, 12 days since onset of the symptoms until the start of treatment, SARS-CoV-2 diagnosis by RT-PCR method, pneumonia confirmed by computed tomography of the chest, hospitalized patients with a SpO2 < 94% in ambient air or Pa02/FiO2 < 300 mmHg, the patient or responsible family member (incapacitated patients) must have signed the consent form, the patient must agree not to enrol in any other experimental study prior to completing the 28-day follow-up.
Exclusion criteria
Exclusion criteria: Women in pregnancy or breastfeeding (pregnancy-beta-HCG-test will be performed in women of childbearing age), known severe renal impairment (estimated glomerular filtration rate < 30 ml/min/1.73 m2), or patients receiving continuous renal replacement therapy (hemodialysis or peritoneal dialysis); or previous renal transplant; known severe liver disease (AST or ALT 5X above the reference value); patients diagnosed with HIV infection or patient with any other immunodeficiencies; patients with the previous diagnosis of cancer; patients with the previous diagnosis of hereditary angioedema; patients with previous ischemic myocardial disease; patients with previous thromboembolic disease; if the assisting physician considers that the participation of the patient in the study is not appropriate, either because it is not of clinical interest or because of any condition that does not allow the protocol to be followed safely; the patient will be transferred to any other hospital before the 28 days of follow-up or before a disclosure (discharge from hospital); receipt of any experimental treatment for COVID-19 virus infection within 30 days prior to molecular screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to clinical improvement (TTCI), which refers to the time from randomization to an improvement of two points on the seven-category ordinal scale stated below or live discharge from the hospital: 1. not hospitalized with a resumption of normal activities; 2. not hospitalized, but unable to resume normal activities; 3. hospitalized, not requiring supplemental oxygen; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized, requiring nasal high-flow oxygen therapy or non-invasive mechanical ventilation; 6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7. death. The time for clinical improvement or even hospital discharge will be measured in days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient’s clinical status, measured on day 7, day 14 and day 21 after randomization, according to the ordinal scale of seven categories indicated below :1. not hospitalized with a resumption of normal activities; 2. not hospitalized, but unable to resume normal activities; 3. hospitalized, not requiring supplemental oxygen; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized, requiring nasal high-flow oxygen therapy or non-invasive mechanical ventilation; 6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7. death.;Time from randomization to hospital discharge (if the same occurs before the follow-up of 28 days) measured in days, and verified from the analysis of the medical record.;Time from randomization to death (if the same occurs before the follow-up of 28 days) measured in days, and verified from the analysis of the medical record.;Need of oxygen support in days. The need of oxygen support is understood as the use of O2 in percentages above 21% in gas mixtures independent of the device for supply (via nasal catheter, mask or nasal or orotracheal intubation). This will be verified from the analysis of the medical record.;Duration of mechanical ventilation, measured in days, and verified from the analysis of the medical record.;Occurrence of acute kidney injury, defined as an increase in creatinine by 1.5 times above the baseline value of the patient. It will be considered the basal value of creatinine that obtained in the exam performed in the allocation (D0).;Incidence of serious adverse events (SAE) and severity of all adverse events (AE), as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). The measurements will be taken before the treatment on day -1, during the treatment daily, from day 1 to day 28 and at the follow-up end on day 28. These data will be verified from the analysis of the medical record. | — |
Countries
Brazil
Contacts
Public ContactLício Velloso
Universidade Estadual de Campinas
Outcome results
None listed