2024-519104-27-00
已完成
2 期
Potential of FX06 to improve disease severity in Acute Respiratory Distress Syndrome patients (Ixion 2.0)
F4-Pharma Ges.m.b.H.6 个研究点 分布在 5 个国家目标入组 263 人开始时间: 2024年11月25日最近更新:
概览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- F4-Pharma Ges.m.b.H.
- 入组人数
- 263
- 试验地点
- 6
- 主要终点
- The primary objective is to demonstrate a difference in the time to initial unassisted breathing (UAB) in patients receiving FX06 compared to patients receiving placebo until day 28. • Time to initial unassisted breathing (UAB) until day 28 in both treatment groups
概览
简要总结
The primary objective is to demonstrate a difference in the time to initial unassisted breathing (UAB) in patients receiving FX06 compared to patients receiving placebo until day 28. • Time to initial unassisted breathing (UAB) until day 28 in both treatment groups.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Hospitalised patients with mild to moderate ARDS according to the Berlin Definition of ARDS or patients with assisted breathing (without the use of PEEP) and high oxygen demand (e.g., HFNO ≥ 30 L/min) who fulfil the other criteria of the Berlin Definition of ARDS (modified Berlin criteria) (for clarification see Table 1) (Note: Patients requiring PEEP will be eligible if they fulfil the criteria of the Berlin Definition as long as they are not defined as severe ARDS according to exclusion criterion 2.)
- •Patients ≥ 18 years
- •Randomization within 48h of ARDS diagnosis
- •Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient or his/her legal representative
- •Patients or their legal representatives able to understand the requirements of the study and give written informed consent
排除标准
- •>48 hours of invasive mechanical ventilation before randomization
- •History of or current acohol or drug abuse (*1) (*1: text are additions only available in the protocol in France version FR V2.3 dated 15.01.2024)
- •Protected patients (i.e. those patients under guardianship and/or curatorship) (*1) (*1: text are additions only available in the protocol in France version FR V2.3 dated 15.01.2024)
- •Severe ARDS according to the Berlin Definition
- •Evidence of other significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases with a bad prognosis that are likely to interfere with the evaluation of the patient’s safety and with the study outcome as judged by the treating physician, e.g.: o Other severe advanced or chronic lung diseases (e.g., COPD Gold ≥ 3, severe silicosis) o Acute respiratory failure due to cardiac failure (NYHA ≥ III) or fluid overload o Pre-existing haematological disease with severe leukopenia, severe thrombocytopenia or severe anaemia (*1) o Severe renal impairment (*1) o Advanced hepatic insufficiency or severe liver disease (e.g., liver cirrhosis CHILD C) o Use of chronic (> 3 months) long-term oxygen therapy before randomization o Exacerbation of asthma o Septic shock
- •Any contraindications to use the IMP (e.g., allergy or intolerance against the IMP or its ingredients)
- •Is currently being detained in an institution by a governmental or judicial order
- •Do not intubate order
- •Women pregnant or breastfeeding
- •Males or females of reproductive potential not willing to use effective contraception for the duration of the study period (defined as PEARL index –1 - e.g., contraceptive pill, IUD or true sexual abstinence, bilateral tubal occlusion or male partner with vasectomy; also see chapter 19.2 for guidance)
结局指标
主要结局
The primary objective is to demonstrate a difference in the time to initial unassisted breathing (UAB) in patients receiving FX06 compared to patients receiving placebo until day 28. • Time to initial unassisted breathing (UAB) until day 28 in both treatment groups
The primary objective is to demonstrate a difference in the time to initial unassisted breathing (UAB) in patients receiving FX06 compared to patients receiving placebo until day 28. • Time to initial unassisted breathing (UAB) until day 28 in both treatment groups
次要结局
- at all available visits and time points between the FX06 and placebo group • Disease progression/improvement
- Lung function (partial oxygen pressure in the blood, fraction of inspired oxygen, Horowitz index) at BL, D3, D6, D10 and D28
- Systemic inflammation (changes and normalisation in troponin, procalcitonin, CRP, leukocyte count, ferritin, D-dimers, lactate, lactate dehydrogenase, albumin, IL-6)
- Survival / Mortality
- Capillary refill time
- Duration of hospital and ICU stay
- Subgroup analysis by concomitant medication, age, sex, and ARDS cause
- Safety parameters (evaluated for safety set)
研究者
Dr. Petra Wülfroth
Scientific
F4-Pharma Ges.m.b.H.
研究点 (6)
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