COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005059-35/DE

Fraunhofer ITMP - Clinical Research

ClincialResearch@itmp.fraunhofer.de

2021-12-06

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

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.: 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 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 4. Any contraindications to use the IMP (e.g., allergy or intolerance against the 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

2

F4-Pharma GmbH i.G.

18

100

Austria

Severe disease at enrollment

6: Severe disease at enrollment

100

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 Unassisted breathing is defined as: Without invasive ventilation for 48h consecutively for patients with invasive ventilation at BL and neither invasive nor non-invasive ventilation (including HFNO) for 48h consecutively for patients with non-invasive ventilation (including HFNO) at BL. Continuous or bilevel positive airway pressure (CPAP, BIPAP) solely for sleep-disordered breathing management is not defined as assisted breathing. Also, non-mechanical oxygen supplementation will not be defined as assisted breathing.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 530, "treatment_name": "Fx06", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]