Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Efficacy evaluation respiratory discomfort
研究概览
简要总结
The main objective of this study is to evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections.
详细描述
Prospective, prospective, multicentre, double-blind, randomised, multi-centre study of three parallel groups of patients:
- Group 1 (n=15): standard of care + C1 inhibitor
- Group 2 (n=15): standard care + icatibant + C1 inhibitor
- Group 3 (n=15): standard support + placebo
The study has two parts:
- A 4-day (96-hour) therapeutic part during which the patient will be evaluated nine times (H0, H4, H12, H24, H36, H48, H60, H72 and H96).
- A follow-up part of 6 days with at least two assessments (D7 and D10).
The maximum duration of patient participation in the study will be 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
- Double (Participant, Investigator)
盲法说明
Double blind
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
- •Patient over 18 years of age, having read and signed the consent form for participation in the study after the reflection period (≤ 15 minutes)
- •Patient screened for COVID+ by RT-PCR on nasopharyngeal swab
- •Patient with at least three of the following respiratory signs:
- •Temperature >38° C
- •Non-productive dry cough
- •Presence of crackling rales on auscultation
- •Respiratory discomfort felt by the patient
- •Heart rate > 90/min
- •Respiratory rate >20/min
- •O2 saturation ≤ 93%
- •Patient whose clinical condition, in the opinion of the investigator, requires hospital monitoring.
- •Patient who would have been monitored and treated outside of study participation, including prevention of thromboembolic risk with LMWH.
排除标准
- •Patient with pre-existing respiratory disease (cancer, COPD, asthma, emphysema) or smoking history of > 25 years)
- •Patient with a known allergy to one of the study products
- •Patient treated with anti TNF, IL1 or IL6
- •Patient requiring immediate intubation
- •Patient on a low sodium diet
- •Patient under protective custody, guardianship or trusteeship
- •Patient not affiliated to the French social security system
- •Patient participating in another therapeutic protocol
- •Pregnant or likely to become pregnant (woman of childbearing age without effective contraception and without HCG dosage)
- •Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient
研究组 & 干预措施
standard care + C1 inhibitor
The C1 inhibitor will be used at a dose of 1000 units per slow infusion (two hours). Two infusions will be given 24 hours apart. These doses correspond to the usual doses used in the treatment of conditions in which the C1-Inhibitor is indicated.
干预措施: C1 Inhibitor Human (Drug)
standard care + C1 inhibitor
The C1 inhibitor will be used at a dose of 1000 units per slow infusion (two hours). Two infusions will be given 24 hours apart. These doses correspond to the usual doses used in the treatment of conditions in which the C1-Inhibitor is indicated.
干预措施: Placebo (Other)
standard care + Icatibant + C1 inhibitor
The C1 inhibitor will be used at a dose of 1000 units per slow infusion (two hours). Two infusions will be given 24 hours apart. These doses correspond to the usual doses used in the treatment of conditions in which the C1-Inhibitor is indicated.
The icatibant will be used in a single injection of 30 mg subcutaneously, preferably in the abdominal region. These doses correspond to the doses usually used in the treatment of conditions in which icatibant is indicated.
干预措施: C1 Inhibitor Human (Drug)
standard care + Icatibant + C1 inhibitor
The C1 inhibitor will be used at a dose of 1000 units per slow infusion (two hours). Two infusions will be given 24 hours apart. These doses correspond to the usual doses used in the treatment of conditions in which the C1-Inhibitor is indicated.
The icatibant will be used in a single injection of 30 mg subcutaneously, preferably in the abdominal region. These doses correspond to the doses usually used in the treatment of conditions in which icatibant is indicated.
干预措施: Icatibant Injection (Drug)
standard care + placebo
干预措施: Placebo (Other)
结局指标
主要结局
Efficacy evaluation respiratory discomfort
时间窗: 96 hours after the administration of treatment
To evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections. The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : * no respiratory discomfort * heart rate between 60 and 90 /min * respiratory rate less than 20/min * O2 saturation greater than 94% without oxygen supply
Efficacy evaluation heart rate between 60 and 90 /min
时间窗: 96 hours after the administration of treatment
To evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections. The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : * no respiratory discomfort * heart rate between 60 and 90 /min * respiratory rate less than 20/min * O2 saturation greater than 94% without oxygen supply
Efficacy evaluation respiratory rate less than 20/min
时间窗: 96 hours after the administration of treatment
To evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections. The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : * no respiratory discomfort * heart rate between 60 and 90 /min * respiratory rate less than 20/min * O2 saturation greater than 94% without oxygen supply
Efficacy evaluation O2 saturation greater than 94% without oxygen supply
时间窗: 96 hours after the administration of treatment
To evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections. The evaluation of the treatment efficacy of the study is based on the clinical monitoring of the patient and particularly on the following combination of criteria as experienced by the patient : * no respiratory discomfort * heart rate between 60 and 90 /min * respiratory rate less than 20/min * O2 saturation greater than 94% without oxygen supply
次要结局
- Tolerance evaluation(Day 10)