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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Safety of experimental treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Standard of Care (SoC)
干预措施: SoC (Other)
SoC + Icatibant
干预措施: Firazyr (Drug)
SoC + Icatibant
干预措施: SoC (Other)
结局指标
主要结局
Safety of experimental treatment
时间窗: 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
时间窗: 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.
次要结局
- COVID-19 related mortality(up to 40 days)
- Patients with nonsocomial infection(up to 40 days)
- Rehospitalizations(up to 40 days)
- Responders(up to 40 days)
- Patients with Adverse Events(up to 40 days)
- Long-term efficacy(up to 10 days)
- Time to achive an afebrile state(up to 40 days)
- time from symptom onset to treatment(up to day 1)
- Adverse Events(up to 40 days)
- Time until death(up to 40 days)
- COVID-19-related complications(up to 40 days)
- patients requiring intensive care and invasive mechanical ventilation(up to 40 days)
- patients requiring oxygen supplementation(up to 40 days)
- Time to achive a clinical response(up to 40 days)
- COVID-19 related relapse(up to 40 days)
- Serious Adverse Events(up to 40 days)
- Patients requiring intensive care(up to 40 days)
- Overall mortality(up to 40 days)
研究者
Sebastian Videla
Head of the Clinical Research Support Unit
Hospital Universitari de Bellvitge