Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients With SARS-CoV-2 (COVID-19) Infection
- Registration Number
- NCT04978051
- Lead Sponsor
- Sebastian Videla
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- adult patients (18 years or older), both sexes
- Sars-CoV-2 infection confirmed by PCR less than 4 days before randomization
- hospitalized with a diagnosis of SARS-CoV-2 pneumonia
- radiographic evidence of pulmonary infiltrates
- grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition
- pO2/FiO2 <380
- men and women of childbearing age who have heterosexual relations must be agreement to use the safe method(s) of contraception
- obtaining the informed consent of the patient or the legal representative.
- imminent death (life expectancy less than 72h)
- known hypersensitivity or known adverse reactions to the study drug, or its metabolites or excipients of the formulation
- invasive mechanical ventilation
- participation in any other clinical trial
- ALT or AST > 5 x ULN
- creatinine clearance <50 mL/min using the Cockcroft-Gault formula for participants '18 years old [Cockcroft 1976]
- patients with recent acute coronary syndrome (<1 month)
- patients with a history of stroke
- positive pregnancy test
- pregnant or lactating woman
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care (SoC) SoC - SoC + Icatibant Firazyr - SoC + Icatibant SoC -
- Primary Outcome Measures
Name Time Method Safety of experimental treatment up to 10 days Number of patients without an adverse reaction scoring 3, 4 or 5 according to the Criteria of Adverse Event Terminology (CTC-AE).
Efficacy of experimental treatment up to 10 days Number of patients reaching grade 2 (inpatient, no longer requiring supplemental oxygen and no longer requiring care or grade 1 (hospital discharge) of the ordinal scale of the clinical state of the patient for 48 hours.
- Secondary Outcome Measures
Name Time Method COVID-19 related mortality up to 40 days number of patients who died due to COVID-19
Patients with nonsocomial infection up to 40 days number (and percentage) of patients diagnosed with another nosocomial infection
Rehospitalizations up to 40 days number (and percentage) of patients who requires hospital readmission within 28 (± 3) days from hospital discharge
Responders up to 40 days Number (percentage) of patients considered as responders based on National Early Warning Score 2 (NEWS 2)
Patients with Adverse Events up to 40 days number of patients with Any Adverse Events
Long-term efficacy up to 10 days Number (percentage) of patients who reach grade 2 or grade 1 during the 10 days of to have initiated treatment.
Time to achive an afebrile state up to 40 days period time (days) to reach a 48-hour sustained afebrile state (i.e., body temperature ≤ 37.5ºC) without antipyretic medication.
time from symptom onset to treatment up to day 1 period time (days) between the first COVID-19-related symptom and visit 1 (treatment start visit).
Adverse Events up to 40 days Number of Adverse Events
Time until death up to 40 days number of days from visit 1 until death
COVID-19-related complications up to 40 days number of patients who had any COVID-19 related complications
patients requiring intensive care and invasive mechanical ventilation up to 40 days number of patients who require intensive care and invasive mechanical ventilation
patients requiring oxygen supplementation up to 40 days number of patients who require oxygen supplementation from hospital discharge up until visit 7
Time to achive a clinical response up to 40 days period time (days) between visit 1 (treatment start visit) and the day of gathering sustained 48-hour grade 2, grade 1 or grade 0 classification on the WHO 8-point ordinal scale for clinical status assessment The patient must be discharged from the hospital by the 28th day without a relapse or comorbidity related to COVID-19
COVID-19 related relapse up to 40 days number (and percentage) of patients discharged who presents any COVID-19-related relapse or comorbidity
Serious Adverse Events up to 40 days Number of Serious Adverse Events
Patients requiring intensive care up to 40 days number of patients who require intensive care
Overall mortality up to 40 days number of patients who died
Trial Locations
- Locations (1)
Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet De Llobregat, Catalonia, Spain