A Phase 2 interventional study of Firazyr and SoC in COVID-19 Pneumonia, sponsored by Sebastian Videla. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by Sebastian Videla · Phase 2, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 73 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Sebastian Videla is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: SoC
Drug: Firazyr · Other: SoC
Icatibant 10 MG/ML Prefilled Syringe
The SoC could include respiratory support measures, fluid therapy, antipyretic treatment, postural measures, low-molecular-weight-heparins, corticosteroids, such as dexamethasone, remdesivir and other therapeutic options
Efficacy of experimental treatment
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.
Time frame: up to 10 days
Safety of experimental treatment
Number of patients without an adverse reaction scoring 3, 4 or 5 according to the Criteria of Adverse Event Terminology (CTC-AE).
Time frame: up to 10 days
Long-term efficacy
Number (percentage) of patients who reach grade 2 or grade 1 during the 10 days of to have initiated treatment.
Time frame: up to 10 days
Time to achive a clinical response
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
Time frame: up to 40 days
Time to achive an afebrile state
period time (days) to reach a 48-hour sustained afebrile state (i.e., body temperature ≤ 37.5ºC) without antipyretic medication.
Time frame: up to 40 days
time from symptom onset to treatment
period time (days) between the first COVID-19-related symptom and visit 1 (treatment start visit).
Time frame: up to day 1
Responders
Number (percentage) of patients considered as responders based on National Early Warning Score 2 (NEWS 2)
Time frame: up to 40 days
COVID-19 related relapse
number (and percentage) of patients discharged who presents any COVID-19-related relapse or comorbidity
Time frame: up to 40 days
Patients with Adverse Events
number of patients with Any Adverse Events
Time frame: up to 40 days
Adverse Events
Number of Adverse Events
Time frame: up to 40 days
Serious Adverse Events
Number of Serious Adverse Events
Time frame: up to 40 days
Overall mortality
number of patients who died
Time frame: up to 40 days
COVID-19 related mortality
number of patients who died due to COVID-19
Time frame: up to 40 days
Time until death
number of days from visit 1 until death
Time frame: up to 40 days
COVID-19-related complications
number of patients who had any COVID-19 related complications
Time frame: up to 40 days
Patients requiring intensive care
number of patients who require intensive care
Time frame: up to 40 days
patients requiring intensive care and invasive mechanical ventilation
number of patients who require intensive care and invasive mechanical ventilation
Time frame: up to 40 days
patients requiring oxygen supplementation
number of patients who require oxygen supplementation from hospital discharge up until visit 7
Time frame: up to 40 days
Patients with nonsocomial infection
number (and percentage) of patients diagnosed with another nosocomial infection
Time frame: up to 40 days
Rehospitalizations
number (and percentage) of patients who requires hospital readmission within 28 (± 3) days from hospital discharge
Time frame: up to 40 days
Plan to share: Undecided
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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