Study to improve disease severity of patients with ARDS by treatment with FX06

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 263

Inclusion Criteria

1. 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)
2. Patients = 18 years
3. Randomization within 48h of ARDS diagnosis
4. Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient or his/her legal representative
5. Patients or their legal representatives able to understand the requirements of the study and give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 217
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

1. >48 hours of invasive mechanical ventilation before randomization
2. Severe ARDS according to the Berlin Definition
3. 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.:
- Other severe advanced or chronic lung diseases (e.g., COPD Gold = III, severe silicosis)
- Acute respiratory failure due to cardiac failure (NYHA = III) or fluid overload
- Advanced hepatic insufficiency or severe liver disease (e.g., liver cirrhosis CHILD C)
- Use of chronic (> 3 months) long-term oxygen therapy before randomization
- Exacerbation of asthma
- Septic shock
4. Any contraindications to use IMP (e.g.allergy or intolerance against IMP or its ingredients)
5. Is currently being detained in an institution by a governmental or judicial order
6. Do not intubate order
7. Women pregnant or breastfeeding
8. 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)
9. Current participation in another interventional clinical trial with IMP or participation within the last 30 days

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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